SleepNCT07212101
Sleep in Collegiate Baseball Players
A study testing Sleep and diet in people with Sleep, run by Columbia University at 1 site in United States.
Trial summary
Sleep is an essential biological function that impacts nearly every aspect of an athlete's physical and mental health. For athletes, the importance of high-quality sleep cannot be overstated, as it plays a critical role in performance, recovery, and overall well-being. Read more about this study
- Who is it for?
- Ages 18 to 25 years
- Conditions the study is for
- Sleep
- What is being tested?
- Sleep and diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Sep 2025to 31 Oct 2025
- 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 to 25 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Collegiate baseball player at Columbia University
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbia University Irving Medical Center
New York, New York, 10032
About this study
Official title: Assessing and Optimizing Sleep, Diet, and Performance in Columbia University Baseball Players
Sleep is an essential biological function that impacts nearly every aspect of an athlete's physical and mental health. For athletes, the importance of high-quality sleep cannot be overstated, as it plays a critical role in performance, recovery, and overall well-being. Sleep supports muscle recovery by promoting protein synthesis and the release of growth hormones, essential for healing after intense physical exertion. Furthermore, adequate sleep is crucial for maintaining cognitive sharpness, decision-making abilities, and emotional regulation-all of which are necessary for optimal athletic performance. The study will assess both sleep quality and quantity in baseball players at Columbia University. These tools will help quantify key sleep metrics, including sleep duration, latency (the time it takes to fall asleep), and the number of awakenings during the night. Similarly, the study will analyze dietary patterns using the Automated Self-Administered 24-Hour Dietary Assessment (ASA24), tracking nutrient intake, meal timing, and the consumption of ultra-processed foods. These assessments will establish a baseline from which to measure improvement post-intervention. The intervention will focus on improving diet, time in bed, and light exposure to improve sleep, diet, and performance in collegiate baseball athletes.
- Conditions
- Sleep
- Being tested
- Sleep and diet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep and dietBehavioural
Participants will be asked to increase their fruit and vegetable consumption, time in bed, and modify light exposure across the day
| Study group | Role | What they receive |
|---|---|---|
| Sleep & diet intervention | Experimental | Participants will be asked to increase their fruit and vegetable consumption, time in bed, and modify light exposure across the day Receives: Behavioral: Sleep and diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Athletic performance (position-specific for batters and pitchers)
Batters: Baseball radar gun, outcome is exit velocity (speed at which ball leaves the bat, in miles/h) Pitchers: Baseball radar gun measuring velocity (miles/h)
Measured: pre and post intervention (4-6 weeks)
Sleep quality
Duration (h:min)
Measured: Nightly for 6 weeks
Sleep quality
Sleep stage (%REM, %Deep sleep)
Measured: Nightly for 6 weeks
Dietary quality
3-day food recalls (ASA-24)
Measured: pre and post intervention (4-6 weeks)
Secondary outcomes (5)
Generalized Anxiety Disorder (GAD-7)
7 questions, 0-3 points each (not at all to nearly every day); global score 0-21, higher score is worse
Measured: pre and post intervention (4-6 weeks)
Patient Health Questionnaire-9
9 questions, 0-3 points each (not at all to nearly every day); global score 0-27, higher score is worse
Measured: pre and post intervention (4-6 weeks)
Sport Anxiety Scale-2
4-point Likert scale (not at all to very much); global score 5-20, higher score is worse
Measured: pre and post intervention (4-6 weeks)
Pitching accuracy
Ratio of strikes to balls (pitchers only)
Measured: pre and post intervention (4-6 weeks)
Isometric wall push
Hand-held dynamometer (pounds) (pitchers only)
Measured: pre and post intervention (4-6 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2025
- Study start16 Sep 2025
- Primary completion31 Oct 2025
- Study completion31 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SleepStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single group intervention evaluating outcomes pre and post intervention
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Arizona, Idorsia Pharmaceuticals Ltd., Oura Ring
- Responsible party
- Principal investigator, Marie-Pierre St-Onge, Columbia University
- Investigators
- Marie-Pierre St-Onge, Principal investigator, Columbia University Vagelos College of Physicians & Surgeons
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07212101
- Sponsor's protocol ID
- AAAV4501
- Status last verified
- Dec 2025
- First submitted
- 23 Sep 2025
- Last updated
- 18 Dec 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 18 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing and Optimizing Sleep, Diet, and Performance in Columbia University Baseball Players
- ClinicalTrials.gov ID
- NCT07212101
- Acronym / sponsor ID
- AAAV4501
- Conditions
- Sleep
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- University of Arizona, Idorsia Pharmaceuticals Ltd., Oura Ring
- Study start
- 16 Sep 2025 (actual)
- Primary completion
- 31 Oct 2025 (actual)
- Study completion
- 31 Oct 2025 (actual)
- First posted
- 8 Oct 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.
