Sex-specific Effect of Restricted Sleep on Brain Health
1 other identifier
interventional
16
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2023
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 16, 2023
CompletedFirst Posted
Study publicly available on registry
June 27, 2023
CompletedStudy Start
First participant enrolled
October 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2025
CompletedNovember 26, 2025
November 1, 2025
1.8 years
June 16, 2023
November 20, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Cerebral blood flow velocity
Greater morning cerebral blood flow velocity following a night of normal sleep compared to restricted sleep
Two days
Study Arms (2)
Normal sleep
PLACEBO COMPARATORParticipants will sleep for 7-9 hours the night prior to the study visit.
Restricted sleep
EXPERIMENTALParticipants will restrict sleep to four hours the night prior to the study visit.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Healthy adult men and women, 18-45 years of age, BMI 18-30 kg/m2, non-pregnant, non-breastfeeding, and non-nicotine users
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Missouri
Columbia, Missouri, 65211, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Interim Chair & Associate Professor
Study Record Dates
First Submitted
June 16, 2023
First Posted
June 27, 2023
Study Start
October 1, 2023
Primary Completion
July 1, 2025
Study Completion
September 1, 2025
Last Updated
November 26, 2025
Record last verified: 2025-11