Clinical trial NCT02982239: Recovery Enhancement and Sleep Training
Official title: Recovery Enhancement and Sleep Training (REST): Sleep and Mental Well-Being in Student Athletes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep
Performance
Mental Health
Stress
Anxiety
Lead sponsor: University of Arizona
Sponsor class: OTHER
Collaborators: name: National Collegiate Athletic Association - NCAA
First posted: 2016-12-05
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Detailed description: Student athletes face many challenges to their ability to maintain healthy mental and physical well-being. The college experience is associated with a number of physiologic, social, and environmental stressors that can exert long-term effects on an individual's future health and quality of life. In addition, unique demands of student-athletes, including academic, physical performance, scheduling, and travel demands, all represent additional stressors that interact to produce in poorer outcomes.

Insufficient sleep duration and poor sleep quality have been increasingly identified as important risk factors for physical and mental well-being, especially among young adults. For example, insufficient and/or poor quality sleep is strongly associated with the development of cardiometabolic disease risk factors, obesity, depression, anxiety disorders, alcohol use, other substance use, poorer academic performance, and reduced mental well-being, in addition to poorer athletic performance.

Data from a recent PAC12 conference report shows that 2/3 of students indicated that lack of flexible time is the hardest thing about being an athlete, more than academic work. Further, students identified sleep as the first thing that their athletic time commitments kept them from doing, 77% felt that they got less sleep than non-athletes, and \>50% indicated that they would use an extra hour to catch up on sleep. In 2015 data from the American College Health Association, (1) 29% of student athletes report significant sleep difficulties, (2) 40% reported getting enough sleep on only ≤3 nights, (3) 10% reported no problems with daytime sleepiness, (4) \>15% reported sleepiness to be at least "a big problem," (5) \>25% reported extreme difficulty falling asleep ≥3 nights/week (consistent with a diagnosis of insomnia), and (6) \>50% reported that sleep problems impacted academic performance. Thus, student-athletes frequently experience sleep problems, they recognize the impact of sleep loss, and they are likely motivated to improve sleep. These data are consistent with data from professional athletes, whose overall sleep quality is poorer than non-athletes.

Taken together, sleep is an aspect of health that is implicated in many of the most salient mental and physical outcomes among college athletes. Despite this, obtaining sufficient sleep represents one of the greatest challenges facing student athletes. No programmatic approaches have been able to address this problem.

Accordingly, the proposed study aims to develop and assess the benefits of a novel sleep health intervention targeted at student-athletes. This intervention will be assessed with and without the assistance of tools to aid in tracking sleep and adjusting to difficult schedules in order to evaluate the utility of those approaches.

The purpose of this research study is to develop and assess the benefits of a novel sleep health intervention targeted at student-athletes.

Overall objectives AIM 1: Assess cross-sectional relationships among sleep, circadian preference, and outcomes including overall mental health, stress, mood, anxiety, social functioning, and physical well-being.

AIM 2: Determine whether a simple sleep health intervention, with and without the aid of technology, is associated with improvements in mental and physical well-being.

Primary outcome variable(s) AIM 1: depression score, stress score, mental well-being score, anxiety score, and physical well-being score AIM 2: changes in AIM 1 outcomes Secondary outcome variable(s) Academic stress, physical performance, substance use, health behaviors, soft tissue injuries, missed practices, academic performance

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Freshmen

Primary outcomes:
measure: Pittsburgh Sleep Quality Index ( PSQI)
timeFrame: Change from baseline to post-intervention, around 10 weeks after baseline
measure: Insomnia Severity Index (ISI)
timeFrame: Change from baseline to post intervention, around 10 weeks after baseline
measure: Centers for Disease Control (CDC)l and Prevention Health-Related Quality of Life Scale (HRQOL)
timeFrame: Change from baseline to post intervention, around 10 weeks after baseline
measure: Centers for Epidemiological Studies Depression Scale (CESD)
timeFrame: Change from baseline to post intervention, around 10 weeks after baseline
measure: Perceived Stress Scale (PSS)
timeFrame: Change from baseline to post intervention, around 10 weeks after baseline
Secondary outcomes:
Other outcomes:
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