Sleep Apnea

Sleep apnea is often thought of as a simple sleep disorder, but research continues to reveal its far-reaching effects on health. A recent study highlights a significant connection between sleep apnea and an increased risk of dementia in women, emphasizing the importance of early diagnosis and effective treatment.

Understanding the Sleep Apnea and Dementia Connection & Research

A study published in Sleep Advances found that women with obstructive sleep apnea (OSA) face a higher risk of developing dementia compared to men. According to Dr. Tiffany Joy Braley, lead author and associate professor of neurology at the University of Michigan, OSA is “a common, under-diagnosed yet treatable condition that is associated with important pathological changes in the brain…[that] overlap with many brain changes seen in people with cognitive decline and dementia.”

The 10-year longitudinal study also noted sex-specific differences in dementia risk, with coauthor Galit Levi Dunietz, PhD, MPH, highlighting that “women may be at higher risk for dementia” due to factors such as longer life expectancy, health behaviors, and social determinants of health.

This research provides further evidence of the critical role sleep plays in brain health and how untreated sleep apnea may accelerate cognitive decline.

Why Sleep Matters for Brain Health

Sleep plays a vital role in cognitive function and overall health. During deep sleep, the brain undergoes critical processes, such as clearing out waste products and consolidating memories. When sleep is disrupted by apnea, these restorative activities are impaired, potentially accelerating cognitive decline.

Noninvasive Solutions for Sleep Apnea

If you or a loved one suspects sleep apnea, seeking treatment is essential—not just for better sleep, but also for long-term brain health. While continuous positive airway pressure (CPAP) machines are a well-known option, many patients struggle with their use due to discomfort or inconvenience.

Fortunately, oral appliance therapy offers a practical and effective alternative. These custom-fitted devices gently reposition the jaw to keep the airway open during sleep, reducing apnea episodes without the bulk of a machine. Many patients find oral appliances more comfortable and easier to maintain, making them a great solution for long-term compliance.

The Importance of Early Intervention

If you snore, wake up feeling tired, or suspect you might have sleep apnea, don’t wait to seek help. Early intervention can not only improve your sleep quality but also protect your cognitive health as you age. Women, in particular, should be vigilant about monitoring their sleep patterns and addressing any concerns promptly.

Take the First Step Toward Better Sleep and Brain Health

At Sleep Better Columbus, we specialize in providing noninvasive oral appliance therapy for sleep apnea. Our team is committed to helping you achieve restful, restorative sleep and protecting your long-term health.

If you’re ready to reduce your risk of dementia and improve your quality of life, contact us today to schedule a consultation. Call us at 614-777-7350 or visit SleepBetterColumbus.com to learn more about our services. Together, we’ll help you reclaim your nights and safeguard your future.

Sleep apnea and temporomandibular joint (TMJ) disorders are two conditions that can significantly impact a person’s health, especially when experienced together. Sleep apnea, a condition where breathing repeatedly stops and starts during sleep, can cause disruptions in a person’s rest and lead to various health problems. TMJ disorders, on the other hand, affect the jaw joint and surrounding muscles, potentially causing pain and discomfort and even influencing sleep quality. For individuals who experience both sleep apnea and TMJ disorders, understanding the connection between these two conditions is essential for managing symptoms and improving overall well-being.

What is Sleep Apnea and How Does It Affect Your Health?

Sleep apnea is a disorder that causes breathing interruptions during sleep. The pauses can last several seconds or longer and may occur multiple times throughout the night. There are two main types of sleep apnea: obstructive sleep apnea (OSA) and central sleep apnea.

The Different Types of Sleep Apnea

• Obstructive Sleep Apnea (OSA): This is the most common form of sleep apnea caused by a physical blockage of the upper airway. In OSA, the muscles in the back of the throat relax excessively during sleep, obstructing airflow and causing the individual to stop breathing temporarily.
• Central Sleep Apnea: Central sleep apnea differs from OSA because the brain does not send the correct signals to the muscles responsible for breathing. Although less common, this type can still lead to serious health issues.
• Complex Sleep Apnea: This combination of obstructive and central sleep apnea.

Common Symptoms of Sleep Apnea

The symptoms of sleep apnea can range from mild to severe and often disrupt an individual’s daily life. Common signs include:

• Loud, persistent snoring
• Excessive daytime sleepiness
• Difficulty concentrating
• Morning headaches
• Dry mouth or sore throat upon waking
• Shortness of breath during sleep

Health Risks Associated with Untreated Sleep Apnea

If sleep apnea is not treated, it can result in several serious health complications, including:

• High blood pressure
• Heart disease
• Stroke
• Diabetes
• Mood disorders like anxiety or depression
• Decreased quality of life due to chronic fatigue and irritability

Addressing sleep apnea early is critical to avoiding these health risks and improving overall well-being.

What is TMJ, and How Does It Impact Your Jaw and Sleep?

TMJ disorders, known as temporomandibular joint disorders, affect the jaw joint and the muscles responsible for controlling jaw movement. The temporomandibular joint is located on each side of the head, connecting the jawbone to the skull. When this joint and the surrounding muscles become inflamed, injured, or stressed, it can lead to various symptoms that impact daily activities, including eating, speaking, and even sleeping.

Defining TMJ Disorders

TMJ disorders can result from a range of factors, including injury to the jaw, teeth grinding (bruxism), misalignment of the teeth or jaw, stress, or even arthritis. These conditions can cause the jaw to move incorrectly, resulting in pain and discomfort in the jaw, face, neck, and shoulders.

Common Causes of TMJ Dysfunction

Several factors can contribute to the development of TMJ disorders, including:

• Teeth Grinding or Jaw Clenching: Often a response to stress or anxiety, these habits can put excessive pressure on the jaw joint, leading to pain and dysfunction.
• Jaw Misalignment: If the upper and lower teeth do not fit together correctly, it can affect the function of the TMJ and cause discomfort.
• Injury to the Jaw: Trauma to the jaw from an accident or injury can lead to TMJ problems.
• Arthritis or Other Joint Conditions: Conditions like osteoarthritis or rheumatoid arthritis can also affect the TMJ, leading to inflammation and pain.

Symptoms of TMJ Disorders

Individuals with TMJ disorders often experience symptoms such as:

• Discomfort or sensitivity in the jaw, neck, or shoulders.
• Sounds such as clicking or popping can occur when moving the jaw.
• Difficulty or pain while chewing
• Headaches, often similar to tension headaches
• Locking or limited movement of the jaw
• Earaches or a feeling of fullness in the ears

For those who experience TMJ dysfunction, these symptoms can become more pronounced when attempting to sleep, further complicating the ability to get restful sleep.

How Sleep Apnea and TMJ Disorders Are Connected

While sleep apnea and TMJ disorders may appear to be separate conditions, they are often interconnected in ways that can exacerbate each other’s symptoms. The relationship between sleep apnea and TMJ disorders is not always immediately apparent. Still, research has shown that individuals who suffer from one condition are at an increased risk of developing the other.

The Overlap of Symptoms Between Sleep Apnea and TMJ

Both sleep apnea and TMJ disorders can cause jaw discomfort and disrupt sleep. Individuals with sleep apnea may experience increased muscle tension in the jaw, especially at night, as the body attempts to compensate for restricted airflow. Similarly, people with TMJ disorders may find their symptoms worsen during sleep, mainly if they grind their teeth or clench their jaw while trying to breathe.

In some cases, the physical and emotional stress associated with sleep apnea may increase the likelihood of teeth grinding or jaw clenching, both of which contribute to TMJ dysfunction. Additionally, the sleep disruption caused by sleep apnea can increase stress levels, further contributing to TMJ-related issues.

Why TMJ Disorders Can Worsen Sleep Apnea

The presence of a TMJ disorder can worsen sleep apnea symptoms. Jaw misalignment, a common issue for TMJ patients, can interfere with the proper airway functioning during sleep. If the jaw is out of alignment, it may cause the airway to collapse more efficiently, leading to more frequent apneas or hypopneas (partial airway blockages) during sleep.

