Recovery Enhancement and Sleep Training

NCT02982239 | Completed Results

• 1 other identifier: 1605615210
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

Evidence suggests that student athletes frequently experience sleep problems and are aware of the impact of sleep loss on mental and physical outcomes. As such, student athletes are motivated to improve sleep quality in order to improve their outcomes for overall athletic performance. This study will consist of two parts. The first part will be a survey. Fall athletes arrive in the summer, and Part 1 will invite 200 of these athletes to complete a survey within the first week of their arrival on campus. The survey will assess multiple domains of student-athlete health, namely, sleep duration and quality, mood and depression, stress, and mental and physical well-being. The responses to the survey will be confidential, and students will be compensated for the survey. At the end of the semester, students will be invited to complete the survey again. Part 2 is an intervention. 40 of the 200 students will be chosen to participate in the intervention, based on predetermined criteria. The intervention will include an information session where students may ask questions. Students will be sent text message reminders about adherence to the program and will be asked to monitor their sleep quality with sleep diaries. The intervention will consist of the half of the 40 chosen students, (20 students), who will be provided with blue blocking glasses, a bright light-emitting diode (LED) light, and a fit bit. Please note that all of these items are commercially available and are not meant to be used to treat or prevent human illness nor injury and do not require FDA oversight. The blue-blocking glasses will ensure that blue light from electronic devices will not interfere with circadian rhythm or sleep onset, and allow students to fall asleep earlier. The bright LED light will provide bright blue light in the morning to help students wake and an amber light to promote earlier bedtimes. The Fitbit will estimate sleep and physical activity as well as adherence to the program.

Conditions

Sleep; Performance; Mental Health; Stress; Anxiety

Outcome Measures

Primary Outcomes (5)

• Pittsburgh Sleep Quality Index ( PSQI)

  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.

  Change from baseline to post-intervention, around 10 weeks after baseline

• Insomnia Severity Index (ISI)

  Change 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)

  Change from baseline to post intervention, around 10 weeks after baseline

• Centers for Disease Control (CDC)l and Prevention Health-Related Quality of Life Scale (HRQOL)

  Change 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.

  Change from baseline to post intervention, around 10 weeks after baseline

• Centers for Epidemiological Studies Depression Scale (CESD)

  Change 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.

  Change from baseline to post intervention, around 10 weeks after baseline

• Perceived Stress Scale (PSS)

  Change 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.

  Change from baseline to post intervention, around 10 weeks after baseline

Study Arms (2)

Sleep Intervention

OTHER

N=20 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

Behavioral: Sleep Diary; Device: Fitness tracker; Other: Information Session; Behavioral: Text messages

Sleep Intervention plus Tech

OTHER

N=20 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.

Behavioral: Sleep Diary; Device: Fitness tracker; Device: Blue-Blocking Glasses; Device: LED light; Other: Information Session; Behavioral: Text messages

Interventions

Sleep Diary BEHAVIORAL

All 40 chosen students will be provided a link to complete a daily sleep diary for 10 weeks. Sleep diary will assess activity before bed, bedtime, time to fall asleep, number of awakenings, time awake after sleep onset, time out of bed, time of final awakening, perceived sleep quality. Diary also asks about naps taken during the day, caffeine and tobacco consumption, and an additional space for open-ended comments from the participant.

Sleep Intervention; Sleep Intervention plus Tech

Fitness tracker DEVICE

All 40 chosen students will receive a fitness tracker. The fit bit will estimate sleep and physical activity as well as adherence to the program. participants will have access to their own data. Data will also be monitored from the lab using Fitabase which provides access to day, hour, and minute-level resolution of data for steps taken, intensity class, calories burned, and sleep (length, movement, and quality).

Sleep Intervention; Sleep Intervention plus Tech

Blue-Blocking Glasses DEVICE

Half of the 40 chosen students (N=20) will be provided with blue blocking glasses. The blue-blocking glasses will ensure that blue light from electronic devices will not interfere with circadian rhythm or sleep onset, and allow students to fall asleep earlier.

Sleep Intervention plus Tech

LED light DEVICE

Half of the 40 chosen students (N=20) will be provided with a bright LED light. The bright LED light will provide bright blue light in the morning to help students wake and an amber light to promote earlier bedtimes.

Sleep Intervention plus Tech

Information Session OTHER

all 40 participants will attend a 1-hour information session about sleep delivered by the PIs, to be followed by a 1-hour Q\&A period. Peer educators will receive and extra 1-hour training session on how to handle questions and when to refer back to the PIs.

Also known as: Educational session

Sleep Intervention; Sleep Intervention plus Tech

Text messages BEHAVIORAL

All participants will receive text messages in the evening that will include adherence reminders, encouraging statements, and tips for improving sleep. Messages will be randomized, with no more than 3 messages of any type per week. Messages will serve as a cue to action without being overly repetitive or predictable.

Sleep Intervention; Sleep Intervention plus Tech

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Willingness to participate
• Participation as a student-athlete during the entirety of their season
• No medical conditions that would preclude them from participating (assessed by self-report)
• Age ≥18 years

You may not qualify if:

• Freshmen

Sponsors & Collaborators

• University of Arizona: lead
• National Collegiate Athletic Association - NCAA: collaborator

MeSH Terms

Conditions

Psychological Well-Being; Anxiety Disorders

Interventions

Fitness Trackers

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior; Mental Disorders

Intervention Hierarchy (Ancestors)

Diagnostic Equipment; Equipment and Supplies; Wearable Electronic Devices; Electrical Equipment and Supplies

Limitations and Caveats

Since this is considered a pilot study and is likely underpowered, the primary outcomes were assessed for change over time.

Results Point of Contact

• Title: Dr. Michael Grandner
• Organization: Sleep and Health Research Program - University of Arizona

grandner@psychiatry.arizona.edu

5206260105

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2016
• First Posted: December 5, 2016
• Study Start: June 1, 2016
• Primary Completion: January 4, 2017
• Study Completion: January 5, 2017
• Last Updated: July 19, 2019
• Results First Posted: July 19, 2019

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will not share