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NCT04768543 Clinical Trial

Stimulation Therapy for Apnea: Reporting Thoughts

Obstructive Sleep Apnea Clinical Trial

— START  

Official title:
Stimulation Therapy for Apnea: Reporting Thoughts

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04768543
Other study ID # STUDY20090150
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 2, 2020
Est. completion date May 1, 2021

Study information
Verified date August 2022
Source University of Pittsburgh
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Upper airway stimulation (UAS) via unilateral implantation of a phasic hypoglossal nerve stimulation device is a safe and effective alternative treatment for patients with moderate to severe obstructive sleep apnea (OSA) who are unwilling or unable to adhere to positive airway pressure (PAP) therapy. Although adherence to UAS is higher than to PAP, there remain patients who are not using UAS consistently. The aim of this project is to explore critical factors in the use of UAS by OSA patients using qualitative research methods (personal interviews). The proposed study will provide crucial information about patients' concerns regarding UAS use and suggestions for how to support new UAS recipients.

Recruitment information / eligibility
Status Completed
Enrollment 26
Est. completion date May 1, 2021
Est. primary completion date May 1, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 18 years of age and older - ADHERE registry patient - Received UAS implant from June 2017 to present Exclusion Criteria: - Patients without up to date contact information

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Upper airway stimulation (Inspire Medical Systems, Inc.)
phasic hypoglossal nerve stimulation device

Locations
Country Name City State
United States University of Pittsburgh Pittsburgh Pennsylvania

Sponsors (2)
Lead Sponsor Collaborator
University of Pittsburgh Inspire Medical Systems, Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Experiences with UAS therapy individual qualitative interview via telephone up to 4 years
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