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RecruitingNCT04191512Updated Sep 29, 2026

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

An observational study in Obstructive Sleep Apnea, sponsored by Thomas Jefferson University. Recruiting at 1 site in United States. Open to participants aged 22 Years and older. Per ClinicalTrials.gov, last updated 2026-09-29.

Sponsored by Thomas Jefferson University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
50
Ages
22 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Obstructive Sleep Apnea

Keywords

  • Obstructive Sleep Apnea
  • Continuous Positive Airway Pressure
03

Who can participate

Ages eligible
22 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Patients using upper airway stimulation or continuous positive airway pressure

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

Exclusion Criteria:

  • none
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
50 participants (estimated)
Patient registry
No

Groups and cohorts

  • Upper airway stimulation
  • Continuous positive airway pressure
05

What researchers measure

Primary outcomes

  1. Difference in polysomnography (PSG) data between UAS and CPAP groups

    Time frame: 2 years

  2. Difference in Epworth Sleepiness Scale questionnaire data between UAS and CPAP groups

    Time frame: 2 years

  3. Difference in Functional Outcomes of Sleep questionnaire data between UAS and CPAP groups

    Time frame: 2 years

06

Study locations

1 of 1 sites recruiting
  • Thomas Jefferson University Department of Otolaryngology
    Philadelphia, Pennsylvania 19107, United States
    • Elizabeth Duddy, RN, BSN · Contact
    • Colin Huntley, MD · Principal investigator
    Recruiting
07

Registry details

Key details

Study ID
NCT04191512
Lead sponsor
Thomas Jefferson University
Responsible party
Sponsor
First posted
Dec 9, 2019
Start date
Nov 19, 2019
Primary completion
Jun 30, 2027 (estimated)
Completion
Jun 30, 2027 (estimated)
Last update
Sep 29, 2026

Study contacts

Beth Duddy, RN
Contact
elizabeth.duddy@jefferson.edu
215-955-9880

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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