N/A
Completed N=200
Clinical Validation of New Commercial Sleep Monitoring Devices
Source: ClinicalTrials.gov NCT02779543 ↗Enrolled (actual)
200
Serious AEs
0.0%
Results posted
Mar 2019
Primary outcomePrimary: Total Sleep Time as Measured by Fitbit Charge2 or Microsoft Band2. — 437.0; 394.9 minutes — p=<0.001
Summary
This study seeks to validate three new commercial sleep monitoring devices: Fitbit, Jawbone UP, and Microsoft Band by comparison against concurrent polysomnography (PSG), which is considered the gold standard for sleep assessment. This research is being done because if proven to accurately analyze sleep,these devices may make conducting in-home sleep studies easier and more affordable in the future.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total Sleep Time as Measured by Fitbit Charge2 or Microsoft Band2. |
437.0; 394.9 | <0.001 sig |
| SECONDARY Sleep Onset Latency as Measured by Fitbit Charge2 or Microsoft Band2. |
8.8; 26.2 | <0.001 sig |
| SECONDARY Wake Time After Sleep Onset as Measured by Fitbit Charge2 or Microsoft Band2. |
30.3; 88.0 | <0.001 sig |
| SECONDARY Sleep Efficiency as Measured by Fitbit Charge2 or Microsoft Band2. |
93.4; 82.1 | <0.001 sig |
Eligibility Criteria
Inclusion Criteria
- Attending a regularly scheduled overnight polysomnography (PSG) sleep study at the Weill Cornell Medical College Center for Sleep Medicine.
Exclusion Criteria
- Not attending a regularly scheduled overnight polysomnography (PSG) sleep study at the Weill Cornell Medical College Center for Sleep Medicine.
- Under 18 or over 80 years old.
- Pregnancy
- Unable to provide informed consent.
Data sourced from ClinicalTrials.gov (NCT02779543). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.