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

NCT ID: NCT04191512

Last Updated: 2024-04-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-11-19

Study Completion Date

2025-10-21

Brief Summary

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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.

Detailed Description

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Conditions

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Obstructive Sleep Apnea

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Upper airway stimulation

No interventions assigned to this group

Continuous positive airway pressure

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

22 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Thomas Jefferson University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Thomas Jefferson University Department of Otolaryngology

Philadelphia, Pennsylvania, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Beth Duddy, RN

Role: CONTACT

215-955-9880

Facility Contacts

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Elizabeth Duddy, RN, BSN

Role: primary

Other Identifiers

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19C.245

Identifier Type: -

Identifier Source: org_study_id

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