Back to resultsInspire 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) (HOME)
Primary Purpose
Obstructive Sleep Apnea
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Home Sleep Testing
Sponsored by
About this trial
This is an interventional treatment trial for Obstructive Sleep Apnea focused on measuring OSA
Eligibility Criteria
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.
Sites / Locations
- Indiana University School of Medicine
- Massachusetts Eye and Ear Infirmary
- Cleveland Clinic Foundation
- Ohio Sleep Medicine Institute
- Vanderbilt University Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Active Comparator
Arm Label
Control
Home Monitoring
Arm Description
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
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
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Comparison of Epworth Sleepiness Scale (ESS), between the two randomization arms
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.
Comparison of Oxygen Desaturation Index (ODI), between the two randomization arms
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.
Comparison of Therapy Usage (hours per week), between the two randomization arms
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.
Full Information
NCT ID
NCT04416542
First Posted
June 1, 2020
Last Updated
June 15, 2022
Sponsor
Inspire Medical Systems, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT04416542
Brief 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)
Acronym
HOME
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
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
July 28, 2020 (Actual)
Primary Completion Date
June 10, 2022 (Actual)
Study Completion Date
June 10, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Inspire Medical Systems, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea
Keywords
OSA
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
64 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
No Intervention
Arm Description
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
Arm Title
Home Monitoring
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Diagnostic Test
Intervention Name(s)
Home Sleep Testing
Intervention Description
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 Outcome Measure Information:
Title
Comparison of Apnea-Hypopnea Index (AHI), between the two randomization arms
Description
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.
Time Frame
6 months post-activation
Secondary Outcome Measure Information:
Title
Comparison of Epworth Sleepiness Scale (ESS), between the two randomization arms
Description
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.
Time Frame
6 months post-activation
Title
Comparison of Oxygen Desaturation Index (ODI), between the two randomization arms
Description
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.
Time Frame
6 months post-activation
Title
Comparison of Therapy Usage (hours per week), between the two randomization arms
Description
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.
Time Frame
6 months post-activation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Indiana University School of Medicine
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Massachusetts Eye and Ear Infirmary
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44104
Country
United States
Facility Name
Ohio Sleep Medicine Institute
City
Dublin
State/Province
Ohio
ZIP/Postal Code
43107
Country
United States
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
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)
We'll reach out to this number within 24 hrs