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NCT04778748 · ClinicalTrials.gov registry record
Evaluating an Under-mattress Sleep Monitor Compared to a Peripheral Arterial Tonometry Device in the Diagnosis of Obstructive Sleep Apnea
A clinical trial of Sleep Apnea, Obstructive, sponsored by Mayo Clinic.
- Completed
- Registry status
- 60
- Enrollment target
- 1
- Study location
NCT04778748: Completed study of Sleep Apnea, Obstructive, sponsored by Mayo Clinic.
NCT04778748 is a study of Sleep Apnea, Obstructive that has completed, run by Mayo Clinic. The registered enrollment target is 60 participants, below the 261-participant average among 45 other Sleep Apnea, Obstructive trials with a reported enrollment target (77% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04778748, a study of Sleep Apnea, Obstructive, has completed, sponsored by Mayo Clinic.
- COMPLETED
- Registry status
- 60 participants
- Enrollment target
- 1
- Study location
Study Summary
A device has been developed which is placed under the mattress, thereby escaping contact with patient, which enables monitoring of sleep activity and has been shown in some studies to provide an estimate of the frequency of sleep disordered breathing. If the estimates of sleep disordered breathing from this new device are medically equivalent to current excepted home sleep apnea test devices within clinically important ranges of sleep disordered breathing, it may have several benefits. This study is designed to help answer several important clinical questions, namely, is the new device clinically equivalent to an established HSAT device for patients who have at least moderately severe OSA, and what is the effect of multiple nights on classification of severity and presence of OSA.
Primary Outcome
The apnea hypopnea index (AHI) provided by one-night of testing with the WatchPAT™ is equivalent to the AHI provided by the mean of 7 nights use of the Withings™ sleep monitor. The equivalence margin will be an AHI≤5/hr.
Conditions Studied
Interventions
- DIAGNOSTIC_TEST Under-mattress sleep monitor
Study Locations (1)
Minnesota
- Mayo Clinic in Rochester - Rochester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2021-04-22 |
| Est. Completion | 2021-12-20 |
What the finished NCT04778748 record still lists
NCT04778748 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 261-participant average among 45 other Sleep Apnea, Obstructive trials with a reported enrollment target (77% lower).
The record links to 1 condition, with Sleep Apnea, Obstructive appearing as the primary indexed condition, and to 1 intervention - of which Under-mattress sleep monitor is the first listed.
NCT04778748 reports a single indexed study location in Minnesota.
Frequently Asked Questions
What is clinical trial NCT04778748 about?
NCT04778748 is a clinical study titled "Evaluating an Under-mattress Sleep Monitor Compared to a Peripheral Arterial Tonometry Device in the Diagnosis of Obstructive Sleep Apnea". A device has been developed which is placed under the mattress, thereby escaping contact with patient, which enables monitoring of sleep activity and has been shown in some studies to provide an estimate of the frequency of sleep disordered breathing. If the estimates of sleep disordered breathing f...
What is the current status of trial NCT04778748?
This trial is currently completed. The enrollment target is 60 participants. The study started on 2021-04-22. Estimated completion is 2021-12-20.
What conditions does trial NCT04778748 study?
This clinical trial studies the following conditions: Sleep Apnea, Obstructive.
What interventions are being tested in trial NCT04778748?
The interventions under investigation include: Under-mattress sleep monitor (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT04778748?
This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04778748 being conducted?
This trial has 1 study location across Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Sleep Apnea, Obstructive
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04778748's enrollment target sits among peer trials
60 23rd of 45 higher than 20 of 45 other Sleep Apnea, Obstructive trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Sleep Apnea, Obstructive 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.
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