Poor Quality SleepNCT07103759
Project REST: Club Sports
A study testing Refrain from caffeine techniques and Project REST Platform in people with Poor Quality Sleep, run by University of Arizona at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Poor Quality Sleep
- What is being tested?
- Refrain from caffeine techniques and Project REST Platform
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Feb 2020to 24 Feb 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Willingness to participate
- Currently active on the team roster
- Age 18 years or older
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Poor Quality Sleep
- Being tested
- Refrain from caffeine techniques, Project REST Platform
- Keywords
- Educational Intervention, Insomnia, Daytime Sleepiness, College Students, Athletes, Club Sports, Sleep Duration, Sleep Quality, Stress, Academic Stress
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Disorders of Excessive Somnolence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Refrain from caffeine techniquesBehavioural
Participants will be asked to refrain from drinking caffeinated beverages in the late afternoon and evening.
Project REST PlatformBehavioural
Participants will use the Project REST platform
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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) Receives: Behavioral: Project REST Platform |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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".
Measured: Change from baseline to post-intervention, around 6 weeks after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2025
- Study start24 Feb 2020 (estimated)
- Primary completion24 Feb 2021 (estimated)
- Study completion24 Feb 2021 (estimated)
Why it stopped: Due to COVID 2020 pandemic, unable to start recruitment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Poor Quality SleepStudies of the same condition, open and under way.
- More trials run by University of ArizonaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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)
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, MICHAEL A GRANDNER, University of Arizona
- Investigators
- Michael A Grandner, PhD, MTR, Principal investigator, University of Arizona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07103759
- Sponsor's protocol ID
- 2002361146
- Status last verified
- Aug 2025
- First submitted
- 10 Feb 2020
- Last updated
- 11 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Project REST: Club Sports
- ClinicalTrials.gov ID
- NCT07103759
- Acronym / sponsor ID
- 2002361146
- Conditions
- Poor Quality Sleep
- Keywords
- Educational Intervention, Insomnia, Daytime Sleepiness, College Students, Athletes, Club Sports, Sleep Duration, Sleep Quality
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Due to COVID 2020 pandemic, unable to start recruitment.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Study start
- 24 Feb 2020 (estimated)
- Primary completion
- 24 Feb 2021 (estimated)
- Study completion
- 24 Feb 2021 (estimated)
- First posted
- 5 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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)
| Arm | Type | Receives |
|---|---|---|
| Project REST Platform+refrain from caffeine technique | Experimental | Behavioral: Refrain from caffeine techniques, Behavioral: Project REST PlatformN =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. |
| Project REST Platform ONLY | Active comparator | Behavioral: Project REST PlatformN =25 participants will consist of participants using just the Project REST platform (control group) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Willingness to participate
- Currently active on the team roster
- Age 18 years or older
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Refrain from caffeine techniquesParticipants will be asked to refrain from drinking caffeinated beverages in the late afternoon and evening. | Behavioural | Project REST Platform+refrain from caffeine technique |
| Project REST PlatformParticipants will use the Project REST platform | Behavioural | Project REST Platform ONLY, Project REST Platform+refrain from caffeine technique |
Primary outcome
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.
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)
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.
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.
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.
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.
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".
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael A Grandner, PhD, MTR principal investigator
University of Arizona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Refrain from caffeine techniques and Project REST Platform in people with Poor Quality Sleep, run by University of Arizona at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 11 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Pittsburgh Sleep Quality Index (PSQI) (time frame: Change from baseline to post-intervention, around 6 weeks after baseline). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2025.