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NCT03025464 · ClinicalTrials.gov registry record · Phase 2
Validation of Sleep Apnea Screening Device Phase II
A Phase 2 study, sponsored by University of Michigan.
- Terminated
- Registry status
- Phase 2
- Development phase
- 30
- Enrollment target
NCT03025464: Clinical Trial Phase 2 study, sponsored by University of Michigan.
NCT03025464 is a Phase 2 study that was terminated before completion, run by University of Michigan. The registered enrollment target is 30 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03025464, a Phase 2 study, was terminated before completion, sponsored by University of Michigan.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 30 participants
- Enrollment target
Study Summary
Obstructive sleep apnea (OSA) is the most common type of sleep apnea. The marketplace currently does not have an affordable, easy-to-use, over-the-counter, home-based OSA screening device. An affordable, available, FDA-approved and easy-to-use over-the-counter OSA screening tool would allow greater screening of at-risk individuals, especially in underserved communities with low socioeconomic status, hopefully encouraging a greater proportion of such individuals to seek treatment for their condition. Over the past year, this investigative team has engineered a small screening device (Zerify®) for OSA and obtained preliminary evidence of its efficacy in a clinical population under a NIMHD-sponsored Phase I STTR award. Phase I Specific Aims 1 and 2 focused on developing a small (1.5 x 2.5 x 0.2 inches) semiconductor sensor that could store sound/motion data, transfer these data to a computer, and detect non-clinical simulated apnea events with a specificity and specificity exceeding 90%. Phase I Specific Aim 3 established the preliminary psychometric performance data of the screening device in a clinical sample of 52 patients (13% African American, 6% Asian, 4% Mixed or Other Race) against gold-standard polysomnography. Phase II proposal aims to optimize the engineered hardware and associated OSA algorithms, create a patient companion app and wireless healthcare provider dashboard, and compare the efficacy of this screening device to the most commonly utilized sleep apnea screener, the home sleep apnea test (HSAT).
Primary Outcome
Specificity of Zansors' device to detect hypopneas and apneas compared to home sleep apnea test devices and to polysomnography over an 8-hour period of sleep at 30-second intervals.
Interventions
- DEVICE Obstructive Sleep Apnea Screening Device
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2017-11-14 |
| Est. Completion | 2019-03-31 |
| Phase | Phase 2 |
Why NCT03025464 stopped before completion
NCT03025464 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (77% lower).
The record links to 0 conditions, and to 1 intervention - of which Obstructive Sleep Apnea Screening Device is the first listed.
NCT03025464 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03025464 about?
NCT03025464 is a clinical study titled "Validation of Sleep Apnea Screening Device Phase II". Obstructive sleep apnea (OSA) is the most common type of sleep apnea. The marketplace currently does not have an affordable, easy-to-use, over-the-counter, home-based OSA screening device. An affordable, available, FDA-approved and easy-to-use over-the-counter OSA screening tool would allow greater ...
What is the current status of trial NCT03025464?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 30 participants. The study started on 2017-11-14. Estimated completion is 2019-03-31.
What interventions are being tested in trial NCT03025464?
The interventions under investigation include: Obstructive Sleep Apnea Screening Device (DEVICE).
Who is sponsoring clinical trial NCT03025464?
This trial is sponsored by University of Michigan, which has 1,327 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03025464's enrollment target sits among peer trials
30 1582nd of 2000 higher than 332 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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