Comparing Upper Airway Stimulation and CPAP for Sleep Apnea
Head to Head Comparison of Upper Airway Stimulation and Continuous Positive Airway Pressure; a Pilot Study.
Thomas Jefferson University · NCT04191512
This study is testing whether a new treatment called Upper Airway Stimulation works better than the standard CPAP machine for people with obstructive sleep apnea.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 22 Years and up |
| Sex | All |
| Sponsor | Thomas Jefferson University (other) |
| Locations | 1 site (Philadelphia, Pennsylvania) |
| Trial ID | NCT04191512 on ClinicalTrials.gov |
What this trial studies
This study aims to compare the effectiveness of Upper Airway Stimulation (UAS) and Continuous Positive Airway Pressure (CPAP) in treating patients with obstructive sleep apnea (OSA). It will utilize a full night polysomnographic evaluation to assess the outcomes of both treatments in a pilot cohort. Participants will either have undergone UAS implantation or have successfully tolerated CPAP therapy. The goal is to provide a direct comparison of these two treatment modalities for OSA.
Who should consider this trial
Good fit: Ideal candidates are adults over 22 years old with a history of moderate to severe obstructive sleep apnea who have either undergone UAS implantation or can tolerate CPAP.
Not a fit: Patients with mild obstructive sleep apnea or those who have not undergone UAS implantation or cannot tolerate CPAP may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help identify the more effective treatment option for patients with obstructive sleep apnea.
How similar studies have performed: While there have been studies on UAS and CPAP separately, this head-to-head comparison is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Philadelphia, Pennsylvania
- Thomas Jefferson University Department of Otolaryngology — Philadelphia, Pennsylvania, United States (RECRUITING)
Study contacts
- Study coordinator: Beth Duddy, RN
- Email: elizabeth.duddy@jefferson.edu
- Phone: 215-955-9880
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Obstructive Sleep Apnea, Continuous Positive Airway Pressure