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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Sleep Apnea, Obstructive

Intervention / Treatment
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* Diagnostic Test: Under-mattress sleep monitor


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 22 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Obstructive Sleep Apnea<br>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<br>* Under-mattress sleep monitor for patients with a confirmed diagnosis of Obstructive Sleep Apnea.<br>|

What is the study measuring?
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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 |