Sleep is an essential biological function that impacts nearly every aspect of an athlete's physical and mental health. For athletes, the importance of high-quality sleep cannot be overstated, as it plays a critical role in performance, recovery, and overall well-being. Sleep supports muscle recovery by promoting protein synthesis and the release of growth hormones, essential for healing after intense physical exertion. Furthermore, adequate sleep is crucial for maintaining cognitive sharpness, decision-making abilities, and emotional regulation-all of which are necessary for optimal athletic performance. The study will assess both sleep quality and quantity in baseball players at Columbia University. These tools will help quantify key sleep metrics, including sleep duration, latency (the time it takes to fall asleep), and the number of awakenings during the night. Similarly, the study will analyze dietary patterns using the Automated Self-Administered 24-Hour Dietary Assessment (ASA24), tracking nutrient intake, meal timing, and the consumption of ultra-processed foods. These assessments will establish a baseline from which to measure improvement post-intervention. The intervention will focus on improving diet, time in bed, and light exposure to improve sleep, diet, and performance in collegiate baseball athletes.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single group intervention evaluating outcomes pre and post intervention
| Arm | Type | Receives |
|---|---|---|
| Sleep & diet intervention | Experimental | Behavioral: Sleep and dietParticipants will be asked to increase their fruit and vegetable consumption, time in bed, and modify light exposure across the day |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Collegiate baseball player at Columbia University
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Sleep and dietParticipants will be asked to increase their fruit and vegetable consumption, time in bed, and modify light exposure across the day | Behavioural | Sleep & diet intervention |
Primary outcome
Athletic performance (position-specific for batters and pitchers)
Time frame: pre and post intervention (4-6 weeks)
Batters: Baseball radar gun, outcome is exit velocity (speed at which ball leaves the bat, in miles/h) Pitchers: Baseball radar gun measuring velocity (miles/h)
Sleep quality
Time frame: Nightly for 6 weeks
Duration (h:min)
Sleep quality
Time frame: Nightly for 6 weeks
Sleep stage (%REM, %Deep sleep)
Dietary quality
Time frame: pre and post intervention (4-6 weeks)
3-day food recalls (ASA-24)
5 secondary outcomes
Generalized Anxiety Disorder (GAD-7)
Time frame: pre and post intervention (4-6 weeks)
Patient Health Questionnaire-9
Time frame: pre and post intervention (4-6 weeks)
Sport Anxiety Scale-2
Time frame: pre and post intervention (4-6 weeks)
Pitching accuracy
Time frame: pre and post intervention (4-6 weeks)
Isometric wall push
Time frame: pre and post intervention (4-6 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2025.
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Healthy Adult Participants
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.
Marie-Pierre St-Onge principal investigator
Columbia University Vagelos College of Physicians & Surgeons
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sleep and diet in people with Sleep, run by Columbia University 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 18 Dec 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Athletic performance (position-specific for batters and pitchers) (time frame: pre and post intervention (4-6 weeks)). The study lists 4 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 18 Dec 2025.