Stimulation Therapy for Apnea: Reporting Thoughts

NCT04768543 | Completed FDA Device

• 1 other identifier: STUDY20090150
• Study Type: observational
• Target: 26
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Obstructive Sleep Apnea

Keywords

obstructive sleep apnea; upper airway stimulation therapy

Outcome Measures

Primary Outcomes (1)

• Experiences with UAS therapy

  individual qualitative interview via telephone

  up to 4 years

Study Arms (1)

Exposure

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

Device: Upper airway stimulation (Inspire Medical Systems, Inc.)

Interventions

Upper airway stimulation (Inspire Medical Systems, Inc.) DEVICE

phasic hypoglossal nerve stimulation device

Exposure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with moderate to severe OSA treated with UAS (Inspire Medical Systems, Maple Grove, Minnesota) who are part of the ADHERE registry.

You may qualify if:

• years of age and older
• ADHERE registry patient
• Received UAS implant from June 2017 to present

You may not qualify if:

• Patients without up to date contact information

Sponsors & Collaborators

• University of Pittsburgh: lead
• Inspire Medical Systems, Inc.: collaborator

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15261, United States

Location

Related Publications (1)

• 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.

  PMID: 35689597 DERIVED

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Faith Luyster, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 16, 2021
• First Posted: February 24, 2021
• Study Start: March 2, 2020
• Primary Completion: May 1, 2021
• Study Completion: May 1, 2021
• Last Updated: August 10, 2022

Record last verified: 2022-08

Locations

US (1)