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| Name | Class |
|---|---|
| The Reading Hospital and Medical Center | OTHER |
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The purpose of this research study is to collect health and physiological data using commercially available wristband fitness tracker devices (FitBit and Garmin devices) to help determine their accuracy and reliability at measuring percent of night spent in REM sleep, oxygen desaturation, and apnea hypopnea index compared with currently available methods of in-laboratory polysomnogram and home sleep testing.
To date, there is an incomplete picture of the reliability of wearable device trackers to depict sleep quantity and sleep staging information. Prior studies have compared various iterations of wearable sleep trackers to the so-called gold standard of PSG, often but not universally in health populations. A number of important observations have been made to date.
For the current study, the investigators do not plan to examine an epoch by epoch assessment of sleep staging as a primary analysis, in part due to its inherent limitations consisting of: (a) lack of raw data from device; (b) difficulty matching up epochs due to differences in timing of the so-called "window" of time observed (30 seconds versus one minute); (c) differences in sleep time recording, thus resulting in different denominators of sleep time; (d) poor test-retest or interrater variability for PSG scoring itself, even among expert academic centers performing epoch by epoch analyses of the very same PSG. Instead, the investigators plan to focus on a more clinically accessible and, for the consumer, more relevant question: how well does the amount (or the percentage) of REM sleep and total sleep time estimated by the wearable sleep tracker correlate with a simultaneous sleep study? Secondary analyses will also assess sleep/wake and additional sleep stage comparisons, and assessments of respiratory parameters of oxygen desaturation, and a comparison of wrist tracker device and PSG sleep compared to Level 3 home sleep test derived recording time, in a population of subjects being evaluated for sleep apnea and other sleep disorders. Summary assessments of the sleep variables for the night will be compared to assess the accuracy of the wearable devices and Level 3 home sleep test to polysomnogram. Through the study, the investigators hope to contribute to building a body of evidence assessing the level of accuracy of the latest generation of consumer wearable sleep tracking devices. The investigators plan to use two devices, the FBI3 and the GVS5 fitness activity trackers, for the study, as these devices are among the most recent versions available, are widely used, are highly affordable (models under $150), and provide ease of measurement (as no continuous Bluetooth smartphone connection is needed to collect data).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients referred to Sleep Health Center for diagnostic PSG | Prospective obstructive sleep apnea patients referred for diagnostic overnight polysomnogram test |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sleep Tracking Devices | Device | Observational Study, Smartwatches and home sleep device for sleep and respiratory monitoring |
|
| Measure | Description | Time Frame |
|---|---|---|
| Monitoring of Sleep Staging | Percent of the night spent in REM sleep recorded in each device | Throughout study completion, approximately 5 months |
| Measure | Description | Time Frame |
|---|---|---|
| Oxygen Desaturation | Oximetry data derived from devices | Throughout study completion, approximately 5 months |
| Measure | Description | Time Frame |
|---|---|---|
| Apnea Hypopnea Index | Apnea Hypopnea Index (AHI) calculated from measured recording time in Level 3 home sleep test. Having more than 5 events is considered abnormal and having 30 or more events is considered severe. | Throughout study completion, approximately 5 months |
Inclusion criteria:
Exclusion criteria
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Patients recently ordered for diagnostic polysomnogram.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alec Platt, MD | Contact | 6106855864 | 238 | aplatt@lungmd.net |
| Eric Abreu, MPH | Contact | 6106855864 | 167 | eabreu@lungmd.net |
| Name | Affiliation | Role |
|---|---|---|
| Alec Platt, MD | Respiratory Specialists | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Respiratory Specialists | Wyomissing | Pennsylvania | 19610 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30789439 | Background | de Zambotti M, Cellini N, Goldstone A, Colrain IM, Baker FC. Wearable Sleep Technology in Clinical and Research Settings. Med Sci Sports Exerc. 2019 Jul;51(7):1538-1557. doi: 10.1249/MSS.0000000000001947. | |
| 33782687 | Background | Grandner MA, Lujan MR, Ghani SB. Sleep-tracking technology in scientific research: looking to the future. Sleep. 2021 May 14;44(5):zsab071. doi: 10.1093/sleep/zsab071. No abstract available. |
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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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|
| 31538605 | Background | Lee XK, Chee NIYN, Ong JL, Teo TB, van Rijn E, Lo JC, Chee MWL. Validation of a Consumer Sleep Wearable Device With Actigraphy and Polysomnography in Adolescents Across Sleep Opportunity Manipulations. J Clin Sleep Med. 2019 Sep 15;15(9):1337-1346. doi: 10.5664/jcsm.7932. |
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| 19480230 | Background | Santos-Silva R, Sartori DE, Truksinas V, Truksinas E, Alonso FF, Tufik S, Bittencourt LR. Validation of a portable monitoring system for the diagnosis of obstructive sleep apnea syndrome. Sleep. 2009 May;32(5):629-36. doi: 10.1093/sleep/32.5.629. |
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| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |