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Stimulation Therapy for Apnea: Reporting Thoughts

Stimulation Therapy for Apnea: Reporting Thoughts

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04768543
Acronym
START
Enrollment
26
Registered
2021-02-24
Start date
2020-03-02
Completion date
2021-05-01
Last updated
2022-08-10

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, upper airway stimulation therapy

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.

Interventions

DEVICEUpper airway stimulation (Inspire Medical Systems, Inc.)

phasic hypoglossal nerve stimulation device

Sponsors

Inspire Medical Systems, Inc.
CollaboratorINDUSTRY
University of Pittsburgh
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Experiences with UAS therapyup to 4 yearsindividual qualitative interview via telephone

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 13, 2026