Trial Outcomes & Findings for Recovery Enhancement and Sleep Training (NCT NCT02982239)
NCT ID: NCT02982239
Last Updated: 2019-07-19
Results Overview
Change in Pittsburgh Sleep Quality Index (PSQI) score at the end of the 10-week intervention. The PSQI global score has a possible range of 0-21 points. A total score of 5 or above indicates overall poor sleep quality.
COMPLETED
NA
40 participants
Change from baseline to post-intervention, around 10 weeks after baseline
2019-07-19
Participant Flow
Student-athletes were recruited over the summer and through the first 2 weeks of the 2015 Fall semester, as they arrived on campus. Recruitment was accomplished through flyers, referrals from athletics staff, and in-person recruitment among athletes at on campus athletic facilities.
All students who completed the survey were eligible for the intervention study, though selection was targeted to those with sleep complaints.
Participant milestones
| Measure |
Intervention- No Tech
Participants received fitness tracker, information session, a link to complete a daily sleep diary, intermittent text messages that included adherence reminders, encouraging statements, and tips for improving sleep. Daily monitoring with sleep diaries, daily monitoring of sleep tracker sync activity and regret lottery for 10 weeks
|
Intervention -Tech
Participants received fitness tracker, LED light, Blue-blocking glasses along with information session, a link to complete a daily sleep diary, intermittent text messages that included adherence reminders, encouraging statements, and tips for improving sleep. Daily monitoring with sleep diaries, daily monitoring of sleep tracker sync activity and regret lottery for 10 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
|
Overall Study
COMPLETED
|
17
|
18
|
|
Overall Study
NOT COMPLETED
|
3
|
2
|
Reasons for withdrawal
| Measure |
Intervention- No Tech
Participants received fitness tracker, information session, a link to complete a daily sleep diary, intermittent text messages that included adherence reminders, encouraging statements, and tips for improving sleep. Daily monitoring with sleep diaries, daily monitoring of sleep tracker sync activity and regret lottery for 10 weeks
|
Intervention -Tech
Participants received fitness tracker, LED light, Blue-blocking glasses along with information session, a link to complete a daily sleep diary, intermittent text messages that included adherence reminders, encouraging statements, and tips for improving sleep. Daily monitoring with sleep diaries, daily monitoring of sleep tracker sync activity and regret lottery for 10 weeks.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
3
|
2
|
Baseline Characteristics
Recovery Enhancement and Sleep Training
Baseline characteristics by cohort
| Measure |
Intervention
n=20 Participants
Participants received fitness tracker, information session, a link to complete a daily sleep diary, intermittent text messages that included adherence reminders, encouraging statements, and tips for improving sleep. Daily monitoring with sleep diaries, daily monitoring of sleep tracker sync activity and regret lottery for 10 weeks
|
Intervention -Tech
n=20 Participants
Participants received fitness tracker, LED light, Blue-blocking glasses along with information session, a link to complete a daily sleep diary, intermittent text messages that included adherence reminders, encouraging statements, and tips for improving sleep. Daily monitoring with sleep diaries, daily monitoring of sleep tracker sync activity and regret lottery for 10 weeks.
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
20.56 years
STANDARD_DEVIATION 0.97 • n=93 Participants
|
20.55 years
STANDARD_DEVIATION 0.93 • n=4 Participants
|
20.55 years
STANDARD_DEVIATION 0.94 • n=27 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=93 Participants
|
13 Participants
n=4 Participants
|
27 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
13 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Change from baseline to post-intervention, around 10 weeks after baselineChange in Pittsburgh Sleep Quality Index (PSQI) score at the end of the 10-week intervention. The PSQI global score has a possible range of 0-21 points. A total score of 5 or above indicates overall poor sleep quality.
