Recruiting

Upper Airway Stimulation vs. CPAP

Sponsor:

Thomas Jefferson University

Code:

NCT04191512

Conditions

Obstructive Sleep Apnea

Eligibility Criteria

Sex: All

Age: 22+

Healthy Volunteers: Not accepted

Study Details

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.

Conditions

Obstructive Sleep Apnea

Study ID

NCT04191512

Start date

Nov 19, 2019

Status verified date

Apr, 2024

Completion date

Oct 21, 2025

Anticipated

Primary completion date

Jan 21, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 22+

Healthy Volunteers: Not accepted

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

Enrollment

50 participants

Anticipated

Interventions and Outcome Measures

Arms

Upper airway stimulation

Continuous positive airway pressure

Primary outcome measure

  • Difference in polysomnography (PSG) data between UAS and CPAP groups [ Time Frame: 2 years ]
  • Difference in Epworth Sleepiness Scale questionnaire data between UAS and CPAP groups [ Time Frame: 2 years ]
  • Difference in Functional Outcomes of Sleep questionnaire data between UAS and CPAP groups [ Time Frame: 2 years ]

Central Contacts and Locations

Central contacts

Beth Duddy, RN

215-955-9880elizabeth.duddy@jefferson.edu

Locations

Thomas Jefferson University Department of Otolaryngology

Recruiting

Philadelphia, Pennsylvania, United States, 19107

Principal Investigator:

Colin Huntley, MD

More Information

Sponsor

Thomas Jefferson University

Last update posted

Apr 22, 2024

Last verified

Apr, 2024

Keywords

  • Obstructive Sleep Apnea
  • Continuous Positive Airway Pressure

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Thomas Jefferson University on 2024-04-22.