Head to Head Comparison of Upper Airway Stimulation and Continuous Positive Airway Pressure; a Pilot Study.
Recruiting
- Conditions
- Obstructive Sleep Apnea
- Registration Number
- NCT04191512
- Lead Sponsor
- Thomas Jefferson University
- Brief Summary
To date, there has been no head to head comparison of Upper Airway Stimulation (UAS) and Continuous Positive Airway Pressure (CPAP) utilizing a full night polysomnographic evaluation. With this study we aim to evaluate a pilot cohort of patients with OSA treated with CPAP or UAS using the WatchPAT polysomnography system.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 50
Inclusion Criteria
- Age greater than 22 years old
- History of moderate to severe OSA (AHI 15-65)
- UAS implantation with postoperative titration and demonstrated successful use of therapy or has demonstrated the ability to tolerate CPAP for greater than 4 hours per night 5 days per week.
Exclusion Criteria
- none
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Difference in polysomnography (PSG) data between UAS and CPAP groups 2 years Difference in Functional Outcomes of Sleep questionnaire data between UAS and CPAP groups 2 years Difference in Epworth Sleepiness Scale questionnaire data between UAS and CPAP groups 2 years
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Thomas Jefferson University Department of Otolaryngology
🇺🇸Philadelphia, Pennsylvania, United States