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NCT04416542 · ClinicalTrials.gov registry record · NA
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 NA study, sponsored by Inspire Medical Systems.
- Completed
- Registry status
- NA
- Development phase
- 64
- Enrollment target
NCT04416542: Completed NA study, sponsored by Inspire Medical Systems.
NCT04416542 is a NA study that has completed, run by Inspire Medical Systems. The registered enrollment target is 64 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04416542, a NA study, has completed, sponsored by Inspire Medical Systems.
- COMPLETED
- Registry status
- NA
- Development phase
- 64 participants
- Enrollment target
Study Summary
Inspire intends to conduct this study to compare Apnea-Hypopnea Index (AHI), between the two randomization arms, at 6 months post-activation
Primary Outcome
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.
Interventions
- DIAGNOSTIC_TEST Home Sleep Testing
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 64 participants |
| Start Date | 2020-07-28 |
| Est. Completion | 2022-06-10 |
| Phase | NA |
What the finished NCT04416542 record still lists
NCT04416542 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 64 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 1 intervention - of which Home Sleep Testing is the first listed.
NCT04416542 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04416542 about?
NCT04416542 is a clinical study titled "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
What is the current status of trial NCT04416542?
This trial is currently completed. It is a NA study. The enrollment target is 64 participants. The study started on 2020-07-28. Estimated completion is 2022-06-10.
What interventions are being tested in trial NCT04416542?
The interventions under investigation include: Home Sleep Testing (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT04416542?
This trial is sponsored by Inspire Medical Systems, which has 8 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04416542's enrollment target sits among peer trials
64 1147th of 2000 higher than 844 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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