- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05920759
Sex-specific Effect of Restricted Sleep on Brain Health
November 20, 2025 updated by: Jill Kanaley, University of Missouri-Columbia
The goal of this clinical trial is to compare the impact of restricted sleep on brain blood health in healthy men and women. The main question[s] it aims to answer are:
- Whether morning cerebral blood flow velocity is greater following a night of normal sleep compared to restricted sleep
- Whether the effect of sleep restriction on cerebral blood flow will be greater in males compared to females Participants will complete one 1-hour screening visit and two 2.5-hour study visits. Study visits will be conducted on two separate days.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Transcranial Doppler (TCD) is a non-invasive diagnostic tool used to estimate cerebral blood flow velocity (CBFV), cerebral autoregulation, cerebrovascular reactivity (CVR), intracranial pressure, cerebral perfusion pressure as well as other indicators of cerebral hemodynamics and autoregulation.
Whereas TCD has been widely used in research, clinical, and outpatient settings, studies specifically designed to examine the effect of limited sleep on brain health and potential impact of sex are sparse.
Thus, the present study will investigate sex-specific differences in cerebral blood flow under conditions of normal and restricted sleep.
Investigators will conduct measures of CBFV and CVR on two separate days under tightly controlled experimental conditions.
This study hypothesizes greater morning cerebral blood flow velocity following a night of normal sleep compared to restricted sleep.
This study further hypothesize the effect of sleep restriction on CBFV and CVR will be greater in males compared to females.
Results from the present study will provide important data necessary to develop future, well-controlled studies examining the impact of long-term modifications in exercise and/or sleep on cerebral hemodynamics and, by extension, risk for cerebrovascular events (i.e.
stroke).
Study Type
Interventional
Enrollment (Actual)
16
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
-
-
Missouri
-
Columbia, Missouri, United States, 65211
- University of Missouri
-
-
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
Yes
Description
Inclusion Criteria:
- Healthy adult men and women, 18-45 years of age, BMI 18-30 kg/m2, non-pregnant, non-breastfeeding, and non-nicotine users
Exclusion Criteria:
- any medications known to affect sleep, autonomic, metabolic, or cardiovascular health, have a self-reported history of hepatic, renal, pulmonary, cardiovascular, or neurological disease, stroke or neurovascular disease, bleeding/clotting disorders, sleep apnea or other sleep disorders, diabetes, history of alcoholism or substance abuse, major cardiovascular event or surgical procedure within the past three months, or hypertension
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: Other
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Placebo Comparator: Normal sleep
Participants will sleep for 7-9 hours the night prior to the study visit.
|
Transcranial Doppler (TCD) is a non-invasive diagnostic tool used to estimate cerebral blood flow velocity (CBFV), cerebral autoregulation, cerebrovascular reactivity (CVR), intracranial pressure, cerebral perfusion pressure as well as other indicators of cerebral hemodynamics and autoregulation.
|
|
Experimental: Restricted sleep
Participants will restrict sleep to four hours the night prior to the study visit.
|
Transcranial Doppler (TCD) is a non-invasive diagnostic tool used to estimate cerebral blood flow velocity (CBFV), cerebral autoregulation, cerebrovascular reactivity (CVR), intracranial pressure, cerebral perfusion pressure as well as other indicators of cerebral hemodynamics and autoregulation.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cerebral blood flow velocity
Time Frame: Two days
|
Greater morning cerebral blood flow velocity following a night of normal sleep compared to restricted sleep
|
Two days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
October 1, 2023
Primary Completion (Actual)
July 1, 2025
Study Completion (Actual)
September 1, 2025
Study Registration Dates
First Submitted
June 16, 2023
First Submitted That Met QC Criteria
June 16, 2023
First Posted (Actual)
June 27, 2023
Study Record Updates
Last Update Posted (Actual)
November 26, 2025
Last Update Submitted That Met QC Criteria
November 20, 2025
Last Verified
November 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2097207
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
Yes
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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