Trial Outcomes & Findings for Multimodal Sleep Intervention Using Wearable Technology (NCT NCT03658954)
NCT ID: NCT03658954
Last Updated: 2025-05-07
Results Overview
This will be recorded using the Timeline Follow-back Interview, based on the U.S. Standard Drink Conversion Chart. Upon results entry, the outcome was updated to include the following: data are log-transformed total alcohol drinks consumed over time from Week 4 to Week 12 follow-up, controlling for baseline.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
120 participants
Primary outcome timeframe
weeks 4 through 12
Results posted on
2025-05-07
Participant Flow
Participant milestones
| Measure |
Advice
Participants receive only web-based sleep hygiene advice
Advice: Once per week for two weeks, participants will come to in-person visits to receive brief web-based sleep hygiene advice.
|
Advice + Self-monitoring
Participants receive web-based sleep hygiene advice + sleep/alcohol diary self-monitoring
Advice: Once per week for two weeks, participants will come to in-person visits to receive brief web-based sleep hygiene advice.
Self-monitoring: Participants will complete daily web-based sleep and alcohol smartphone diaries for two weeks.
|
Advice + Self-monitoring + Feedback
Participants receive web-based sleep hygiene advice + sleep/alcohol diary self-monitoring + sleep/alcohol data feedback
Advice: Once per week for two weeks, participants will come to in-person visits to receive brief web-based sleep hygiene advice.
Self-monitoring: Participants will complete daily web-based sleep and alcohol smartphone diaries for two weeks.
Feedback: Participants will receive feedback once per week for two weeks on their sleep and alcohol consumption, using all possible data derived from Philips actigraphs and SCRAM blood-alcohol trackers and smartphone diary data.
|
|---|---|---|---|
|
Overall Study
STARTED
|
30
|
30
|
60
|
|
Overall Study
Completed 2 Week Treatment
|
28
|
30
|
60
|
|
Overall Study
Completed 12 Week Follow-up
|
27
|
29
|
59
|
|
Overall Study
COMPLETED
|
28
|
30
|
60
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Multimodal Sleep Intervention Using Wearable Technology
Baseline characteristics by cohort
| Measure |
Advice
n=30 Participants
Participants receive only web-based sleep hygiene advice
Advice: Once per week for two weeks, participants will come to in-person visits to receive brief web-based sleep hygiene advice.
|
Advice + Self-monitoring
n=30 Participants
Participants receive web-based sleep hygiene advice + sleep/alcohol diary self-monitoring
Advice: Once per week for two weeks, participants will come to in-person visits to receive brief web-based sleep hygiene advice.
Self-monitoring: Participants will complete daily web-based sleep and alcohol diaries for two weeks.
|
Advice + Self-monitoring + Feedback
n=60 Participants
Participants receive web-based sleep hygiene advice + sleep/alcohol diary self-monitoring + sleep/alcohol data feedback
Advice: Once per week for two weeks, participants will come to in-person visits to receive brief web-based sleep hygiene advice.
Self-monitoring: Participants will complete daily web-based sleep and alcohol diaries for two weeks.
Feedback: Participants will receive feedback once per week for two weeks on their sleep and alcohol consumption, using all possible data derived from Fitbit actigraphs and Milo Sensor blood-alcohol trackers.
|
Total
n=120 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
20.9 years
STANDARD_DEVIATION 1.7 • n=93 Participants
|
21.3 years
STANDARD_DEVIATION 1.8 • n=4 Participants
|
21.2 years
STANDARD_DEVIATION 1.7 • n=27 Participants
|
21.2 years
STANDARD_DEVIATION 1.8 • n=483 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=93 Participants
|
16 Participants
n=4 Participants
|
30 Participants
n=27 Participants
|
61 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=93 Participants
|
14 Participants
n=4 Participants
|
30 Participants
n=27 Participants
|
59 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
9 Participants
n=27 Participants
|
19 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
25 Participants
n=93 Participants
|
25 Participants
n=4 Participants
|
51 Participants
n=27 Participants
|
101 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
10 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
9 Participants
n=483 Participants
|
|
Race (NIH/OMB)
White
|
26 Participants
n=93 Participants
|
25 Participants
n=4 Participants
|
45 Participants
n=27 Participants
|
96 Participants
n=483 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
4 Participants
n=483 Participants
|
|
Region of Enrollment
United States
|
30 participants
n=93 Participants
|
30 participants
n=4 Participants
|
60 participants
n=27 Participants
|
120 participants
n=483 Participants
|
PRIMARY outcome
Timeframe: weeks 4 through 12Population: Intention to treat analysis
This will be recorded using the Timeline Follow-back Interview, based on the U.S. Standard Drink Conversion Chart. Upon results entry, the outcome was updated to include the following: data are log-transformed total alcohol drinks consumed over time from Week 4 to Week 12 follow-up, controlling for baseline.
