Obstructive Sleep ApneaSTARTNCT04768543
Stimulation Therapy for Apnea: Reporting Thoughts
An observational study of Obstructive Sleep Apnea, run by University of Pittsburgh at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- Upper airway stimulation (Inspire Medical Systems, Inc.)
- Type of treatment
- Medical device
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Mar 2020to 1 May 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with moderate to severe OSA treated with UAS (Inspire Medical Systems, Maple Grove, Minnesota) who are part of the ADHERE registry.
Who may be able to join
- 18 years of age and older
- ADHERE registry patient
- Received UAS implant from June 2017 to present
Who cannot join
- Patients without up to date contact information
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh
Pittsburgh, Pennsylvania, 15261
About this study
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
- Being tested
- Upper airway stimulation (Inspire Medical Systems, Inc.)
- Keywords
- obstructive sleep apnea, upper airway stimulation therapy
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Upper airway stimulation (Inspire Medical Systems, Inc.)Device
phasic hypoglossal nerve stimulation device
| Study group | Role | What they receive |
|---|---|---|
| Exposure | Patients with moderate to severe OSA treated with UAS (Inspire Medical Systems, Inc) Receives: Device: Upper airway stimulation (Inspire Medical Systems, Inc.) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Experiences with UAS therapy
individual qualitative interview via telephone
Measured: up to 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2021
- Study start2 Mar 2020
- Primary completion1 May 2021
- Study completion1 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- Inspire Medical Systems, Inc.
- Responsible party
- Principal investigator, Faith Luyster, University of Pittsburgh
- Investigators
- Faith Luyster, PhD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04768543
- Sponsor's protocol ID
- STUDY20090150
- Acronym
- START
- Status last verified
- Aug 2022
- First submitted
- 16 Feb 2021
- Last updated
- 10 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
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
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stimulation Therapy for Apnea: Reporting Thoughts
- ClinicalTrials.gov ID
- NCT04768543
- Acronym / sponsor ID
- START / STUDY20090150
- Conditions
- Obstructive Sleep Apnea
- Keywords
- obstructive sleep apnea, upper airway stimulation therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- Inspire Medical Systems, Inc.
- Study start
- 2 Mar 2020 (actual)
- Primary completion
- 1 May 2021 (actual)
- Study completion
- 1 May 2021 (actual)
- First posted
- 24 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Exposure | – | Device: Upper airway stimulation (Inspire Medical Systems, Inc.)Patients with moderate to severe OSA treated with UAS (Inspire Medical Systems, Inc) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with moderate to severe OSA treated with UAS (Inspire Medical Systems, Maple Grove, Minnesota) who are part of the ADHERE registry.
Key inclusion criteria (3 listed)
- 18 years of age and older
- ADHERE registry patient
- Received UAS implant from June 2017 to present
Key exclusion criteria (1 listed)
- Patients without up to date contact information
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Upper airway stimulation (Inspire Medical Systems, Inc.)phasic hypoglossal nerve stimulation device | Device | Exposure |
Primary outcome
Experiences with UAS therapy
Time frame: up to 4 years
individual qualitative interview via telephone
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2022.
- Derived from this study: PubMed 35689597Luyster 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Faith Luyster, PhD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obstructive Sleep Apnea, run by University of Pittsburgh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Experiences with UAS therapy (time frame: up to 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04768543, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2022.