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

Not Applicable

Completed

Brief Summary: 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.

Recruitment & Eligibility

Inclusion Criteria

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

Arm && Interventions

Group	Intervention	Description
Low intensity application of eXciteOSA	eXciteOSA	Participants will receive the eXciteOSA device intervention at low intensity application for 20 minutes per day for 6 consecutive weeks.
High intensity application of eXciteOSA	eXciteOSA	Participants will receive the eXciteOSA device intervention at high intensity application for 20 minutes per day for 6 consecutive weeks.

Primary Outcome Measures

Name	Time	Method
Mean Number of Days Device Was Used	Up to 6 weeks	Adherence level will be reported as the mean number of days the eXciteOSA device was used.

Secondary Outcome Measures

Name	Time	Method
Work Productivity and Activity Impairment (WPAI) Questionnaire Scores	Up to 6 weeks	Self-reported WPAI questionnaire has a total score ranging from 0-20 the higher score indicating greater impairment daily activities.
Snoring Visual Analog Scores	Up to 6 weeks	Partner reported Snoring visual analog has a total score ranging from 0-100 with the higher score indicating greater degree of snoring.
Epworth Sleepiness Scale (ESS) Scores	Up to 6 weeks	Self-reported ESS questionnaire has a total score ranging from 0-24 with the higher score indicating greater daytime sleepiness.
Quality of Life as Measured by EuroQol Score	Up to 6 weeks	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
Number of Participants Accepting Long Term Treatment	6 weeks	Number of participants reporting acceptance of long term treatment will be reported
Mean Respiratory Event Index (REI)	Up to 6 weeks	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.
Pittsburgh Sleep Quality Index (PSQI)	Up to 6 weeks	Self-reported PSQI has a total score ranging from (0) to (21) with the higher score indicating worse sleep quality.
Short Form-20 (SF-20) Scores	Up to 6 weeks	Self reported SF-20 has a total score ranging from 0-100 with the higher score indicating better quality of life.