Clinical trial NCT04974515: Adherence to Electrical Glossal In Situ Stimulation for Sleep Apnea (AEGIS Study)
Official title: Adherence to Electrical Glossal In Situ Stimulation for Sleep Apnea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Sleep Apnea
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2021-07-23
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility criteria: Inclusion Criteria:

1. Age greater than 18 years
2. Ability to consent
3. Home sleep apnea test demonstrating mild obstructive sleep apnea.
4. Smartphone or tablet

Exclusion Criteria:

1. Current pacemaker, defibrillator, or neuro-stimulation device
2. No prior oropharyngeal surgery for sleep apnea
3. No implants, metal prostheses, dental braces, or soft tissue/bony ulcerations in the oral cavity
4. No prior use of mandibular advancement device (MAD) or continuous positive airway pressure (CPAP)
5. Heart failure (New York Heart Association Class 3 or 4; or ejection fraction \< 45%)
6. Active coronary disease defined as an intervention (e.g., angioplasty, coronary artery bypass surgery) in the prior 6 months
7. Uncontrolled hypertension (BP \> 160/100)
8. Clinician diagnosis of any chronic lung disease except asthma
9. Chronic fatigue syndrome or fibromyalgia
10. Self-reported current illicit drug use in the past 30 days
11. Self-reported use of marijuana or opiates in the past 30 days
12. Use of supplemental oxygen
13. Self-reported use of prescribed or over the counter sleeping medications in the past 30 days
14. Current pregnancy or intention of becoming pregnant
15. Oropharyngeal abnormalities (class 2 or class 3 malocclusion)
16. Periodic breathing (Cheyne Stoke respiration)
17. Central sleep apnea (central apnea index (CAI) \> 5/h)
18. Investigator discretion
19. Prisoners

Primary outcomes:
measure: Mean Number of Days Device Was Used
timeFrame: Up to 6 weeks
Secondary outcomes:
measure: Mean Respiratory Event Index (REI)
timeFrame: Up to 6 weeks
measure: Epworth Sleepiness Scale (ESS) Scores
timeFrame: Up to 6 weeks
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Up to 6 weeks
measure: Short Form-20 (SF-20) Scores
timeFrame: Up to 6 weeks
measure: Quality of Life as Measured by EuroQol Score
timeFrame: Up to 6 weeks
measure: Work Productivity and Activity Impairment (WPAI) Questionnaire Scores
timeFrame: Up to 6 weeks
measure: Snoring Visual Analog Scores
timeFrame: Up to 6 weeks
measure: Number of Participants Accepting Long Term Treatment
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami
state: Florida
Study officials:
affiliation: University of Miami
name: Naresh Punjabi, MD
role: PRINCIPAL_INVESTIGATOR
References: