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OpenTrials
Completed

NCT Number: NCT04768543

Stimulation Therapy for Apnea: Reporting Thoughts

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15261, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Upper airway stimulation (Inspire Medical Systems, Inc.)

Device

phasic hypoglossal nerve stimulation device

Primary outcomes

  1. Experiences with UAS therapy

    Time frame: up to 4 years

    individual qualitative interview via telephone

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Collaborators

  • Inspire Medical Systems, Inc.

Registry information

Acronym: START

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Feb 24, 2021
Registry last updated
Aug 10, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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