Trial Outcomes & Findings for Reliability of Consumer Sleep Trackers in Patients Suffering From Obstructive Sleep Apnea Syndrome (NCT NCT02967367)
NCT ID: NCT02967367
Last Updated: 2020-03-24
Results Overview
time spent in bed during the night (minutes)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
36 participants
Primary outcome timeframe
one night (up to 600 minutes)
Results posted on
2020-03-24
Participant Flow
Participant milestones
| Measure |
Jawbone/Withings Sleep Trackers, Bodymedia Sensewear
2 types of Consumer sleep trackers, including Jawbone and Withings, and one research actigraph (Bodymedia Sensewear) are added to classical polysomnography in order to assess their accuracy to measure sleep parameters in obstructive sleep apnea patients
Jawbone sleep tracker: During one night of polysomnographic recording, investigators are going to place these 3 accelerometers on the wrist of the patient
Withings sleep tracker: During one night of polysomnographic recording, investigators are going to place these 3 accelerometers on the wrist of the patient
BodyMedia Sense Wear accelerometer: During one night of polysomnographic recording, investigators are going to place these 3 accelerometers on the wrist of the patient
|
|---|---|
|
Overall Study
STARTED
|
36
|
|
Overall Study
COMPLETED
|
22
|
|
Overall Study
NOT COMPLETED
|
14
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Jawbone/Withings Sleep Trackers, Bodymedia Sensewear
n=22 Participants
2 types of Consumer sleep trackers, including Jawbone and Withings, and one research actigraph (Bodymedia Sensewear) are added to classical polysomnography in order to assess their accuracy to measure sleep parameters in obstructive sleep apnea patients
Jawbone sleep tracker: During one night of polysomnographic recording, investigators are going to place these 3 accelerometers on the wrist of the patient
Withings sleep tracker: During one night of polysomnographic recording, investigators are going to place these 3 accelerometers on the wrist of the patient
BodyMedia Sense Wear accelerometer: During one night of polysomnographic recording, investigators are going to place these 3 accelerometers on the wrist of the patient
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=22 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
18 Participants
n=22 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=22 Participants
|
|
Age, Continuous
|
53 years
STANDARD_DEVIATION 13 • n=22 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=22 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=22 Participants
|
PRIMARY outcome
Timeframe: one night (up to 600 minutes)time spent in bed during the night (minutes)
Outcome measures
| Measure |
Jawbone/Withings Sleep Trackers, Bodymedia Sensewear
n=22 Participants
2 types of Consumer sleep trackers, including Jawbone and Withings, and one research actigraph (Bodymedia Sensewear) are added to classical polysomnography in order to assess their accuracy to measure sleep parameters in obstructive sleep apnea patients
Jawbone sleep tracker: During one night of polysomnographic recording, investigators are going to place these 3 accelerometers on the wrist of the patient
Withings sleep tracker: During one night of polysomnographic recording, investigators are going to place these 3 accelerometers on the wrist of the patient
BodyMedia Sense Wear accelerometer: During one night of polysomnographic recording, investigators are going to place these 3 accelerometers on the wrist of the patient
|
|---|---|
|
Time in Bed
PSG
|
519 min
Standard Deviation 34
|
|
Time in Bed
Bodymedia Sensewear
|
446 min
Standard Deviation 86
|
|
Time in Bed
Jawbone sleep tracker
|
522 min
Standard Deviation 45
|
|
Time in Bed
Withings sleep tracker
|
524 min
Standard Deviation 122
|
PRIMARY outcome
Timeframe: one night (up to 600 minutes)a percentage corresponding to total sleep time divided by time in bed
Outcome measures
| Measure |
Jawbone/Withings Sleep Trackers, Bodymedia Sensewear
n=22 Participants
2 types of Consumer sleep trackers, including Jawbone and Withings, and one research actigraph (Bodymedia Sensewear) are added to classical polysomnography in order to assess their accuracy to measure sleep parameters in obstructive sleep apnea patients
Jawbone sleep tracker: During one night of polysomnographic recording, investigators are going to place these 3 accelerometers on the wrist of the patient
Withings sleep tracker: During one night of polysomnographic recording, investigators are going to place these 3 accelerometers on the wrist of the patient
