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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

Tracking Information
First Submitted Date January 29, 2021
First Posted Date March 3, 2021
Last Update Posted Date June 8, 2021
Actual Study Start Date April 22, 2021
Estimated Primary Completion Date September 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 28, 2021)
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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: February 28, 2021)
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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures
 (submitted: February 28, 2021)
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
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title Evaluating an Under-mattress Sleep Monitor Compared to a Peripheral Arterial Tonometry Device in the Diagnosis of Obstructive Sleep Apnea
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
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.
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.

Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Diagnosis of OSA
Condition Sleep Apnea, Obstructive
Intervention Diagnostic Test: Under-mattress sleep monitor
Under-mattress sleep monitor for patients with a confirmed diagnosis of Obstructive Sleep Apnea.
Study Groups/Cohorts 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.
Intervention: Diagnostic Test: Under-mattress sleep monitor
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: February 28, 2021)
60
Original Estimated Enrollment Same as current
Estimated Study Completion Date March 1, 2022
Estimated Primary Completion Date September 1, 2021   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 22 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Paul Timm (507) 266-6627 Timm.Paul@mayo.edu
Contact: Luke Teigen (507) 266-6627 Teigen.Luke@mayo.edu
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT04778748
Other Study ID Numbers 20-010024
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Timothy Morgenthaler, Mayo Clinic
Study Sponsor Mayo Clinic
Collaborators Withings
Investigators
Principal Investigator: Timothy Morgenthaler, MD Mayo Clinic
PRS Account Mayo Clinic
Verification Date June 2021