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Evaluating an Under-mattress Sleep Monitor Compared to a Peripheral Arterial Tonometry Device in the Diagnosis of Obstructive Sleep Apnea

NCT04778748 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 60

Last updated 2022-05-05

No results posted yet for this 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.

Conditions

  • Sleep Apnea, Obstructive

Interventions

DIAGNOSTIC_TEST

Under-mattress sleep monitor

Under-mattress sleep monitor for patients with a confirmed diagnosis of Obstructive Sleep Apnea.

Sponsors & Collaborators

  • Withings

    collaborator INDUSTRY

  • Mayo Clinic

    lead OTHER

Principal Investigators

  • Timothy Morgenthaler, MD · Mayo Clinic

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-22
Primary Completion
2021-12-20
Completion
2021-12-20

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04778748 on ClinicalTrials.gov