Furthermore, individuals who clench or grind their teeth due to TMJ may experience more pressure on the jaw and surrounding muscles, which could exacerbate breathing difficulties at night. The added strain on the jaw muscles may also increase the chances of airway obstruction, creating a cycle that further impairs sleep quality.

How Treating TMJ May Improve Sleep Apnea Symptoms

Addressing TMJ disorders may offer relief for individuals with sleep apnea, especially if jaw misalignment or teeth grinding is a contributing factor. Treatments such as oral appliances or nightguards can help reduce teeth grinding and alleviate pressure on the jaw. In some cases, realigning the jaw or using physical therapy techniques to relieve muscle tension can improve the positioning of the airway, which may reduce the frequency and severity of sleep apnea episodes.

When both conditions are treated in tandem, patients often experience a reduction in the severity of their symptoms, leading to better sleep quality and improved overall health. Collaborative care from a sleep specialist and a TMJ expert is essential to address both issues comprehensively.

Treatment Options for Both Sleep Apnea and TMJ Disorders

When dealing with both sleep apnea and TMJ disorders, it is essential to explore treatment options that can address both conditions simultaneously. Managing these disorders typically requires a multifaceted approach, combining therapies designed for each issue while considering their interactions.

CPAP Therapy and Its Limitations with TMJ

Continuous positive airway pressure (CPAP) therapy is the most common treatment for obstructive sleep apnea. This device uses a mask that delivers a constant airflow to keep the airway open during sleep. While CPAP is highly effective for managing sleep apnea, individuals with TMJ disorders may find it uncomfortable or challenging to use. The mask may put additional pressure on the jaw or cause discomfort, particularly if the patient experiences jaw pain or clenching at night.

Some patients may opt for a more comfortable alternative, such as a dental appliance (a mandibular advancement device). This device works by repositioning the jaw to keep the airway open and may be more suitable for those with TMJ-related discomfort.

TMJ Treatment Approaches for Better Sleep Quality

Treating TMJ disorders involves reducing pain, improving jaw function, and preventing further damage to the joint. Common treatments include:

• Oral Appliances or Nightguards: These devices are designed to avoid teeth grinding and jaw clenching during sleep, which can reduce pressure on the TMJ.
• Physical Therapy: Targeted exercises can help relax the jaw muscles and improve jaw movement, reducing discomfort and improving sleep quality.
• Medications: Nonsteroidal anti-inflammatory drugs (NSAIDs) or muscle relaxants may be prescribed to alleviate pain and inflammation associated with TMJ disorders.
• Surgical Interventions: In severe cases, surgery may be recommended to correct jaw alignment or repair joint damage. However, this is typically a last resort.

Collaborative Care: Working with Sleep and TMJ Specialists

Working with a team of healthcare professionals is crucial for those managing sleep apnea and TMJ disorders. Sleep specialists can help diagnose and manage sleep apnea, while TMJ specialists, including dentists or physical therapists, can offer targeted treatments for jaw dysfunction. By taking a collaborative approach, patients are more likely to find a solution that addresses both conditions and improves their overall quality of life.

Working together, these specialists can recommend a personalized treatment plan that may include CPAP therapy, oral appliances, physical therapy, and lifestyle modifications. Such an approach can help break the cycle of sleep disruption and jaw pain, providing a more restful and pain-free night’s sleep.

Take Action Today – Call Sleep Better Columbus for a Personalized Consultation

If you’re struggling with sleep apnea and TMJ disorders, don’t wait to seek help. Call Sleep Better Columbus today at (614) 777-7350 to schedule a consultation and learn more about how we can help you improve your sleep quality and alleviate discomfort.

Sleep apnea is a common condition that can disrupt a person’s sleep cycle, leading to poor rest and increased daytime fatigue. The impact on productivity and alertness during the day can be significant for those affected by this disorder. Inadequate sleep often results in reduced cognitive performance, difficulty concentrating, and slower reaction times—all of which can affect personal and professional life.

