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)

NCT04416542 | Completed FDA Device

• 1 other identifier: 2020-001
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 5

Brief Summary

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

Conditions

Obstructive Sleep Apnea

Keywords

OSA

Outcome Measures

Primary Outcomes (1)

• Comparison of Apnea-Hypopnea Index (AHI), between the two randomization arms

  The AHI endpoint will be determined by performing three equivalency tests for the following: Absolute AHI and, change in AHI. All comparisons will be done on the treatment AHI at 6 months between the control group and the home monitoring group. The objective is to demonstrate the equivalence in AHI, change in AHI, and response rate between the two groups.

  6 months post-activation

Secondary Outcomes (3)

• Comparison of Epworth Sleepiness Scale (ESS), between the two randomization arms

  6 months post-activation

• Comparison of Oxygen Desaturation Index (ODI), between the two randomization arms

  6 months post-activation

• Comparison of Therapy Usage (hours per week), between the two randomization arms

  6 months post-activation

Study Arms (2)

Control

NO INTERVENTION

Subjects in this group will be implanted with the Inspire UAS system and will undergo a standard in-lab PSG titration study at approximately 3 months post-activation and a 2-night HST at approximately 6 months post-activation

Home Monitoring

ACTIVE COMPARATOR

Subjects who have undergone implant of the Inspire UAS System and are randomized to this group will undergo a 2-night HST at 3 months post-activation. Depending on the results of the 2-night HST, the subject will either (a) undergo a PSG titration at 5 months post-activation and a 2-night HST at 6 months post-activation OR (b) undergo only a 2-night HST at approximately 6 months post-activation

Diagnostic Test: Home Sleep Testing

Interventions

Home Sleep Testing DIAGNOSTIC_TEST

Two-night Home Sleep Tests (HSTs) will be conducted using commercially available Home Sleep Test equipment. The HST will be ordered by the clinical center through a HIPAA compliant HST service that has been selected by the study sponsor. The HSTs will be scored and interpreted according to AASM Guidelines by board certified sleep physicians affiliated with the HST service. The HST will be scored using the 4% oxygen desaturation rule.

Home Monitoring

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Inspire Medical Systems, Inc.: lead

Study Sites (5)

Indiana University School of Medicine

Indianapolis, Indiana, 46202, United States

Location

Massachusetts Eye and Ear Infirmary

Boston, Massachusetts, 02115, United States

Location

Cleveland Clinic Foundation

Cleveland, Ohio, 44104, United States

Location

Ohio Sleep Medicine Institute

Dublin, Ohio, 43107, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Related Publications (1)

• Kent D, Huyett P, Yu P, Roy A, Mehra R, Rundo JV, Stahl S, Manchanda S. Comparison of clinical pathways for hypoglossal nerve stimulation management: in-laboratory titration polysomnography vs home-based efficacy sleep testing. J Clin Sleep Med. 2023 Nov 1;19(11):1905-1912. doi: 10.5664/jcsm.10712.

  PMID: 37421320 DERIVED

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2020
• First Posted: June 4, 2020
• Study Start: July 28, 2020
• Primary Completion: June 10, 2022
• Study Completion: June 10, 2022
• Last Updated: June 21, 2022

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)