Viewing Study NCT07103759


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Ignite Modification Date: 2025-12-31 @ 6:41 PM
Study NCT ID: NCT07103759
Status: WITHDRAWN
Last Update Posted: 2025-08-11
First Post: 2020-02-10
Is NOT Gene Therapy: True
Has Adverse Events: False

Brief Title: Project REST: Club Sports
Sponsor: University of Arizona
Organization:

Study Overview

Official Title: Project REST: Club Sports
Status: WITHDRAWN
Status Verified Date: 2025-08
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Due to COVID 2020 pandemic, unable to start recruitment.
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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 given to 15 clubs early into the spring semester (this time will allow poor sleep habits and quality a chance to manifest). Of the individuals that participate, a 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 at the end of the semester, students will be invited to complete the survey again Part 2 is an intervention. 50 of the participants will be chosen to partake in the intervention, based on predetermined criteria. The intervention will include an information session where students may ask questions. Students will be sent brief email reminders about adherence to the program and will be asked to monitor their sleep quality with sleep diaries. Half of the 50 chosen (25 students) will be asked to refrain from drinking caffeinated drinks (coffee, energy drinks, soft drinks, etc.) late in the afternoon (6pm and on). Caffeine can delay the bodies circadian rhythm and reduce the total sleep time.
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 Oversight

Has Oversight DMC: False
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: