- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07103759
- Original Trial
Project REST: Club Sports
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Over the past few years, the effects of a poor sleep in varsity level, collegiate student-athletes has been attributed to a broad range of physiologic, social, and environmental pressures, including long hours, additional stress, travel burden, and other sources. Studies have shown that chronic sleep deprivation and inadequate sleep are 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.
In data from student-athletes in the American College Health Association from 2011-2014, when asked about access to health-related information, sleep was one of the most infrequently-provided domains of information. Yet, more than half of the student-athletes reported that they wanted more information about sleep, more than nearly all other categories of information. In addition, sleep problems were common, such that 19.8% reported that sleep difficulties had been "traumatic or very difficult," 21.8% reported "extreme difficulty" falling asleep ≥3 nights/week, and 57.0% indicated that they got enough sleep to feel rested on ≤3 nights/week (20.4% ≤1 day/week). Regarding daytime consequences, 60.9% reported extreme tiredness ≥3 days/week and 17.7% reported that sleep difficulties interfered with academics. Additional data from this cohort shows that poor sleep was also associated with lower academic performance, worse mental health, increased substance use, and increased risky behaviors while drinking.
For this reason, we developed Project REST (Recovery Enhancement and Sleep Training) to be a program that can improve sleep among student athletes, despite the many situational constraints. The original Project REST study pilot study included educational, tracking, support, and motivational enhancement. This combination produced strong results, including 77 minutes increased sleep duration, 10% increased sleep efficiency, 55% improvement in sleep latency, 40% improvement in insomnia symptoms, 80% reduction in drowsy driving, and 21% improved overall energy level.
The University of Arizona has many men and women competing in Division 1 athletics in the public eye, but there are many other student athletes that also participate in sport. According to data collected from UA, there are 35 athletics organizations-- clubs that in most cases are not recognized by the National Collegiate Athletic Association (for example, rugby, lacrosse, etc.). With more than 1,000 UA student athletes competing regionally, nationally, and occasionally in cities around the world, the likelihood of similar poor sleep habits and diminished sleep quality are high. Using the platform of Project REST, the goal of this new study, Project REST: Club Sports, will be to inform, educate, and monitor a small pool of club sports student athletes and implementing the data collected into a program that can be dispersed to a larger audience.
Study Type
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Arizona
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Tucson, Arizona, United States, 85724
- University of Arizona
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Willingness to participate
- Currently active on the team roster
- Age 18 years or older
Exclusion Criteria:
- Participant is under 18 years old
- Not currently active on the team roster
- Have medical conditions that the PI considers would preclude them from participating.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Project REST Platform+refrain from caffeine technique
N =25 participants will use the Project REST platform and also use one of the learned techniques.
The applied technique they will be asked to complete will be to refrain from drinking caffeinated drinks late in the afternoon.
|
Participants will be asked to refrain from drinking caffeinated beverages in the late afternoon and evening.
Participants will use the Project REST platform
|
|
Active Comparator: Project REST Platform ONLY
N =25 participants will consist of participants using just the Project REST platform (control group)
|
Participants will use the Project REST platform
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Changes in Pittsburgh Sleep Quality Index (PSQI)
Time Frame: Change from baseline to post-intervention, around 6 weeks after baseline
|
Change in Pittsburgh Sleep Quality Index (PSQI) score at the end of the 6-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 6 weeks after baseline
|
|
Changes in Insomnia Severity Index (ISI)
Time Frame: Change from baseline to post-intervention, around 6 weeks after baseline
|
Change Insomnia Severity Index (ISI) score at the end of 6-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 6 weeks after baseline
|
|
Changes in Center for Disease Control (CDC) and Prevention Health-Related Quality of Life Scale (HRQOL) Score (Unhealthy Days)
Time Frame: Change from baseline to post-intervention, around 6 weeks after baseline
|
Change in CDC Health-Related Quality of Life Scale (HRQOL) score at the end of 6-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.
The minimum number of unhealthy days is 0 and the maximum is 30.
A higher score means more unhealthy days, a worse outcome.
|
Change from baseline to post-intervention, around 6 weeks after baseline
|
|
Changes in Center for Disease Control (CDC) and Prevention Health-Related Quality of Life Scale (HRQOL) Healthy Days
Time Frame: Change from baseline to post-intervention, around 6 weeks after baseline
|
Change in healthy days from the CDC Health-Related Quality of Life Scale (HRQOL) at the end of 6-week intervention. Health-related quality of life (HRQOL) is an individual's or a group's perceived physical and mental health over time. 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.The minimum number of healthy days is 0 and the maximum is 30. A higher number of healthy days is a better outcome. |
Change from baseline to post-intervention, around 6 weeks after baseline
|
|
Changes in Centers for Epidemiological Studies Depression (CESD)
Time Frame: Change from baseline to post-intervention, around 6 weeks after baseline
|
Change in Centers for Epidemiological Studies Depression Scale (CESD) score at the end of 6-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 6 weeks after baseline
|
|
Changes in Perceived Stress Scale (PSS)
Time Frame: Change from baseline to post-intervention, around 6 weeks after baseline
|
Change in Perceived Stress Scale (PSS) score at the end of the 6-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.
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Change from baseline to post-intervention, around 6 weeks after baseline
|
|
Changes in Generalized Anxiety Disorder 7-item Scale (GAD-7)
Time Frame: Change from baseline to post-intervention, around 6 weeks after baseline
|
Change in GAD-7 at the end of the 6-week intervention which is a self-reported questionnaire for screening and severity measuring of generalized anxiety disorder.
It contains 7 items with answers ranging from "Not at all" to "Nearly every day".
|
Change from baseline to post-intervention, around 6 weeks after baseline
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Michael A Grandner, PhD, MTR, University of Arizona
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2002361146
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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