Trial Outcomes & Findings for Clinical Validation of New Commercial Sleep Monitoring Devices (NCT NCT02779543)
NCT ID: NCT02779543
Last Updated: 2019-03-14
Results Overview
Statistical analysis will examine agreement levels of sleep metrics such as Total Sleep Time (TST).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
200 participants
Primary outcome timeframe
1 night, approximately 9 hours.
Results posted on
2019-03-14
Participant Flow
Participant milestones
| Measure |
Fitbit Charge 2
Willing subjects, after providing informed consent, will be fitted with Fitbit Charge 2 on the wrist of their non dominant hand when prepared for the sleep study by a technician. Sleep monitoring device(s) will be removed from the subject's wrist in the morning at the conclusion of the sleep study.
Fitbit: Subjects will be recruited from those patients attending a regularly scheduled overnight PSG sleep study at the Weill Cornell Medical College Center for Sleep Medicine.
|
Microsoft Band 2
Willing subjects, after providing informed consent, will be fitted with Microsoft Band 2 on the wrist of their non dominant hand when prepared for the sleep study by a technician. Sleep monitoring device(s) will be removed from the subject's wrist in the morning at the conclusion of the sleep study.
Microsoft Band 2: Subjects will be recruited from those patients attending a regularly scheduled overnight PSG sleep study at the Weill Cornell Medical College Center for Sleep Medicine.
|
|---|---|---|
|
Overall Study
STARTED
|
100
|
100
|
|
Overall Study
COMPLETED
|
100
|
100
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Clinical Validation of New Commercial Sleep Monitoring Devices
Baseline characteristics by cohort
| Measure |
Fitbit Charge 2
n=100 Participants
Willing subjects, after providing informed consent, will be fitted with Fitbit Charge 2 on the wrist of their non dominant hand when prepared for the sleep study by a technician. Sleep monitoring device(s) will be removed from the subject's wrist in the morning at the conclusion of the sleep study.
Fitbit: Subjects will be recruited from those patients attending a regularly scheduled overnight PSG sleep study at the Weill Cornell Medical College Center for Sleep Medicine.
|
Microsoft Band 2
n=100 Participants
Willing subjects, after providing informed consent, will be fitted with Microsoft Band 2 on the wrist of their non dominant hand when prepared for the sleep study by a technician. Sleep monitoring device(s) will be removed from the subject's wrist in the morning at the conclusion of the sleep study.
Microsoft Band 2: Subjects will be recruited from those patients attending a regularly scheduled overnight PSG sleep study at the Weill Cornell Medical College Center for Sleep Medicine.
|
Total
n=200 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
63 Participants
n=5 Participants
|
75 Participants
n=7 Participants
|
138 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
37 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
42 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
81 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
58 Participants
n=5 Participants
|
61 Participants
n=7 Participants
|
119 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
100 Participants
n=5 Participants
|
100 Participants
n=7 Participants
|
200 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
100 participants
n=5 Participants
|
100 participants
n=7 Participants
|
200 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 night, approximately 9 hours.Statistical analysis will examine agreement levels of sleep metrics such as Total Sleep Time (TST).
Outcome measures
| Measure |
Microsoft Band 2
n=100 Participants
Willing subjects, after providing informed consent, will be fitted with Microsoft Band 2 on the wrist of their non dominant hand when prepared for the sleep study by a technician. Sleep monitoring device(s) will be removed from the subject's wrist in the morning at the conclusion of the sleep study.
Fitbit: Subjects will be recruited from those patients attending a regularly scheduled overnight PSG sleep study at the Weill Cornell Medical College Center for Sleep Medicine.
|
Fitbit Charge 2
n=100 Participants
Willing subjects, after providing informed consent, will be fitted with Fitbit Charge 2 on the wrist of their non dominant hand when prepared for the sleep study by a technician. Sleep monitoring device(s) will be removed from the subject's wrist in the morning at the conclusion of the sleep study.
Fitbit: Subjects will be recruited from those patients attending a regularly scheduled overnight PSG sleep study at the Weill Cornell Medical College Center for Sleep Medicine.
|
|---|---|---|
|
Total Sleep Time as Measured by Fitbit Charge2 or Microsoft Band2.
|
394.9 minutes
Standard Deviation 105.8
|
437.0 minutes
Standard Deviation 80.6
|
SECONDARY outcome
Timeframe: 1 night, approximately 9 hours.Statistical analysis will examine agreement levels of sleep metrics such as Sleep Onset Latency (SOL).
