Stimulation Therapy for Apnea: Reporting Thoughts | NCT04768543

Studies
Stimulation Therapy for Apnea: Reporting Thoughts

NCT04768543

Sponsor

University of Pittsburgh

Status

Completed

Last Update Posted

Aug 10, 2022Actual

Enrollment

26Actual

Phase

Not provided

Conditions

Obstructive Sleep Apnea

Interventions

Upper airway stimulation (Inspire Medical Systems, Inc.)

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2, 2020Actual

Primary Completion Date

May 1, 2021Actual

Completion Date

May 1, 2021Actual

First Submitted Date

Feb 16, 2021

First Submission Date that Met QC Criteria

Feb 19, 2021

First Posted Date

Feb 24, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 9, 2022

Last Update Posted Date

Aug 10, 2022Actual

Name	Class
Inspire Medical Systems, Inc.	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

26Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Exposure		Patients with moderate to severe OSA treated with UAS (Inspire Medical Systems, Inc)	Device: Upper airway stimulation (Inspire Medical Systems, Inc.)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Upper airway stimulation (Inspire Medical Systems, Inc.)	Device	phasic hypoglossal nerve stimulation device	Exposure

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Experiences with UAS therapy	individual qualitative interview via telephone	up to 4 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder 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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Faith Luyster, PhD	University of Pittsburgh	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Pittsburgh		Pittsburgh	Pennsylvania	15261	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
35689597	Derived	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.

ID	Term
D012891	Sleep Apnea Syndromes
D001049	Apnea
D012120	Respiration Disorders
D012140	Respiratory Tract Diseases