A Study to Evaluate an Under-mattress Sleep Monitor Vs. a Home Sleep Apnea Test to Diagnose Obstructive Sleep Apnea

Overview

About this study

The purpose of this study is to eEvaluate an under-mattress sleep monitor compared to a peripheral arterial tonometry home sleep apnea test device in the diagnosis of obstructive sleep apnea.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

Age ≥ 22 years old.
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:

≤ 22 years old.
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.
*https://goldcopd.org/wp-content/uploads/2018/02/WMS-GOLD-2018-Feb-Final-to-print-v2.pdf.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location	Status
Rochester, Minn. Mayo Clinic principal investigator Timothy Morgenthaler, M.D.	Closed for enrollment

Mayo Clinic Location

Status

Rochester, Minn.

Mayo Clinic principal investigator

Timothy Morgenthaler, M.D.

Closed for enrollment

More information

Publications

In patients with atrial fibrillation (AF), the prevalence of moderate-to-severe sleep-disordered breathing (SDB) ranges between 21% and 72% and observational studies have demonstrated that SDB reduces the efficacy of rhythm control strategies, while treatment with continuous positive airway pressure lowers the rate of AF recurrence. Currently, the number of apneas and hypopneas per hour (apnea-hypopnea-index, AHI) determined during a single overnight sleep study is clinically used to assess the severity of SDB. However, recent studies suggest that SDB-severity in an individual patient is not stable over time but exhibits a considerable night-to-night variability which cannot be detected by only one overnight sleep assessment. Nightly SDB-severity assessment rather than the single-night diagnosis by one overnight sleep study may better reflect the exposure to SDB-related factors and yield a superior metric to determine SDB-severity in the management of AF. In this review we discuss mechanisms of night-to-night SDB variability, arrhythmogenic consequences of night-to-night SDB variability, strategies for longitudinal assessment of nightly SDB-severity and clinical implications for screening and management of SDB in AF patients. Read More on PubMed
Poor sleep is increasingly being recognized as an important prognostic parameter of health. For those with suspected sleep disorders, patients are referred to sleep clinics, which guide treatment. However, sleep clinics are not always a viable option due to their high cost, a lack of experienced practitioners, lengthy waiting lists, and an unrepresentative sleeping environment. A home-based noncontact sleep/wake monitoring system may be used as a guide for treatment potentially stratifying patients by clinical need or highlighting longitudinal changes in sleep and nocturnal patterns. This paper presents the evaluation of an undermattress sleep monitoring system for noncontact sleep/wake discrimination. A large dataset of sensor data with concomitant sleep/wake state was collected from both younger and older adults participating in a circadian sleep study. A thorough training/testing/validation procedure was configured and optimized feature extraction and sleep/wake discrimination algorithms evaluated both within and across the two cohorts. An accuracy, sensitivity, and specificity of 74.3%, 95.5%, and 53.2% is reported over all subjects using an external validation dataset (71.9%, 87.9%, and 56% and 77.5%, 98%, and 57% is reported for younger and older subjects, respectively). These results compare favorably with similar research, however this system provides an ambient alternative suitable for long-term continuous sleep monitoring, particularly among vulnerable populations. Read More on PubMed

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