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NCT04191512 Clinical Trial

Head to Head Comparison of Upper Airway Stimulation and Continuous Positive Airway Pressure; a Pilot Study.

Obstructive Sleep Apnea Clinical Trial

Official title:
Head to Head Comparison of Upper Airway Stimulation and Continuous Positive Airway Pressure; a Pilot Study.

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04191512
Other study ID # 19C.245
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date November 19, 2019
Est. completion date October 21, 2025

Study information
Verified date April 2024
Source Thomas Jefferson University
Contact Beth Duddy, RN
Phone 215-955-9880
Email elizabeth.duddy@jefferson.edu
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 50
Est. completion date October 21, 2025
Est. primary completion date January 21, 2025
Accepts healthy volunteers No
Gender All
Age group 22 Years and older
Eligibility 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

Related Conditions & MeSH terms

Locations
Country Name City State
United States Thomas Jefferson University Department of Otolaryngology Philadelphia Pennsylvania

Sponsors (1)
Lead Sponsor Collaborator
Thomas Jefferson University

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Difference in polysomnography (PSG) data between UAS and CPAP groups 2 years
Primary Difference in Epworth Sleepiness Scale questionnaire data between UAS and CPAP groups 2 years
Primary Difference in Functional Outcomes of Sleep questionnaire data between UAS and CPAP groups 2 years
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