N/A
Completed N=40
Adherence to Electrical Glossal In Situ Stimulation for Sleep Apnea (AEGIS Study)
Source: ClinicalTrials.gov NCT04974515 ↗Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Oct 2023
Primary outcomePrimary: Mean Number of Days Device Was Used — 38.0; 38.4 Days
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Number of Days Device Was Used |
38.0; 38.4 | — |
| SECONDARY Mean Respiratory Event Index (REI) |
12.6; 9.6 | — |
| SECONDARY Epworth Sleepiness Scale (ESS) Scores |
9.4; 6.9 | — |
| SECONDARY Pittsburgh Sleep Quality Index (PSQI) |
7.2; 5.5 | — |
| SECONDARY Short Form-20 (SF-20) Scores |
76.6; 86.5 | — |
| SECONDARY Quality of Life as Measured by EuroQol Score |
0.88; 0.84 | — |
| SECONDARY Work Productivity and Activity Impairment (WPAI) Questionnaire Scores |
1.0; 9.5 | — |
| SECONDARY Snoring Visual Analog Scores |
50.3; 42.5 | — |
| SECONDARY Number of Participants Accepting Long Term Treatment |
0; 0 | — |
Eligibility Criteria
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 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
Data sourced from ClinicalTrials.gov (NCT04974515). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.