Outcome measures
| Measure |
Microsoft Band 2
n=100 Participants
Willing subjects, after providing informed consent, will be fitted with Microsoft Band 2 on the wrist of their non dominant hand when prepared for the sleep study by a technician. Sleep monitoring device(s) will be removed from the subject's wrist in the morning at the conclusion of the sleep study.
Fitbit: Subjects will be recruited from those patients attending a regularly scheduled overnight PSG sleep study at the Weill Cornell Medical College Center for Sleep Medicine.
|
Fitbit Charge 2
n=100 Participants
Willing subjects, after providing informed consent, will be fitted with Fitbit Charge 2 on the wrist of their non dominant hand when prepared for the sleep study by a technician. Sleep monitoring device(s) will be removed from the subject's wrist in the morning at the conclusion of the sleep study.
Fitbit: Subjects will be recruited from those patients attending a regularly scheduled overnight PSG sleep study at the Weill Cornell Medical College Center for Sleep Medicine.
|
|---|---|---|
|
Sleep Onset Latency as Measured by Fitbit Charge2 or Microsoft Band2.
|
26.2 minutes
Standard Deviation 30.5
|
8.8 minutes
Standard Deviation 13.7
|
SECONDARY outcome
Timeframe: 1 night, approximately 9 hours.Statistical analysis will examine agreement levels of sleep metrics such as Wake After Sleep Onset (WASO)
Outcome measures
| Measure |
Microsoft Band 2
n=100 Participants
Willing subjects, after providing informed consent, will be fitted with Microsoft Band 2 on the wrist of their non dominant hand when prepared for the sleep study by a technician. Sleep monitoring device(s) will be removed from the subject's wrist in the morning at the conclusion of the sleep study.
Fitbit: Subjects will be recruited from those patients attending a regularly scheduled overnight PSG sleep study at the Weill Cornell Medical College Center for Sleep Medicine.
|
Fitbit Charge 2
n=100 Participants
Willing subjects, after providing informed consent, will be fitted with Fitbit Charge 2 on the wrist of their non dominant hand when prepared for the sleep study by a technician. Sleep monitoring device(s) will be removed from the subject's wrist in the morning at the conclusion of the sleep study.
Fitbit: Subjects will be recruited from those patients attending a regularly scheduled overnight PSG sleep study at the Weill Cornell Medical College Center for Sleep Medicine.
|
|---|---|---|
|
Wake Time After Sleep Onset as Measured by Fitbit Charge2 or Microsoft Band2.
|
88.0 minutes
Standard Deviation 71.7
|
30.3 minutes
Standard Deviation 42.0
|
SECONDARY outcome
Timeframe: 1 night, approximately 9 hours.Statistical analysis will examine agreement levels of sleep metrics such as Sleep Efficiency (SE)
Outcome measures
| Measure |
Microsoft Band 2
n=100 Participants
Willing subjects, after providing informed consent, will be fitted with Microsoft Band 2 on the wrist of their non dominant hand when prepared for the sleep study by a technician. Sleep monitoring device(s) will be removed from the subject's wrist in the morning at the conclusion of the sleep study.
Fitbit: Subjects will be recruited from those patients attending a regularly scheduled overnight PSG sleep study at the Weill Cornell Medical College Center for Sleep Medicine.
|
Fitbit Charge 2
n=100 Participants
Willing subjects, after providing informed consent, will be fitted with Fitbit Charge 2 on the wrist of their non dominant hand when prepared for the sleep study by a technician. Sleep monitoring device(s) will be removed from the subject's wrist in the morning at the conclusion of the sleep study.
Fitbit: Subjects will be recruited from those patients attending a regularly scheduled overnight PSG sleep study at the Weill Cornell Medical College Center for Sleep Medicine.
|
|---|---|---|
|
Sleep Efficiency as Measured by Fitbit Charge2 or Microsoft Band2.
|
82.1 percentage of sleep efficiency
Standard Deviation 15.5
|
93.4 percentage of sleep efficiency
Standard Deviation 9.6
|
Adverse Events
Fitbit Charge 2
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Microsoft Band 2
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place