Understanding Sleep Apnea and Its Impact on Daily Life

Sleep apnea is a condition in which breathing is repeatedly interrupted during sleep, often multiple times throughout the night. These disruptions prevent the body from reaching deeper, more restorative sleep stages. The most common form is obstructive sleep apnea (OSA), when the throat muscles relax too much during sleep, temporarily blocking the airway.

What is sleep apnea?

Sleep apnea occurs when an individual experiences interruptions in breathing or shallow breaths during sleep. These pauses can last a few seconds to minutes, disrupting regular sleep cycles and reducing overall sleep quality.

Common symptoms that affect daily functioning

The primary symptom of sleep apnea is loud snoring, often followed by choking or gasping sounds. People with sleep apnea may also experience excessive daytime sleepiness, irritability, difficulty focusing, and memory problems. These symptoms can significantly impair one’s ability to perform daily tasks and be productive.

How sleep apnea disrupts sleep quality

Because sleep apnea prevents the body from achieving deep, restorative sleep, individuals often feel fatigued, even after a whole night in bed. This lack of quality rest leads to sleep deprivation, affecting cognitive performance and daytime alertness.

The Link Between Sleep Apnea and Productivity

Sleep apnea can significantly impact productivity. When individuals don’t get restful sleep due to frequent awakenings during the night, their cognitive functions are impaired, directly affecting their ability to perform tasks efficiently. The connection between sleep apnea and reduced productivity is limited to work and all areas of daily life.

How does poor sleep lead to reduced cognitive function?

Sleep apnea interrupts the deep sleep necessary for cognitive processes such as memory consolidation, problem-solving, and critical thinking. As a result, individuals with untreated sleep apnea may struggle with mental clarity, making it harder to concentrate on tasks and complete them effectively.

The effects of sleep deprivation on work performance

When a person is sleep-deprived due to sleep apnea, it can result in slower reaction times, a lack of focus, and poor decision-making. This can lead to mistakes, missed deadlines, and a decline in the overall quality of work. Long-term sleep deprivation can further contribute to burnout, as individuals cannot maintain consistent energy levels throughout the day.

Increased risk of errors and accidents due to fatigue

Fatigue caused by sleep apnea increases the risk of errors, accidents, and even workplace injuries. Sleep-deprived individuals are less alert, and their ability to stay focused on tasks or notice important details diminishes. This is particularly dangerous in jobs that require attention to detail, such as healthcare or operating machinery, where mistakes can have serious consequences.

How Sleep Apnea Affects Alertness and Mental Sharpness

The effects of sleep apnea extend beyond fatigue and can significantly impact mental sharpness and alertness. Even after a whole night of sleep, individuals with sleep apnea often wake up feeling unrested and find it challenging to stay alert throughout the day. This can have profound implications for both personal and professional performance.

1. Impact on memory and concentration
   • Sleep apnea disrupts the brain’s ability to consolidate memories and process information. This can result in forgetfulness, difficulty retaining new information, and difficulty recalling previously learned material. As concentration wanes, tasks that once seemed straightforward may take longer to complete, further affecting productivity.
2. Slower reaction times and decision-making ability
   • When sleep quality is compromised, cognitive processes such as reaction times and decision-making are also affected. Individuals with sleep apnea may find they are slower to respond in critical situations, affecting personal safety and workplace performance. Poor decision-making can lead to costly errors, especially in high-pressure or fast-paced environments.
3. Increased likelihood of brain fog and daytime drowsiness
   • Daytime drowsiness is a common side effect of sleep apnea. Many individuals experience what is known as “brain fog,” where they feel mentally cloudy, disoriented, and unable to focus. This mental fatigue can lead to irritability, frustration, and a lack of motivation to complete everyday tasks.

Workplace Challenges Associated With Sleep Apnea

For individuals with sleep apnea, the effects on alertness and cognitive function extend into the workplace, where productivity and performance are key. The challenges posed by this sleep disorder can influence job satisfaction, career advancement, and even workplace safety.