Outcome measures
| Measure |
Advice
n=30 Participants
Participants receive only web-based sleep hygiene advice
Advice: Once per week for two weeks, participants will come to in-person visits to receive brief web-based sleep hygiene advice.
|
Advice + Self-monitoring
n=30 Participants
Participants receive web-based sleep hygiene advice + sleep/alcohol diary self-monitoring
Advice: Once per week for two weeks, participants will come to in-person visits to receive brief web-based sleep hygiene advice.
Self-monitoring: Participants will complete daily web-based sleep and alcohol diaries for two weeks.
|
Advice + Self-monitoring + Feedback
n=60 Participants
Participants receive web-based sleep hygiene advice + sleep/alcohol diary self-monitoring + sleep/alcohol data feedback
Advice: Once per week for two weeks, participants will come to in-person visits to receive brief web-based sleep hygiene advice.
Self-monitoring: Participants will complete daily web-based sleep and alcohol diaries for two weeks.
Feedback: Participants will receive feedback once per week for two weeks on their sleep and alcohol consumption, using all possible data derived from Fitbit actigraphs and Milo Sensor blood-alcohol trackers.
|
|---|---|---|---|
|
Total Alcohol Drinks Consumed Over the 12wk Followup
|
3.07 log-transformed total alcohol drinks
Standard Error 0.13
|
2.95 log-transformed total alcohol drinks
Standard Error 0.12
|
2.96 log-transformed total alcohol drinks
Standard Error 0.09
|
SECONDARY outcome
Timeframe: Baseline, week 4, week 8 and week 12Population: Intention to treat analysis
This is a validated, reliable measure of perceived sleep quality/satisfaction and difficulty initiating/maintaining sleep. Upon results entry, the outcome was updated to reflect the following: Sleep Disturbance Score assessed at Week 4, 8 and 12, controlling for baseline. Scores represent standardized T scores with mean of 50 and a standard deviation of 10. Higher scores, 50 and above, equal greater sleep disturbance. Scores 60 and above are clinically significant. Presented is the least squares mean across assessments.
Outcome measures
| Measure |
Advice
n=30 Participants
Participants receive only web-based sleep hygiene advice
Advice: Once per week for two weeks, participants will come to in-person visits to receive brief web-based sleep hygiene advice.
|
Advice + Self-monitoring
n=30 Participants
Participants receive web-based sleep hygiene advice + sleep/alcohol diary self-monitoring
Advice: Once per week for two weeks, participants will come to in-person visits to receive brief web-based sleep hygiene advice.
Self-monitoring: Participants will complete daily web-based sleep and alcohol diaries for two weeks.
|
Advice + Self-monitoring + Feedback
n=60 Participants
Participants receive web-based sleep hygiene advice + sleep/alcohol diary self-monitoring + sleep/alcohol data feedback
Advice: Once per week for two weeks, participants will come to in-person visits to receive brief web-based sleep hygiene advice.
Self-monitoring: Participants will complete daily web-based sleep and alcohol diaries for two weeks.
Feedback: Participants will receive feedback once per week for two weeks on their sleep and alcohol consumption, using all possible data derived from Fitbit actigraphs and Milo Sensor blood-alcohol trackers.
|
|---|---|---|---|
|
National Institutes of Health Patient-Reported Outcomes Measurement Information System™ (NIH PROMIS™) Sleep Disturbance Score- Least Squares Mean Across Assessments
|
51.39 T-score
Standard Error 0.67
|
49.75 T-score
Standard Error 0.65
|
49.46 T-score
Standard Error 0.45
|
SECONDARY outcome
Timeframe: Baseline, week 4, week 8 and week 12Population: Intention to treat analysis
National Institutes of Health Patient-Reported Outcomes Measurement Information System™ (NIH PROMIS™) Sleep-Related Impairment Score assessed at Week 4, 8, and 12, controlling for baseline. Scores represent standardized T scores with mean of 50 and a standard deviation of 10. Higher scores, 50 and above, equal greater sleep-related impairment. Scores 60 and above are clinically significant. Presented is the least squares mean across assessments.
Outcome measures
| Measure |
Advice
n=30 Participants
Participants receive only web-based sleep hygiene advice
Advice: Once per week for two weeks, participants will come to in-person visits to receive brief web-based sleep hygiene advice.
|
Advice + Self-monitoring
n=30 Participants
Participants receive web-based sleep hygiene advice + sleep/alcohol diary self-monitoring
Advice: Once per week for two weeks, participants will come to in-person visits to receive brief web-based sleep hygiene advice.