Outcome measures
| Measure |
Intervention
n=17 Participants
Participants received fitness tracker, information session, a link to complete a daily sleep diary, intermittent text messages that included adherence reminders, encouraging statements, and tips for improving sleep. Daily monitoring with sleep diaries, daily monitoring of sleep tracker sync activity and regret lottery for 10 weeks
|
Intervention -Tech
n=18 Participants
Participants received fitness tracker, LED light, Blue-blocking glasses along with information session, a link to complete a daily sleep diary, intermittent text messages that included adherence reminders, encouraging statements, and tips for improving sleep. Daily monitoring with sleep diaries, daily monitoring of sleep tracker sync activity and regret lottery for 10 weeks.
|
|---|---|---|
|
Pittsburgh Sleep Quality Index ( PSQI)
Baseline
|
4.941176471 units on a scale
Standard Deviation 2.9041046
|
6.555555556 units on a scale
Standard Deviation 3.329409455
|
|
Pittsburgh Sleep Quality Index ( PSQI)
Post-intervention
|
4.647058824 units on a scale
Standard Deviation 2.84914848
|
5.833333333 units on a scale
Standard Deviation 2.7917947
|
PRIMARY outcome
Timeframe: Change from baseline to post intervention, around 10 weeks after baselineChange Insomnia Severity Index (ISI) score at the end of 10-week intervention. The Insomnia Severity Index is a frequently-used questionnaire to measure insomnia symptoms. Total score categories: 0-7 = No clinically significant insomnia 8-14 = Subthreshold insomnia 15-21 = Clinical insomnia (moderate severity) 22-28 = Clinical insomnia (severe)
Outcome measures
| Measure |
Intervention
n=17 Participants
Participants received fitness tracker, information session, a link to complete a daily sleep diary, intermittent text messages that included adherence reminders, encouraging statements, and tips for improving sleep. Daily monitoring with sleep diaries, daily monitoring of sleep tracker sync activity and regret lottery for 10 weeks
|
Intervention -Tech
n=18 Participants
Participants received fitness tracker, LED light, Blue-blocking glasses along with information session, a link to complete a daily sleep diary, intermittent text messages that included adherence reminders, encouraging statements, and tips for improving sleep. Daily monitoring with sleep diaries, daily monitoring of sleep tracker sync activity and regret lottery for 10 weeks.
|
|---|---|---|
|
Insomnia Severity Index (ISI)
Post-intervention
|
5.176470588 scores on a scale
Standard Deviation 4.034775305
|
5.266666667 scores on a scale
Standard Deviation 3.954503159
|
|
Insomnia Severity Index (ISI)
Baseline
|
5.529411765 scores on a scale
Standard Deviation 4.862068066
|
7.5 scores on a scale
Standard Deviation 3.944467458
|
PRIMARY outcome
Timeframe: Change from baseline to post intervention, around 10 weeks after baselineChange in CDC Health-Related Quality of Life Scale (HRQOL) score at the end of 10-week intervention. Health-related quality of life (HRQOL) is an individual's or a group's perceived physical and mental health over time. Unhealthy days are an estimate of the overall number of days during the previous 30 days when the respondent felt that either his or her physical or mental health was not good. Healthy days are the positive complementary form of unhealthy days. Healthy days estimates the number of recent days when a person's physical and mental health was good (or better) and is calculated by subtracting the number of unhealthy days from 30 days.
Outcome measures
| Measure |
Intervention
n=17 Participants
Participants received fitness tracker, information session, a link to complete a daily sleep diary, intermittent text messages that included adherence reminders, encouraging statements, and tips for improving sleep. Daily monitoring with sleep diaries, daily monitoring of sleep tracker sync activity and regret lottery for 10 weeks
|
Intervention -Tech
n=18 Participants
Participants received fitness tracker, LED light, Blue-blocking glasses along with information session, a link to complete a daily sleep diary, intermittent text messages that included adherence reminders, encouraging statements, and tips for improving sleep. Daily monitoring with sleep diaries, daily monitoring of sleep tracker sync activity and regret lottery for 10 weeks.
