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Completed

NCT Number: 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)

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

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Key information

Conditions

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

Age range

22 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Indiana University School of Medicine, Indianapolis, Indiana, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

Primary outcomes

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

    Time frame: 6 months post-activation

    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.

Secondary outcomes

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

    Time frame: 6 months post-activation

    The Epworth Sleepiness Scale (ESS) endpoint will be determined by performing an equivalence test for the ESS score at 6 months between the control group and the home monitoring group. The objective is to demonstrate ESS score to be equivalent between the two groups.

    H0: |x ̃_diff |>2 Ha: |x ̃_diff |≤2

    where x ̃_diff is the median of differences (location shift) in the ESS score between the two groups.

    As the ESS score at 6 months has been shown to be non-normally distributed in previous studies, a non-parametric Hodges-Lehmann test at a significance level of 0.05 will be used to determine the location shift and its confidence interval between the two groups. An equivalence margin between -2 and 2 will be used as this is the defined meaningful clinical difference based on the AASM guidelines8.

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

    Time frame: 6 months post-activation

    The Oxygen Desaturation Index (ODI) endpoint will be determined by performing an equivalence test for the ODI score at 6 months between the control group and the home monitoring group. The objective is to demonstrate ODI score to be equivalent between the two groups.

    H0: |x ̃_diff |>15 Ha: |x ̃_diff |≤15 where x ̃_diff is the median of differences (location shift) in the ODI score between the two groups.

    As the ODI score at 6 months has been shown to be non-normally distributed in previous studies, a non-parametric Hodges-Lehmann test at a significance level of 0.05 will be used to determine the location shift and its confidence interval between the two groups. ODI is closely related to AHI and therefore an equivalence margin of -15 and 15 will be used.

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

    Time frame: 6 months post-activation

    The therapy usage endpoint will be determined by performing an equivalence test for the average therapy usage at 6 months between the control group and the home monitoring group. The objective is to demonstrate therapy usage to be equivalent between the two groups.

    H0: |x ̃_diff |>0.5 hrs Ha: |x ̃_diff |≤0.5 hrs where x ̃_diff is the median of differences (location shift) in therapy usage between the two groups.

    As the treatment therapy usage at 6 months has been shown to be non-normally distributed in previous studies, a non-parametric Hodges-Lehmann test at a significance level of 0.05 will be used to determine the location shift and its confidence interval between the two groups. An equivalence margin between -0.5 and 0.5 hrs will be used as this is the defined meaningful clinical difference based on the AASM guidelines8.

Sponsors and collaborators

Lead sponsor

Inspire Medical Systems, Inc.

Industry

Registry information

Acronym: HOME

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jun 4, 2020
Registry last updated
Jun 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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