SleepFlexTM Treatment of Obstructive Sleep Apnea

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the safety and effectiveness of the SleepFlex program for treatment of mild to moderate OSA

Official Title
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SleepFlexTM Treatment of Obstructive Sleep Apnea

Conditions
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Obstructive Sleep Apnea

Intervention / Treatment
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* Device: SleepFlex


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 21 years and older Mild to moderate OSA, defined as AHI >10 - 30 events/hour, documented by polysomnogram or home sleep apnea test within 180 days prior to study enrollment Central or mixed disordered breathing events (≤25% of total number of events) Unable to tolerate or decline positive airway pressure therapy Body mass index ≤32 kg/m2 Able to protrude tongue ≥20 mm beyond maxillary incisors Absence of markedly enlarged tonsils, defined as 3+ or 4+ according to the Brodsky classification No uncontrolled sleep disorder other than OSA such as narcolepsy, chronic insomnia, restless legs syndrome, or REM behavior disorder Absence of excessive daytime sleepiness, defined by Epworth Sleepiness Scale score >10 No uncontrolled nasal obstruction Absence of moderate to severe mandibular insufficiency No previous surgery involving the oral cavity or pharynx other than tonsillectomy No previous radiation therapy to the head and neck No known neurologic, cardiac (other than hypertension controlled with a single medication), pulmonary, renal, hepatic, or psychiatric disorders No psychiatric diagnoses other than treated depression or mild anxiety Stable medication regimen for ≥1 month No acute illness or infection Ownership of personal smartphone with iOS or Android operating system No known hypersensitivity to any material of the SleepFlex devices Exclusion Criteria: Unwilling or unable to provide informed written consent in English Pregnancy, breastfeeding, or plans to become pregnant Smoker (tobacco or recreational drugs) in the past month Alcohol consumption, averaged over the previous month, greater than 2 alcoholic beverages per day Significant vision or hearing problems Unwilling or incapable of returning for all follow-up visits and conduct sleep studies at home, including the evaluation procedures and filling out questionnaires Any other reason the investigator determines as being unfit for study participation

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SleepFlex Treatment<br> | Device: SleepFlex<br>* SleepFlex Program<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Freedom From SleepFlex-related Serious Adverse Events | Number of participants with absence of serious adverse events related to the SleepFlex system. | 12 weeks | 
| Change in the Apnea-hypopnea Index (AHI) | Change in the apnea-hypopnea index (AHI) on post-treatment vs. pre-treatment home sleep apnea test. Apneas are defined by >=80% reduction in airflow for >= 10 seconds in the presence of respiratory effort. Hypopneas are defined by >=50% reduction in airflow with oxygen desaturation of >=3% in the presence of respiratory effort. The Apnea-hypopnea index (AHI) is the sum of the apneas and hypopneas divided by the hours of recording time. AHI values are typically categorized as 5-15/hr = mild; 15-30/hr = moderate; and >= 30/h = severe. | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Development of Side Effects: Mouth, Throat, or Neck Pain; Dysphagia | Number of participants with development of the following potential side effects: mouth, throat, or neck pain; dysphagia. This was assessed repeatedly throughout the study. | 12 weeks |