Clinical trial NCT04416542: 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)
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Sleep Apnea
Keywords: OSA
Lead sponsor: Inspire Medical Systems, Inc.
Sponsor class: INDUSTRY
First posted: 2020-06-04
Enrollment: 64
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed description: This study is a prospective, randomized, non-blinded, multi-center study of therapy optimization related to the Inspire UAS System (implanted in a commercial setting under current labeling).

Comparison of outcomes between two (2) groups of patients (both implanted with the Inspire UAS system) who undergo different post-implant care algorithms throughout follow-up, in order to determine whether home sleep monitoring may be used as a surrogate for an in-lab PSG titration in a sub-set of patients.

Subjects who have been identified as candidates for Inspire therapy (implant of the Inspire UAS system), according to commercial labeling, will be recruited to participate in the study.

A maximum of 100 subjects will be enrolled at up to 5 clinical centers. A total of 60 subjects will be randomized (1:1) to one of two study arms.

Eligibility criteria: Inclusion Criteria:

1. Patient is ≥ 22 years of age;
2. Patient has been diagnosed with moderate to severe OSA, with a baseline (pre-implant) AHI ≥ 15 based on a qualified sleep study;
3. Patient has been implanted with the Inspire UAS System but not yet activated, or has been scheduled for implant of the Inspire UAS System;
4. Patient currently owns a SmartPhone and is willing and able to install and use SmartPhone apps (at no cost to patient);
5. 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;
6. Patient is willing and able to return for all follow-up study visits;
7. Patient is willing to be randomized and adhere to randomization allocation;
8. Patient is willing to and capable of providing informed consent.

Exclusion Criteria:

1. Patient has central + mixed apneas more than \> 25% of the total AHI;
2. 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;
3. Patient is pregnant or plans to become pregnant;
4. Patient has a terminal illness with life expectancy \< 12 months;
5. Any other reason the investigator deems that the patient is unfit for participation in the study.

Primary outcomes:
measure: Comparison of Apnea-Hypopnea Index (AHI), between the two randomization arms
timeFrame: 6 months post-activation
Secondary outcomes:
measure: Comparison of Epworth Sleepiness Scale (ESS), between the two randomization arms
timeFrame: 6 months post-activation
measure: Comparison of Oxygen Desaturation Index (ODI), between the two randomization arms
timeFrame: 6 months post-activation
measure: Comparison of Therapy Usage (hours per week), between the two randomization arms
timeFrame: 6 months post-activation
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University School of Medicine
state: Indiana
city: Boston
country: United States
facility: Massachusetts Eye and Ear Infirmary
state: Massachusetts
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Dublin
country: United States
facility: Ohio Sleep Medicine Institute
state: Ohio
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
References: