Project REST: Club Sports

NCT07103759 | Withdrawn

• 1 other identifier: 2002361146
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Poor Quality Sleep

Keywords

Educational Intervention; Insomnia; Daytime Sleepiness; College Students; Athletes; Club Sports; Sleep Duration; Sleep Quality; Stress; Academic Stress

Outcome Measures

Primary Outcomes (7)

• Changes in Pittsburgh Sleep Quality Index (PSQI)

  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)

  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)

  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

  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)

  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)

  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.

  Change from baseline to post-intervention, around 6 weeks after baseline

• Changes in Generalized Anxiety Disorder 7-item Scale (GAD-7)

  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

Study Arms (2)

Project REST Platform+refrain from caffeine technique

EXPERIMENTAL

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.

Behavioral: Refrain from caffeine techniques; Behavioral: Project REST Platform

Project REST Platform ONLY

ACTIVE COMPARATOR

N =25 participants will consist of participants using just the Project REST platform (control group)

Behavioral: Project REST Platform

Interventions

Refrain from caffeine techniques BEHAVIORAL

Participants will be asked to refrain from drinking caffeinated beverages in the late afternoon and evening.

Project REST Platform+refrain from caffeine technique

Project REST Platform BEHAVIORAL

Participants will use the Project REST platform

Project REST Platform ONLY; Project REST Platform+refrain from caffeine technique

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
• Currently active on the team roster
• Age 18 years or older

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Arizona: lead

Study Sites (1)

University of Arizona

Tucson, Arizona, 85724, United States

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Disorders of Excessive Somnolence

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Michael A Grandner, PhD, MTR

  University of Arizona

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: N=50 participants will be randomized to one of two groups. Group 1\| 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. Group 2\|(N=25) will consist of participants using just the Project REST platform (control group)

Study Record Dates

• First Submitted: February 10, 2020
• First Posted: August 5, 2025
• Study Start: February 24, 2020
• Primary Completion: February 24, 2021
• Study Completion: February 24, 2021
• Last Updated: August 11, 2025

Record last verified: 2025-08

Locations

US (1)