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

• ClinicalTrials.gov Identifier: NCT04778748
• Recruitment Status: Completed
• First Posted: March 3, 2021
• Last Update Posted: May 5, 2022
• Sponsor: Mayo Clinic
• Collaborator: Withings
• Information provided by (Responsible Party): Timothy Morgenthaler, Mayo Clinic

Study Description

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.

Study Design

• Study Type: Observational
• Actual 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
• Actual Primary Completion Date: December 20, 2021
• Actual Study Completion Date: December 20, 2021

Groups and Cohorts

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.

Outcome Measures

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

Eligibility Criteria

• 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

Contacts and Locations

Locations

United States, Minnesota

Mayo Clinic in Rochester

Rochester, Minnesota, United States, 55905

Sponsors and Collaborators

Mayo Clinic

Withings

Investigators

• Principal Investigator: Timothy Morgenthaler, MD; Mayo Clinic

More Information

Additional Information:

Patent 

Patent 

Mayo Clinic Clinical Trials 

Publications:

Linz D, Baumert M, Desteghe L, Kadhim K, Vernooy K, Kalman JM, Dobrev D, Arzt M, Sastry M, Crijns HJGM, Schotten U, Cowie MR, McEvoy RD, Heidbuchel H, Hendriks J, Sanders P, Lau DH. Nightly sleep apnea severity in patients with atrial fibrillation: Potential applications of long-term sleep apnea monitoring. Int J Cardiol Heart Vasc. 2019 Oct 18;24:100424. doi: 10.1016/j.ijcha.2019.100424. eCollection 2019 Sep.

Sadek I, Biswas J, Abdulrazak B. Ballistocardiogram signal processing: a review. Health Inf Sci Syst. 2019 May 16;7(1):10. doi: 10.1007/s13755-019-0071-7. eCollection 2019 Dec.

Walsh L, McLoone S, Ronda J, Duffy JF, Czeisler CA. Noncontact Pressure-Based Sleep/Wake Discrimination. IEEE Trans Biomed Eng. 2017 Aug;64(8):1750-1760. doi: 10.1109/TBME.2016.2621066. Epub 2016 Oct 25.

• Responsible Party: Timothy Morgenthaler, Principal Investigator, Mayo Clinic
• ClinicalTrials.gov Identifier: NCT04778748
• Other Study ID Numbers: 20-010024
• First Posted: March 3, 2021
• Last Update Posted: May 5, 2022
• Last Verified: April 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

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