Struggles with focus and efficiency

When employees cannot concentrate due to the fatigue caused by sleep apnea, their ability to complete tasks efficiently is hindered. This results in longer work hours, missed deadlines, and a general decline in output quality. Tasks requiring attention to detail can become more complex, leading to frustration and decreased job satisfaction.

Increased absenteeism and presenteeism

Sleep apnea can lead to increased absenteeism, as individuals may feel too exhausted to report to work or take more frequent sick days due to associated health issues. Additionally, presenteeism—when an employee is physically at work but mentally disengaged—can be a problem. Those suffering from sleep apnea may attend work while feeling fatigued or mentally foggy, which can lead to a decline in their performance despite being physically present.

Effects on professional growth and career advancement

Chronic fatigue and cognitive impairment caused by untreated sleep apnea can affect an individual’s ability to meet performance expectations. Over time, this can hinder career advancement opportunities, as the individual may not be seen as reliable or capable in their role. Without proper treatment, the long-term effects of sleep apnea can diminish an individual’s overall professional trajectory.

Sleep Apnea Health Consequences That Further Reduce Productivity

Beyond the immediate effects on productivity and alertness, untreated sleep apnea can lead to a variety of health issues that further compound the challenges faced in daily life. These health problems can exacerbate fatigue and make it even harder to maintain a high level of performance at work or in personal activities.

Higher risk of chronic conditions (e.g., heart disease, diabetes)

Sleep apnea has been linked to several severe health conditions, including heart disease, high blood pressure, stroke, and diabetes. The constant disruption of sleep and its strain on the body can increase the risk of these chronic conditions. As health deteriorates, energy levels drop even further, making staying productive or focused during the day more difficult.

Mental health concerns such as anxiety and depression

The fatigue caused by sleep apnea can also contribute to mental health issues, including anxiety and depression. The persistent lack of rest can lead to irritability, hopelessness, and a lack of motivation. This, in turn, can create a vicious cycle where poor mental health further disrupts sleep and worsens overall well-being, which continues to reduce productivity.

How untreated sleep apnea exacerbates fatigue

Untreated sleep apnea leads to poor sleep quality, which accumulates over time and causes chronic exhaustion. This ongoing fatigue can affect all aspects of a person’s life, reducing their ability to engage in activities, perform well at work, and maintain a healthy, active lifestyle. As a result, untreated sleep apnea can perpetuate a cycle of low energy and decreased productivity.

Ways to Improve Productivity While Managing Sleep Apnea

Managing sleep apnea effectively can help restore energy levels, improve mental sharpness, and ultimately boost daytime productivity. Several strategies—from lifestyle changes to medical treatments—can assist in managing sleep apnea and minimizing its impact on daily life.

Lifestyle Changes to Support Better Sleep

Certain lifestyle adjustments can significantly improve sleep quality, even before seeking medical treatment.

• Maintaining a consistent sleep schedule

Going to bed and waking up simultaneously daily helps regulate the body’s internal clock and improves sleep quality. Even on weekends, maintaining a consistent sleep schedule can help mitigate the effects of sleep apnea on daytime alertness.

• Weight management and exercise

For individuals with sleep apnea, especially obstructive sleep apnea, losing weight and staying physically active can reduce the severity of symptoms. Regular exercise helps improve breathing and reduce the pressure on the airways during sleep, leading to better rest.

• Avoiding alcohol and sedatives before bedtime

Alcohol and sedatives relax the muscles in the throat, which can worsen the symptoms of sleep apnea. Avoiding these substances before bedtime can help prevent airway blockages and improve sleep quality.

Medical Treatments for Sleep Apnea

For many individuals, lifestyle changes alone are insufficient to manage sleep apnea effectively. Medical interventions can help alleviate symptoms and improve both sleep and daytime productivity.

• CPAP therapy and its benefits for energy levels

Continuous Positive Airway Pressure (CPAP) therapy is a common treatment for sleep apnea. A CPAP machine delivers a constant airflow through a mask, helping to keep the airways open during sleep. This treatment can significantly reduce daytime sleepiness and increase energy levels, allowing individuals to feel more alert and productive during the day. However, CPAP machines are not widely tolerated and only work if used properly.

