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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 is a Phase 2 study that was terminated before completion, run by University of Michigan. The registered enrollment target is 30 participants.
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).
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03025464
The ClinicalTrials.gov registry entry for NCT03025464 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Michigan, which has 1,327 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Obstructive Sleep Apnea Screening Device is the first listed.
NCT03025464 reports 0 study locations.
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.
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