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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04191512

Enrollment

Registered

2019-12-09

Start date

2019-11-19

Completion date

2025-10-21

Last updated

2024-04-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obstructive Sleep Apnea

Keywords

Obstructive Sleep Apnea, Continuous Positive Airway Pressure

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

22 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Difference in polysomnography (PSG) data between UAS and CPAP groups	2 years
Difference in Epworth Sleepiness Scale questionnaire data between UAS and CPAP groups	2 years
Difference in Functional Outcomes of Sleep questionnaire data between UAS and CPAP groups	2 years

Countries

United States

Contacts

Primary ContactBeth Duddy, RN

elizabeth.duddy@jefferson.edu215-955-9880

Outcome results