• Oral appliances for sleep apnea

For those who cannot tolerate CPAP therapy, oral appliances are a viable option. These devices, worn in the mouth, help to reposition the jaw and tongue to keep the airway open. Oral appliances can benefit people with mild to moderate obstructive sleep apnea. This non-invasive treatment option for sleep apnea has seen an increase in popularity as specialized sleep apnea dentists like those at Sleep Better Columbus can custom-make these devices to fit a patient’s unique needs.

Workplace Strategies to Counteract Fatigue

In addition to medical treatments, workplace adjustments can help minimize the impact of fatigue caused by sleep apnea.

• Taking strategic breaks throughout the day

Taking short breaks during the workday can help recharge energy levels. Even brief periods of stretching, walking, or relaxation can combat the fatigue caused by sleep apnea and help maintain focus.

• Optimizing workspace for alertness

Creating a workspace that promotes alertness can benefit individuals with sleep apnea. Natural lighting, ergonomic seating, and a comfortable work environment can reduce fatigue and increase productivity.

• Seeking employer support for accommodations

Sometimes, employers may offer accommodations to help employees manage their condition. This could include flexible work hours, the option to work from home, or even quiet spaces for rest during breaks.

How Treating Sleep Apnea Can Boost Daytime Performance

When sleep apnea is effectively treated, the benefits extend beyond improved sleep quality. Treatment can significantly increase energy, better focus, and enhance overall performance in both professional and personal life.

1. Restoring focus and energy
   • One of the most noticeable effects of treating sleep apnea is a marked improvement in daytime energy levels. With better sleep, individuals often feel more awake and alert during the day, allowing them to focus on tasks more effectively. This renewed energy also leads to tremendous enthusiasm and motivation, which can enhance productivity at work and overall quality of life.
2. Improving mood and overall well-being
   • Chronic sleep deprivation due to untreated sleep apnea can cause irritability and mood swings. By treating sleep apnea, many individuals experience a significant improvement in mood and emotional stability. A positive outlook can improve interpersonal relationships, teamwork, and happiness.
3. Improving long-term career success
   • Restoring optimal sleep through treatment supports better cognitive function, decision-making, and problem-solving abilities. Individuals who feel more focused and mentally sharp are better equipped to meet performance expectations and demonstrate leadership skills. This can lead to career advancement and increased opportunities for professional growth.

Take Control of Your Sleep and Productivity

If you suspect sleep apnea is affecting your productivity and alertness, seeking a professional diagnosis and treatment is crucial. Untreated sleep apnea can have long-term effects on your health, job performance, and overall quality of life. By managing the condition proactively, you can restore your energy, focus, and well-being.

Encouragement to seek professional diagnosis and treatment

Sleep apnea is a serious condition but manageable with the proper treatment. If you experience excessive daytime sleepiness, loud snoring, or difficulty staying alert at work, speaking with a healthcare provider is essential. A professional evaluation and diagnosis can help determine the best course of action.

How Sleep Better Columbus can help manage sleep apnea

At Sleep Better Columbus, we specialize in helping individuals manage sleep apnea through various effective treatment options. Our team is dedicated to personalized care, ensuring you receive the best treatment to improve your sleep and daytime productivity.

If you’re ready to take control of your sleep and enhance your productivity, contact Sleep Better Columbus today at (614) 777-7350 to schedule a consultation. Our experts will guide you through your treatment options and help you find the right solution.

Inspire Medical Systems Issues Recall

Inspire Medical Systems has initiated a recall affecting 32 of its Inspire IV implantable pulse generators used for obstructive sleep apnea treatment due to a manufacturing defect. This defect may lead to system malfunctions, including electrical leakage, potentially resulting in serious health issues and the need for revision surgery. The FDA has classified this recall as the most serious type.