Self-monitoring: Participants will complete daily web-based sleep and alcohol diaries for two weeks.
|
Advice + Self-monitoring + Feedback
n=60 Participants
Participants receive web-based sleep hygiene advice + sleep/alcohol diary self-monitoring + sleep/alcohol data feedback
Advice: Once per week for two weeks, participants will come to in-person visits to receive brief web-based sleep hygiene advice.
Self-monitoring: Participants will complete daily web-based sleep and alcohol diaries for two weeks.
Feedback: Participants will receive feedback once per week for two weeks on their sleep and alcohol consumption, using all possible data derived from Fitbit actigraphs and Milo Sensor blood-alcohol trackers.
|
|---|---|---|---|
|
National Institutes of Health Patient-Reported Outcomes Measurement Information System™ (NIH PROMIS™) Sleep-Related Impairment Score - Least Squares Mean Across Assessments
|
57.80 T-score
Standard Error 0.90
|
57.05 T-score
Standard Error 0.88
|
54.89 T-score
Standard Error 0.62
|
SECONDARY outcome
Timeframe: 2 weeksIn this survey, participants will rate their satisfaction associated with each intervention component using a 5-point Likert-type scale. Upon results entry, the outcome was corrected to reflect the following: the overall treatment satisfaction uses the mean of questions on a 5-point Likert-type scale from 0 to 4, with higher scores indicating greater satisfaction.
Outcome measures
| Measure |
Advice
n=29 Participants
Participants receive only web-based sleep hygiene advice
Advice: Once per week for two weeks, participants will come to in-person visits to receive brief web-based sleep hygiene advice.
|
Advice + Self-monitoring
n=29 Participants
Participants receive web-based sleep hygiene advice + sleep/alcohol diary self-monitoring
Advice: Once per week for two weeks, participants will come to in-person visits to receive brief web-based sleep hygiene advice.
Self-monitoring: Participants will complete daily web-based sleep and alcohol diaries for two weeks.
|
Advice + Self-monitoring + Feedback
n=60 Participants
Participants receive web-based sleep hygiene advice + sleep/alcohol diary self-monitoring + sleep/alcohol data feedback
Advice: Once per week for two weeks, participants will come to in-person visits to receive brief web-based sleep hygiene advice.
Self-monitoring: Participants will complete daily web-based sleep and alcohol diaries for two weeks.
Feedback: Participants will receive feedback once per week for two weeks on their sleep and alcohol consumption, using all possible data derived from Fitbit actigraphs and Milo Sensor blood-alcohol trackers.
|
|---|---|---|---|
|
End of Treatment Satisfaction Survey Score
|
3.45 score on a scale
Standard Error 0.74
|
3.48 score on a scale
Standard Error 0.57
|
3.60 score on a scale
Standard Error 0.56
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 4 weeksThe difference between the mean reaction time and the stop-signal delay on the stop-signal test. Upon results entry, the following was added: This outcome will be explored as a potential mechanism of sleep intervention condition effects on the primary outcome of total drinks consumed. If there is a significant effect of condition on total drinks, the analysis of stop signal reaction time will be conducted. Due to COVID-19, this assessment was stopped since it could not be administered virtually. Since there was no effect of condition on total drinks consumed, an analysis of this outcome as a potential mechanism was not undertaken. The following represents the number of participants in each condition had this assessment conducted prior to COVID.
Outcome measures
| Measure |
Advice
n=30 Participants
Participants receive only web-based sleep hygiene advice
Advice: Once per week for two weeks, participants will come to in-person visits to receive brief web-based sleep hygiene advice.
|
Advice + Self-monitoring
n=30 Participants
Participants receive web-based sleep hygiene advice + sleep/alcohol diary self-monitoring
Advice: Once per week for two weeks, participants will come to in-person visits to receive brief web-based sleep hygiene advice.
Self-monitoring: Participants will complete daily web-based sleep and alcohol diaries for two weeks.
|
Advice + Self-monitoring + Feedback
n=60 Participants
Participants receive web-based sleep hygiene advice + sleep/alcohol diary self-monitoring + sleep/alcohol data feedback
Advice: Once per week for two weeks, participants will come to in-person visits to receive brief web-based sleep hygiene advice.
Self-monitoring: Participants will complete daily web-based sleep and alcohol diaries for two weeks.
Feedback: Participants will receive feedback once per week for two weeks on their sleep and alcohol consumption, using all possible data derived from Fitbit actigraphs and Milo Sensor blood-alcohol trackers.
|
|---|---|---|---|
|
Stop-signal Reaction Time
|
22 Participants
|
19 Participants
|
43 Participants
|
Adverse Events
Advice
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Advice + Self-monitoring
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Advice + Self-monitoring + Feedback
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