Obstructive Sleep ApneaHOMENCT04416542
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)
A study testing Home Sleep Testing in people with Obstructive Sleep Apnea, run by Inspire Medical Systems, Inc. at 5 sites in United States.
Trial summary
Inspire intends to conduct this study to compare Apnea-Hypopnea Index (AHI), between the two randomization arms, at 6 months post-activation Read more about this study
- Who is it for?
- Ages 22 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- Home Sleep Testing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 5 sitesUnited States
- Study dates
- 28 Jul 2020to 10 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Massachusetts Eye and Ear Infirmary
Boston, Massachusetts, 02115
Cleveland Clinic Foundation
Cleveland, Ohio, 44104
Ohio Sleep Medicine Institute
Dublin, Ohio, 43107
Indiana University School of Medicine
Indianapolis, Indiana, 46202
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
About this study
Inspire intends to conduct this study to compare Apnea-Hypopnea Index (AHI), between the two randomization arms, at 6 months post-activation
Read the 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
- Being tested
- Home Sleep Testing
- Keywords
- OSA
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home Sleep TestingDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Diagnostic Test: Home Sleep Testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months post-activation
Secondary outcomes (3)
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.
Measured: 6 months post-activation
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.
Measured: 6 months post-activation
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.
Measured: 6 months post-activation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2020
- Study start28 Jul 2020
- Primary completion10 Jun 2022
- Study completion10 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inspire Medical Systems, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04416542
- Sponsor's protocol ID
- 2020-001
- Acronym
- HOME
- Status last verified
- Sep 2020
- First submitted
- 1 Jun 2020
- Last updated
- 21 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 37421320
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT04416542
- Acronym / sponsor ID
- HOME / 2020-001
- Conditions
- Obstructive Sleep Apnea
- Keywords
- OSA
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Inspire Medical Systems, Inc.Industry (pharma, biotech, devices)
- Study start
- 28 Jul 2020 (actual)
- Primary completion
- 10 Jun 2022 (actual)
- Study completion
- 10 Jun 2022 (actual)
- First posted
- 4 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Diagnostic Test: Home Sleep TestingSubjects 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 |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Home Sleep TestingTwo-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. | Diagnostic test | Home Monitoring |
Primary outcome
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.
3 secondary outcomes
Comparison of Epworth Sleepiness Scale (ESS), between the two randomization arms
Time frame: 6 months post-activation
Comparison of Oxygen Desaturation Index (ODI), between the two randomization arms
Time frame: 6 months post-activation
Comparison of Therapy Usage (hours per week), between the two randomization arms
Time frame: 6 months post-activation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2022.
- Derived from this study: PubMed 37421320Kent 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home Sleep Testing in people with Obstructive Sleep Apnea, run by Inspire Medical Systems, Inc. at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of Apnea-Hypopnea Index (AHI), between the two randomization arms (time frame: 6 months post-activation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04416542, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2022.