Inspire Medical Systems is addressing a manufacturing defect in 32 Inspire IV implantable pulse generators through a field corrective action. This defect can cause electrical malfunctions, posing serious health risks. Affected patients should contact their healthcare providers for routine check-ups and potential revision surgery, while providers need to notify patients and closely monitor the devices. The FDA has identified this recall as the most severe type.

Inspire Medical Systems is recalling its Inspire IV implantable pulse generator model 3028, an essential component of the Inspire upper airway stimulation system for obstructive sleep apnea, due to a manufacturing flaw. This recall involves corrective measures such as informing patients and healthcare providers and conducting additional monitoring. An Inspire Medical spokesperson emphasized that the primary goal is to ensure patient safety without requiring device removal or revision unless absolutely necessary, thereby managing risks while minimizing unnecessary procedures.

The defect can cause system malfunctions post-implantation, leading to electrical leakage in the sensing circuit. Consequently, patients may require revision surgery to replace the pulse generator and restore therapy. The FDA’s recall notice warns that the defect may lead to severe health consequences, including below-normal therapeutic stimulation levels, early battery depletion, inconsistent or inappropriate stimulation effects, painful stimulation, perceived shocking sensations, and even death.

“Patient safety has always been, and continues to be, of paramount importance to Inspire. To that end, we have issued a voluntary field corrective action for all 24 potentially impacted units,” stated Phil Ebeling, chief operating officer at Inspire Medical. According to Ebeling, 24 patients have been notified as part of this action, with eight managed medically, totaling 32 impacted patients. There have been no reported injuries or deaths, according to the FDA’s notice.

Ebeling noted that Inspire Medical has notified regulatory authorities, including the FDA, and sent a letter to affected healthcare providers with specific instructions, including notifying patients of the recall and requesting them to visit the clinic for device testing. “We have also advised healthcare providers to continue monitoring their patients to ensure the devices operate properly and consistently throughout the therapy course,” said Ebeling.

The implantable pulse generator stores therapy settings configured by a physician and delivers mild electrical stimulation to the hypoglossal nerve, which controls tongue muscles to maintain airway patency during sleep. It works with external programmers that allow the physician to set and adjust therapy parameters and the patient to control therapy activation and intensity.

The recall advises regular check-ups and tests to analyze signals and resistance at each visit. According to the Inspire spokesperson, these simple tests can identify device issues without requiring surgery. The FDA has classified this recall as a Class 1 recall, indicating that the device may cause serious injury or death.

Affected Product

Product Name: Inspire IV Implantable Pulse Generator
Unique Device Identifier/Model: 0855728005915/Model 3028
Lot/Serial Numbers: Includes 32 devices of model 3028 implantable pulse generator. See the full list of affected devices.

Actions to Take

Healthcare Providers:

Notify affected patients of this voluntary recall.
Schedule appointments for patients to check if their Inspire therapy is working properly by analyzing signals and resistance. Monitor for any changes in stimulation, therapy effectiveness, or issues with therapy activation.
Continue regular check-ups and tests to analyze signals and resistance at each visit, as these tests can spot device issues without needing surgery.

Patients:

Contact your healthcare provider as soon as possible to ensure you have a routine office visit scheduled.
If you have already been contacted by your healthcare provider, follow up as scheduled.
Attend your scheduled office visit. Routine non-invasive diagnostic monitoring identifies this potential implantable pulse generator defect.

If you experience new symptoms or a reoccurrence of symptoms like fatigue, perceived sleepiness, or snoring problems, contact your sleep physician for a comprehensive evaluation, which may include a polysomnography.

If your provider determines that revision surgery is necessary to replace the implantable pulse generator, you may contact Inspire’s Patient and Physician Services at 1-844-OSA-HELP (1-844-672-4357) for further information.

“Please rest assured that we will continue to cooperate fully and follow up, as appropriate, with regulatory authorities, including the FDA, healthcare providers, and all potentially impacted patients,” stated Ebeling. Healthcare professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.

Sources:

https://sleepreviewmag.com/sleep-treatments/therapy-devices/neurostimulators/inspire-recalls-key-component-neurostimulator-therapy-osa/

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?ID=207939