|
|---|---|---|
|
Centers for Disease Control (CDC)l and Prevention Health-Related Quality of Life Scale (HRQOL)
unhealthy mental health days Baseline
|
6.176470588 Days out of 30
Standard Deviation 10.30919065
|
7.555555556 Days out of 30
Standard Deviation 8.958874813
|
|
Centers for Disease Control (CDC)l and Prevention Health-Related Quality of Life Scale (HRQOL)
unhealthy Physical health days Baseline
|
5.411764706 Days out of 30
Standard Deviation 9.695738906
|
3.944444444 Days out of 30
Standard Deviation 6.803737919
|
|
Centers for Disease Control (CDC)l and Prevention Health-Related Quality of Life Scale (HRQOL)
unhealthy mental health days Post-Intervention
|
6.411764706 Days out of 30
Standard Deviation 8.000459546
|
4.611111111 Days out of 30
Standard Deviation 5.699730529
|
|
Centers for Disease Control (CDC)l and Prevention Health-Related Quality of Life Scale (HRQOL)
unhealthy physical health days Post-Intervention
|
6.352941176 Days out of 30
Standard Deviation 9.512762325
|
6.833333333 Days out of 30
Standard Deviation 9.173170598
|
PRIMARY outcome
Timeframe: Change from baseline to post intervention, around 10 weeks after baselineChange in Centers for Epidemiological Studies Depression Scale (CESD) score at the end of 10-week intervention. Possible range of scores is zero to 60, with the higher scores indicating the presence of more symptomatology.
Outcome measures
| Measure |
Intervention
n=17 Participants
Participants received fitness tracker, information session, a link to complete a daily sleep diary, intermittent text messages that included adherence reminders, encouraging statements, and tips for improving sleep. Daily monitoring with sleep diaries, daily monitoring of sleep tracker sync activity and regret lottery for 10 weeks
|
Intervention -Tech
n=18 Participants
Participants received fitness tracker, LED light, Blue-blocking glasses along with information session, a link to complete a daily sleep diary, intermittent text messages that included adherence reminders, encouraging statements, and tips for improving sleep. Daily monitoring with sleep diaries, daily monitoring of sleep tracker sync activity and regret lottery for 10 weeks.
|
|---|---|---|
|
Centers for Epidemiological Studies Depression Scale (CESD)
CESD total score Baseline
|
8.294117647 score on a scale
Standard Deviation 6.45914764
|
10.16666667 score on a scale
Standard Deviation 7.957608272
|
|
Centers for Epidemiological Studies Depression Scale (CESD)
CESD total score Post-Intervention
|
9.470588235 score on a scale
Standard Deviation 8.147987843
|
7.333333333 score on a scale
Standard Deviation 6.962082177
|
PRIMARY outcome
Timeframe: Change from baseline to post intervention, around 10 weeks after baselineChange in Perceived Stress Scale (PSS) score at the end of the 10-week intervention.The PSS is comprised of 14 items intended to measure how unpredictable, uncontrollable, and overloaded individuals find their life circumstances.Participants rate items on a 5-point Likert scale, ranging from 0 - "Never" to 4 - "Very often." Scores range from 0-56 higher scores indicate greater perceived stress.
Outcome measures
| Measure |
Intervention
n=17 Participants
Participants received fitness tracker, information session, a link to complete a daily sleep diary, intermittent text messages that included adherence reminders, encouraging statements, and tips for improving sleep. Daily monitoring with sleep diaries, daily monitoring of sleep tracker sync activity and regret lottery for 10 weeks
|
Intervention -Tech
n=18 Participants
Participants received fitness tracker, LED light, Blue-blocking glasses along with information session, a link to complete a daily sleep diary, intermittent text messages that included adherence reminders, encouraging statements, and tips for improving sleep. Daily monitoring with sleep diaries, daily monitoring of sleep tracker sync activity and regret lottery for 10 weeks.
|
|---|---|---|
|
Perceived Stress Scale (PSS)
Baseline
|
21.52941176 score on a scale
Standard Deviation 7.072107598
|
21.27777778 score on a scale
Standard Deviation 5.706606652
|
|
Perceived Stress Scale (PSS)
Post-intervention
|
23.05882353 score on a scale
Standard Deviation 7.386394488
|
19.11111111 score on a scale
Standard Deviation 7.379533613
|
Adverse Events
Intervention
Intervention -Tech
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Michael Grandner
Sleep and Health Research Program - University of Arizona
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place