Stimulation Therapy for Apnea: Reporting Thoughts

NCT ID: NCT04768543

Last Updated: 2022-08-10

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

COMPLETED

Total Enrollment

26 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-03-02

Study Completion Date

2021-05-01

Brief Summary

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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.

Detailed Description

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Conditions

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Obstructive Sleep Apnea

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Exposure

Patients with moderate to severe OSA treated with UAS (Inspire Medical Systems, Inc)

Upper airway stimulation (Inspire Medical Systems, Inc.)

Intervention Type DEVICE

phasic hypoglossal nerve stimulation device

Interventions

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Upper airway stimulation (Inspire Medical Systems, Inc.)

phasic hypoglossal nerve stimulation device

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Inspire Medical Systems, Inc.

INDUSTRY

Sponsor Role collaborator

University of Pittsburgh

OTHER

Sponsor Role lead

Responsible Party

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Faith Luyster

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Faith Luyster, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

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University of Pittsburgh

Pittsburgh, Pennsylvania, United States

Site Status

Countries

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United States

References

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Luyster FS, Ni Q, Lee K, Harrison C, Ramprasad VH, Soose RJ, Strollo PJ. Factors affecting obstructive sleep apnea patients' use of upper airway stimulation treatment. J Clin Sleep Med. 2022 Sep 1;18(9):2207-2215. doi: 10.5664/jcsm.10086.

Reference Type DERIVED
PMID: 35689597 (View on PubMed)

Other Identifiers

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STUDY20090150

Identifier Type: -

Identifier Source: org_study_id

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