Adherence to Electrical Glossal In Situ Stimulation for Sleep Apnea (AEGIS Study)

Study Overview
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Brief Summary
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The purpose of this research is to assess how well people with mild obstructive sleep apnea (OSA) adhere to the eXciteOSA device and specifically examine whether adherence of the device is different with low versus high electrical stimulation. In addition, this research study will assess how well the device affects mild sleep apnea and if it improves sleepiness and quality of life.

Official Title
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Adherence to Electrical Glossal In Situ Stimulation for Sleep Apnea

Conditions
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Obstructive Sleep Apnea

Intervention / Treatment
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* Device: eXciteOSA


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age greater than 18 years Ability to consent Home sleep apnea test demonstrating mild obstructive sleep apnea. Smartphone or tablet Exclusion Criteria: Current pacemaker, defibrillator, or neuro-stimulation device No prior oropharyngeal surgery for sleep apnea No implants, metal prostheses, dental braces, or soft tissue/bony ulcerations in the oral cavity No prior use of mandibular advancement device (MAD) or continuous positive airway pressure (CPAP) Heart failure (New York Heart Association Class 3 or 4; or ejection fraction < 45%) Active coronary disease defined as an intervention (e.g., angioplasty, coronary artery bypass surgery) in the prior 6 months Uncontrolled hypertension (BP > 160/100) Clinician diagnosis of any chronic lung disease except asthma Chronic fatigue syndrome or fibromyalgia Self-reported current illicit drug use in the past 30 days Self-reported use of marijuana or opiates in the past 30 days Use of supplemental oxygen Self-reported use of prescribed or over the counter sleeping medications in the past 30 days Current pregnancy or intention of becoming pregnant Oropharyngeal abnormalities (class 2 or class 3 malocclusion) Periodic breathing (Cheyne Stoke respiration) Central sleep apnea (central apnea index (CAI) > 5/h) Investigator discretion Prisoners

Ages Eligible for Study
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Minimum Age: 18 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: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low intensity application of eXciteOSA<br>Participants will receive the eXciteOSA device intervention at low intensity application for 20 minutes per day for 6 consecutive weeks. | Device: eXciteOSA<br>* eXciteOSA is a device for improving genioglossus endurance through electrical stimulation<br>|
| Active Comparator: High intensity application of eXciteOSA<br>Participants will receive the eXciteOSA device intervention at high intensity application for 20 minutes per day for 6 consecutive weeks. | Device: eXciteOSA<br>* eXciteOSA is a device for improving genioglossus endurance through electrical stimulation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Number of Days Device Was Used | Adherence level will be reported as the mean number of days the eXciteOSA device was used. | Up to 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Respiratory Event Index (REI) | The mean respiratory event index (events/hr) will be evaluated using a home sleep apnea test. A higher respiratory event index (REI) indicates greater frequency of abnormal breathing during sleep. | Up to 6 weeks | 
| Epworth Sleepiness Scale (ESS) Scores | Self-reported ESS questionnaire has a total score ranging from 0-24 with the higher score indicating greater daytime sleepiness. | Up to 6 weeks | 
| Pittsburgh Sleep Quality Index (PSQI) | Self-reported PSQI has a total score ranging from (0) to (21) with the higher score indicating worse sleep quality. | Up to 6 weeks | 
| Short Form-20 (SF-20) Scores | Self reported SF-20 has a total score ranging from 0-100 with the higher score indicating better quality of life. | Up to 6 weeks | 
| Quality of Life as Measured by EuroQol Score | Self-reported quality of life based on the EuroQoL has a total score ranging from 0 to 100 with the higher score indicating better quality of life | Up to 6 weeks | 
| Work Productivity and Activity Impairment (WPAI) Questionnaire Scores | Self-reported WPAI questionnaire has a total score ranging from 0-20 the higher score indicating greater impairment daily activities. | Up to 6 weeks | 
| Snoring Visual Analog Scores | Partner reported Snoring visual analog has a total score ranging from 0-100 with the higher score indicating greater degree of snoring. | Up to 6 weeks | 
| Number of Participants Accepting Long Term Treatment | Number of participants reporting acceptance of long term treatment will be reported | 6 weeks |