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)

NCT ID: NCT04416542

Last Updated: 2022-06-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-28
• Study Completion Date: 2022-06-10

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.

Conditions

Obstructive Sleep Apnea

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Control

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Home Monitoring

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

Group Type: ACTIVE_COMPARATOR

Home Sleep Testing

Intervention Type: 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.

Interventions

Home Sleep Testing

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.

Intervention Type: DIAGNOSTIC_TEST

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.

• Minimum Eligible Age: 22 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Inspire Medical Systems, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 37421320 (View on PubMed)

Other Identifiers

2020-001

Identifier Type: -

Identifier Source: org_study_id