NCT02779543

Clinical Validation of New Commercial Sleep Monitoring Devices

Completed NA Results posted Last updated 14 March 2019

What this trial tests

NA trial testing Fitbit in Sleep Apnea in 200 participants. Completed in 30 July 2018.

Timeline

1 June 2018

Primary endpoint
30 July 2018

30 July 2018

Quick facts

Lead sponsor	Weill Medical College of Cornell University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	single group
Masking	none
Primary purpose	diagnostic
Enrollment	200
Start date	1 June 2018
Primary completion	30 July 2018
Estimated completion	30 July 2018
Sites	1 location across United States

Drugs / interventions tested

• Fitbit
• Jawbone UP
• Microsoft Band

Conditions studied

• Sleep Apnea — all drugs for Sleep Apnea →

Sponsor

Weill Medical College of Cornell University

Who can join

Adults 18 to 80, any sex, with Sleep Apnea. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Total Sleep Time as Measured by Fitbit Charge2 or Microsoft Band2. Primary · 1 night, approximately 9 hours.

Statistical analysis will examine agreement levels of sleep metrics such as Total Sleep Time (TST).

Group	Value	95% CI
Fitbit Charge 2	437.0	± 80.6
Microsoft Band 2	394.9	± 105.8

Sleep Onset Latency as Measured by Fitbit Charge2 or Microsoft Band2. Secondary · 1 night, approximately 9 hours.

Statistical analysis will examine agreement levels of sleep metrics such as Sleep Onset Latency (SOL).

Group	Value	95% CI
Fitbit Charge 2	8.8	± 13.7
Microsoft Band 2	26.2	± 30.5

Wake Time After Sleep Onset as Measured by Fitbit Charge2 or Microsoft Band2. Secondary · 1 night, approximately 9 hours.

Statistical analysis will examine agreement levels of sleep metrics such as Wake After Sleep Onset (WASO)

Group	Value	95% CI
Fitbit Charge 2	30.3	± 42.0
Microsoft Band 2	88.0	± 71.7

Sleep Efficiency as Measured by Fitbit Charge2 or Microsoft Band2. Secondary · 1 night, approximately 9 hours.

Statistical analysis will examine agreement levels of sleep metrics such as Sleep Efficiency (SE)

Group	Value	95% CI
Fitbit Charge 2	93.4	± 9.6
Microsoft Band 2	82.1	± 15.5

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.