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

NCT04778748 | Completed

• 1 other identifier: 20-010024
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep Apnea, Obstructive

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Sensitivity

  12 months

Other Outcomes (1)

• Positive likelihood ratio

  12 months

Study Arms (1)

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

Interventions

Under-mattress sleep monitor DIAGNOSTIC_TEST

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

Obstructive Sleep Apnea

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Diagnosis of OSA

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead
• Withings: collaborator

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Publications (4)

• 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.

  PMID: 31763438 BACKGROUND

• 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.

  PMID: 31114676 BACKGROUND

• 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.

  PMID: 27845651 BACKGROUND

• Jagielski JT, Bibi N, Gay PC, Junna MR, Carvalho DZ, Williams JA, Morgenthaler TI. Evaluating an under-mattress sleep monitor compared to a peripheral arterial tonometry home sleep apnea test device in the diagnosis of obstructive sleep apnea. Sleep Breath. 2023 Aug;27(4):1433-1441. doi: 10.1007/s11325-022-02751-7. Epub 2022 Nov 28.

  PMID: 36441446 DERIVED

Related Links

• Patent
• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Timothy Morgenthaler, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 29, 2021
• First Posted: March 3, 2021
• Study Start: April 22, 2021
• Primary Completion: December 20, 2021
• Study Completion: December 20, 2021
• Last Updated: May 5, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)