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

Sponsor
Thomas Jefferson University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04191512
Collaborator
(none)
50
Enrollment
1
Location
47
Anticipated Duration (Months)
1.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    50 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Head to Head Comparison of Upper Airway Stimulation and Continuous Positive Airway Pressure; a Pilot Study.
    Actual Study Start Date :
    Nov 19, 2019
    Anticipated Primary Completion Date :
    Oct 21, 2022
    Anticipated Study Completion Date :
    Oct 21, 2023

    Arms and Interventions

    Arm Intervention/Treatment
    Upper airway stimulation
    Continuous positive airway pressure

    Outcome Measures

    Primary Outcome Measures

    1. Difference in polysomnography (PSG) data between UAS and CPAP groups [2 years]

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

    3. Difference in Functional Outcomes of Sleep questionnaire data between UAS and CPAP groups [2 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    22 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Thomas Jefferson University Department of Otolaryngology Philadelphia Pennsylvania United States 19107

    Sponsors and Collaborators

    • Thomas Jefferson University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Thomas Jefferson University
    ClinicalTrials.gov Identifier:
    NCT04191512
    Other Study ID Numbers:
    • 19C.245
    First Posted:
    Dec 9, 2019
    Last Update Posted:
    Apr 6, 2021
    Last Verified:
    Apr 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by Thomas Jefferson University
    Obstructive Sleep Apnea
    Continuous Positive Airway Pressure
    Additional relevant MeSH terms:
    Sleep Apnea Syndromes
    Sleep Apnea, Obstructive

    Study Results

    No Results Posted as of Apr 6, 2021