BodyMedia Sense Wear accelerometer: During one night of polysomnographic recording, investigators are going to place these 3 accelerometers on the wrist of the patient
|
|---|---|
|
Sleep Efficiency
PSG
|
67 percentage of time in bed
Standard Deviation 18
|
|
Sleep Efficiency
Bodymedia Sensewear
|
80 percentage of time in bed
Standard Deviation 14
|
|
Sleep Efficiency
Jawbone sleep tracker
|
78 percentage of time in bed
Standard Deviation 13
|
|
Sleep Efficiency
Withings sleep tracker
|
84 percentage of time in bed
Standard Deviation 11
|
PRIMARY outcome
Timeframe: one night (up to 600 minutes)time spent sleeping during the night (minutes)
Outcome measures
| Measure |
Jawbone/Withings Sleep Trackers, Bodymedia Sensewear
n=22 Participants
2 types of Consumer sleep trackers, including Jawbone and Withings, and one research actigraph (Bodymedia Sensewear) are added to classical polysomnography in order to assess their accuracy to measure sleep parameters in obstructive sleep apnea patients
Jawbone sleep tracker: During one night of polysomnographic recording, investigators are going to place these 3 accelerometers on the wrist of the patient
Withings sleep tracker: During one night of polysomnographic recording, investigators are going to place these 3 accelerometers on the wrist of the patient
BodyMedia Sense Wear accelerometer: During one night of polysomnographic recording, investigators are going to place these 3 accelerometers on the wrist of the patient
|
|---|---|
|
Total Sleep Time
PSG
|
344 min
Standard Deviation 92
|
|
Total Sleep Time
Bodymedia Sensewear
|
358 min
Standard Deviation 90
|
|
Total Sleep Time
Jawbone sleep tracker
|
407 min
Standard Deviation 60
|
|
Total Sleep Time
Withings sleep tracker
|
431 min
Standard Deviation 68
|
SECONDARY outcome
Timeframe: one night (up to 600 minutes)a percentage corresponding to sleep time spent in deep sleep (stage N3 on polysomnography) divided by total sleep time
Outcome measures
| Measure |
Jawbone/Withings Sleep Trackers, Bodymedia Sensewear
n=22 Participants
2 types of Consumer sleep trackers, including Jawbone and Withings, and one research actigraph (Bodymedia Sensewear) are added to classical polysomnography in order to assess their accuracy to measure sleep parameters in obstructive sleep apnea patients
Jawbone sleep tracker: During one night of polysomnographic recording, investigators are going to place these 3 accelerometers on the wrist of the patient
Withings sleep tracker: During one night of polysomnographic recording, investigators are going to place these 3 accelerometers on the wrist of the patient
BodyMedia Sense Wear accelerometer: During one night of polysomnographic recording, investigators are going to place these 3 accelerometers on the wrist of the patient
|
|---|---|
|
Deep Sleep
PSG
|
83 a percentage of total sleep time
Standard Deviation 51
|
|
Deep Sleep
Jawbone sleep tracker
|
243 a percentage of total sleep time
Standard Deviation 74
|
|
Deep Sleep
Withings sleep tracker
|
192 a percentage of total sleep time
Standard Deviation 84
|
SECONDARY outcome
Timeframe: one night (up to 600 minutes)a percentage corresponding to sleep time spent in light sleep (stage N1 and N2 on polysomnography) divided by total sleep time
Outcome measures
| Measure |
Jawbone/Withings Sleep Trackers, Bodymedia Sensewear
n=22 Participants
2 types of Consumer sleep trackers, including Jawbone and Withings, and one research actigraph (Bodymedia Sensewear) are added to classical polysomnography in order to assess their accuracy to measure sleep parameters in obstructive sleep apnea patients
Jawbone sleep tracker: During one night of polysomnographic recording, investigators are going to place these 3 accelerometers on the wrist of the patient
Withings sleep tracker: During one night of polysomnographic recording, investigators are going to place these 3 accelerometers on the wrist of the patient
BodyMedia Sense Wear accelerometer: During one night of polysomnographic recording, investigators are going to place these 3 accelerometers on the wrist of the patient
|
|---|---|
|
Light Sleep
PSG
|
190 a percentage of total sleep time
Standard Deviation 85
|
|
Light Sleep
Jawbone sleep tracker
|
163 a percentage of total sleep time
Standard Deviation 69
|
|
Light Sleep
Withings sleep tracker
|
239 a percentage of total sleep time
Standard Deviation 54
|
Adverse Events
Jawbone/Withings Sleep Trackers, Bodymedia Sensewear
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