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Clinical Trials/NCT04191512
NCT04191512RecruitingNot Applicable

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

Thomas Jefferson University2 sites in 1 country50 target enrollmentStarted: November 19, 2019Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
50
Locations
2
Primary Endpoint
Difference in polysomnography (PSG) data between UAS and CPAP groups
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
22 Years to — (Adult, Older Adult)
Sex
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

  • Not provided

Arms & Interventions

Upper airway stimulation

Continuous positive airway pressure

Outcomes

Primary Outcomes

Difference in polysomnography (PSG) 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

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

Time Frame: 2 years

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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