Inspire Home Study: Utilization of Home Monitoring During Therapy Optimization in Patients With an Inspire Upper Airway Stimulation System (Comparison of Home Sleep Testing vs. In-lab Polysomnography Testing)

Completed · Not applicable

Conditions studied: Obstructive Sleep Apnea

In brief

Inspire intends to conduct this study to compare Apnea-Hypopnea Index (AHI), between the two randomization arms, at 6 months post-activation

Key facts

Study ID

NCT04416542

Run by

Inspire Medical Systems, Inc.

People needed

64

Starts

2020-07-28

Expected to finish

2022-06-10

Last updated by the study team

2022-06-21

Who can join

Age: 22 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Patient is ≥ 22 years of age;
• Patient has been diagnosed with moderate to severe OSA, with a baseline (pre-implant) AHI ≥ 15 based on a qualified sleep study;
• Patient has been implanted with the Inspire UAS System but not yet activated, or has been scheduled for implant of the Inspire UAS System;
• Patient currently owns a SmartPhone and is willing and able to install and use SmartPhone apps (at no cost to patient);
• Patient is willing to utilize study equipment at home including Home Sleep Test (HST) equipment, pulse oximetry equipment, and sleep tracking equipment in accordance with the study protocol;
• Patient is willing and able to return for all follow-up study visits;
• Patient is willing to be randomized and adhere to randomization allocation;
• Patient is willing to and capable of providing informed consent.

You may not qualify if…

• Patient has central + mixed apneas more than > 25% of the total AHI;
• Patient currently uses adjunctive sleep therapy (eg. CPAP, oral appliance, positional therapy) and will not discontinue use of adjunctive therapy upon implant of the Inspire UAS System;
• Patient is pregnant or plans to become pregnant;
• Patient has a terminal illness with life expectancy < 12 months;
• Any other reason the investigator deems that the patient is unfit for participation in the study.

Where it is running

• Indiana University School of Medicine — Indianapolis, Indiana, United States
• Massachusetts Eye and Ear Infirmary — Boston, Massachusetts, United States
• Cleveland Clinic Foundation — Cleveland, Ohio, United States
• Ohio Sleep Medicine Institute — Dublin, Ohio, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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