- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07212101
- Original Trial
Sleep in Collegiate Baseball Players
December 11, 2025 updated by: Marie-Pierre St-Onge, Columbia University
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
38
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New York
-
New York, New York, United States, 10032
- Columbia University Irving Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Collegiate baseball player at Columbia University
Exclusion Criteria:
- None
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Sleep & diet intervention
Participants will be asked to increase their fruit and vegetable consumption, time in bed, and modify light exposure across the day
|
Participants will be asked to increase their fruit and vegetable consumption, time in bed, and modify light exposure across the day
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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)
|
pre and post intervention (4-6 weeks)
|
|
Sleep quality
Time Frame: Nightly for 6 weeks
|
Duration (h:min)
|
Nightly for 6 weeks
|
|
Sleep quality
Time Frame: Nightly for 6 weeks
|
Sleep stage (%REM, %Deep sleep)
|
Nightly for 6 weeks
|
|
Dietary quality
Time Frame: pre and post intervention (4-6 weeks)
|
3-day food recalls (ASA-24)
|
pre and post intervention (4-6 weeks)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Generalized Anxiety Disorder (GAD-7)
Time Frame: pre and post intervention (4-6 weeks)
|
7 questions, 0-3 points each (not at all to nearly every day); global score 0-21, higher score is worse
|
pre and post intervention (4-6 weeks)
|
|
Patient Health Questionnaire-9
Time Frame: pre and post intervention (4-6 weeks)
|
9 questions, 0-3 points each (not at all to nearly every day); global score 0-27, higher score is worse
|
pre and post intervention (4-6 weeks)
|
|
Sport Anxiety Scale-2
Time Frame: pre and post intervention (4-6 weeks)
|
4-point Likert scale (not at all to very much); global score 5-20, higher score is worse
|
pre and post intervention (4-6 weeks)
|
|
Pitching accuracy
Time Frame: pre and post intervention (4-6 weeks)
|
Ratio of strikes to balls (pitchers only)
|
pre and post intervention (4-6 weeks)
|
|
Isometric wall push
Time Frame: pre and post intervention (4-6 weeks)
|
Hand-held dynamometer (pounds) (pitchers only)
|
pre and post intervention (4-6 weeks)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Marie-Pierre St-Onge, Columbia University Vagelos College of Physicians & Surgeons
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 16, 2025
Primary Completion (Actual)
October 31, 2025
Study Completion (Actual)
October 31, 2025
Study Registration Dates
First Submitted
September 23, 2025
First Submitted That Met QC Criteria
September 30, 2025
First Posted (Estimated)
October 8, 2025
Study Record Updates
Last Update Posted (Actual)
December 18, 2025
Last Update Submitted That Met QC Criteria
December 11, 2025
Last Verified
December 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AAAV4501
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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