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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 : Recruiting
First Posted : March 3, 2021
Last Update Posted : June 8, 2021
Sponsor:
Collaborator:
Withings
Information provided by (Responsible Party):
Timothy Morgenthaler, Mayo Clinic

Brief 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.

Condition or disease Intervention/treatment
Sleep Apnea, Obstructive Diagnostic Test: Under-mattress sleep monitor

Detailed Description:

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.

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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Case-Only
Time Perspective: Prospective
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
Actual Study Start Date : April 22, 2021
Estimated Primary Completion Date : September 1, 2021
Estimated Study Completion Date : March 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

Group/Cohort Intervention/treatment
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 at least 7 consecutive nights, and the WatchPAT device will be used during one of those same 7 nights.
Diagnostic Test: Under-mattress sleep monitor
Under-mattress sleep monitor for patients with a confirmed diagnosis of Obstructive Sleep Apnea.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


Other Outcome Measures:
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   22 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Diagnosis of OSA
Criteria

Inclusion Criteria:

Clinician suspects of having OSA due to presence of any:

  • STOP-BANG ≥ 3,
  • overnight oximetry with ODI ≥ 5,
  • STOP-BANG≥ 2 and one or more of: disrupted sleep, cognitive complaints, paroxysmal or prior atrial-fibrillation (now in NSR), stroke, TIA
  • Has a smartphone capable of running both Withings and Itamar's app
  • Stable sleeping quarters and schedule (i.e., no overnight shifts) for at least 7 days
  • Domicile has capable wireless internet service

Exclusion Criteria:

  • Uses short-acting nitrates within 3 hours of the study
  • Has a permanent pacemaker
  • Atrial fibrillation or sustained supraventricular arrhythmias
  • Known congestive heart failure Class ≥ 1, or known LVEF< 45%
  • Sustained hypoxemia or hypoventilation (results of RA daytime ABG show SaO2<90% or PaCO2>45 mmHg, or overnight oximetry shows mean SaO2<90%.)
  • Advanced pulmonary disease (COPD GOLD stage ≥ II , pulmonary fibrosis with GAP ≥ 1 or significant dyspnea on exertion

Information from the National Library of Medicine

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


Contacts
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Contact: Paul Timm (507) 266-6627 Timm.Paul@mayo.edu
Contact: Luke Teigen (507) 266-6627 Teigen.Luke@mayo.edu

Locations
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United States, Minnesota
Mayo Clinic in Rochester Recruiting
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Withings
Investigators
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Principal Investigator: Timothy Morgenthaler, MD Mayo Clinic
Additional Information:
Publications of Results:
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Responsible Party: Timothy Morgenthaler, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT04778748    
Other Study ID Numbers: 20-010024
First Posted: March 3, 2021    Key Record Dates
Last Update Posted: June 8, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases