ClinicalTrials.gg
CompletedNCT04768543STARTUpdated Aug 10, 2022

Stimulation Therapy for Apnea: Reporting Thoughts

An observational study in Obstructive Sleep Apnea, sponsored by University of Pittsburgh. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-08-10.

Sponsored by University of Pittsburgh · Observational

Study type
Observational
Model
Case-only
Time perspective
Cross-sectional
Enrollment
26
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Obstructive Sleep Apnea

Keywords

  • obstructive sleep apnea
  • upper airway stimulation therapy
03

In context

Sleep Apnea, Obstructive

2,263 studies on the registry are indexed under Sleep Apnea, Obstructive; 465 are open to participants now.

This study's enrollment of 26 is below the median of 105 across 666 observational studies indexed under Sleep Apnea, Obstructive.

Browse Sleep Apnea, Obstructive studies →

Lead sponsor

University of Pittsburgh is the lead sponsor of 1,414 studies on the registry; 168 are open to participants now.

Of its 8 completed or terminated interventional studies of FDA-regulated products, 4 (50%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Patients without up to date contact information
05

Study design

Observational model
Case-only
Time perspective
Cross-sectional
Enrollment
26 participants (actual)
Patient registry
No

Groups and cohorts

  • Exposure

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

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

Interventions

  • DeviceUpper airway stimulation (Inspire Medical Systems, Inc.)

    phasic hypoglossal nerve stimulation device

06

What researchers measure

Primary outcomes

  1. Experiences with UAS therapy

    individual qualitative interview via telephone

    Time frame: up to 4 years

07

Study locations

1 site
  • University of Pittsburgh
    Pittsburgh, Pennsylvania 15261, United States
08

References and documents

Publications

  • 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. PubMed 35689597 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 10, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04768543
Collaborators
Inspire Medical Systems, Inc.
Responsible party
Faith Luyster (Assistant Professor, University of Pittsburgh) — Principal investigator
First posted
Feb 24, 2021
Start date
Mar 2, 2020
Primary completion
May 1, 2021
Completion
May 1, 2021
Last update
Aug 10, 2022

Study contacts

Faith Luyster, PhD
principal investigator · University of Pittsburgh

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion