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

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

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.

Study Overview

• Status: Completed
• Conditions: Sleep Apnea, Obstructive
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 60

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic in Rochester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Diagnosis of OSA

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The apnea hypopnea index (AHI)	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.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensitivity	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.	12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Positive likelihood ratio	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	12 months

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Collaborators: Withings
• Investigators: Principal Investigator: Timothy Morgenthaler, MD, Mayo Clinic

Publications and helpful links

General 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.

Helpful Links

• Mayo Clinic Clinical Trials
• Patent
• Patent

Study record dates

Study Major Dates

• Study Start (Actual): April 22, 2021
• Primary Completion (Actual): December 20, 2021
• Study Completion (Actual): December 20, 2021

Study Registration Dates

• First Submitted: January 29, 2021
• First Submitted That Met QC Criteria: February 28, 2021
• First Posted (Actual): March 3, 2021

Study Record Updates

• Last Update Posted (Actual): May 5, 2022
• Last Update Submitted That Met QC Criteria: April 29, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Apnea
• Other Study ID Numbers: 20-010024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No