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| Name | Class |
|---|---|
| Withings | INDUSTRY |
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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.
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 WatchPATâ„¢ 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Under-mattress sleep monitor | Diagnostic Test | Under-mattress sleep monitor for patients with a confirmed diagnosis of Obstructive Sleep Apnea. |
|
| 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 |
| 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 |
| 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 |
Inclusion Criteria:
Clinician suspects of having OSA due to presence of any:
Exclusion Criteria:
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Diagnosis of OSA
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| Name | Affiliation | Role |
|---|---|---|
| Timothy Morgenthaler, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31763438 | Background | 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. | |
| 31114676 |
| Label | URL |
|---|---|
| Patent | View source |
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| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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| 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. |
| 27845651 | 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. |
| 36441446 | Derived | 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. |
| Mayo Clinic Clinical Trials | View source |
| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |