Adherence to Electrical Glossal In Situ Stimulation for Sleep Apnea
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Miami
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Mean Number of Days Device Was Used
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Low intensity application of eXciteOSA
Participants will receive the eXciteOSA device intervention at low intensity application for 20 minutes per day for 6 consecutive weeks.
Intervention: eXciteOSA (Device)
High intensity application of eXciteOSA
Participants will receive the eXciteOSA device intervention at high intensity application for 20 minutes per day for 6 consecutive weeks.
Intervention: eXciteOSA (Device)
Outcomes
Primary Outcomes
Mean Number of Days Device Was Used
Time Frame: Up to 6 weeks
Adherence level will be reported as the mean number of days the eXciteOSA device was used.
Secondary Outcomes
- Quality of Life as Measured by EuroQol Score(Up to 6 weeks)
- Number of Participants Accepting Long Term Treatment(6 weeks)
- Work Productivity and Activity Impairment (WPAI) Questionnaire Scores(Up to 6 weeks)
- Snoring Visual Analog Scores(Up to 6 weeks)
- Epworth Sleepiness Scale (ESS) Scores(Up to 6 weeks)
- Mean Respiratory Event Index (REI)(Up to 6 weeks)
- Pittsburgh Sleep Quality Index (PSQI)(Up to 6 weeks)
- Short Form-20 (SF-20) Scores(Up to 6 weeks)
Investigators
Naresh Punjabi
Professor of Clinical
University of Miami