Evaluating an Under-mattress Sleep Monitor Compared to a Peripheral Arterial Tonometry Device in the Diagnosis of Obstructive Sleep Apnea
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|ClinicalTrials.gov Identifier: NCT04778748|
Recruitment Status : Not yet recruiting
First Posted : March 3, 2021
Last Update Posted : March 18, 2021
|Condition or disease||Intervention/treatment|
|Sleep Apnea, Obstructive||Diagnostic Test: Under-mattress sleep monitor|
The design will be a prospective test of two diagnostic testing strategies. The tests will take place in the same patient concurrently, so the patient's results from one test will serve as the comparator with the other test device. No randomization or blinding is needed.
Patients will be recruited from the Mayo Clinic Center for Sleep Medicine (and another sleep center with enriched racial variety). Consecutive patients in whom the clinician has ordered a WatchPAT™ will be potential candidates for an opportunity to participate in the study. Patients will be made aware of the trial by invitation from members of the healthcare team. Interested patients will be evaluated according to the inclusion and exclusion criteria.
|Study Type :||Observational|
|Estimated Enrollment :||60 participants|
|Official Title:||Evaluating an Under-mattress Sleep Monitor Compared to a Peripheral Arterial Tonometry Home Sleep Apnea Test Device in the Diagnosis of Obstructive Sleep Apnea|
|Estimated Study Start Date :||April 1, 2021|
|Estimated Primary Completion Date :||September 1, 2021|
|Estimated Study Completion Date :||March 1, 2022|
Obstructive Sleep Apnea
Participants will be provided with a Withings sleep monitor and instructed to begin using it. Effective data collection via the Withings unit should be confirmed for the 5 nights prior to the test night.
After 5 nights of successful data collection with the Withings device, the WatchPAT device will be worn.
Diagnostic Test: Under-mattress sleep monitor
Under-mattress sleep monitor for patients with a confirmed diagnosis of Obstructive Sleep Apnea.
- The apnea hypopnea index (AHI) [ Time Frame: 12 months ]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.
- Sensitivity [ Time Frame: 12 months ]The Withings sleep monitor will have a sensitivity ≥ 0.825 to identify patients with moderate to severe OSA as assessed by a WatchPAT AHI≥15.
- Positive likelihood ratio [ Time Frame: 12 months ]The Withings sleep monitor will have a likelihood ratio ≥ 5 to identify patients with moderate to severe OSA as assessed by a WatchPAT AHI≥15
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04778748
|Contact: Paul Timm||(507) 266-6627||Timm.Paul@mayo.edu|
|Contact: Luke Teigen||(507) 266-6627||Teigen.Luke@mayo.edu|
|United States, Minnesota|
|Mayo Clinic in Rochester|
|Rochester, Minnesota, United States, 55905|
|Principal Investigator:||Timothy Morgenthaler, MD||Mayo Clinic|