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

N/AUnknownNCT04191512

Thomas Jefferson University50 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Obstructive Sleep Apnea

Eligibility

Sex: ALLMin age: 22 Years

Medical Language ↔ Plain English

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

Locations (1)

Thomas Jefferson University Department of Otolaryngology

Philadelphia, Pennsylvania, United States

RECRUITING

Outcomes

Primary Outcomes

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

Beth Duddy, RN

CONTACT

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

Data from ClinicalTrials.gov

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