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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05920759
Other study ID # 2097207
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date October 1, 2023
Est. completion date September 1, 2024

Study information

Verified date May 2024
Source University of Missouri-Columbia
Contact Jill Kanaley, PhD
Phone 573-882-2519
Email kanaleyj@missouri.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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).


Recruitment information / eligibility

Status Recruiting
Enrollment 20
Est. completion date September 1, 2024
Est. primary completion date July 1, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 45 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Cerebral blood flow
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.

Locations

Country Name City State
United States University of Missouri Columbia Missouri

Sponsors (1)

Lead Sponsor Collaborator
University of Missouri-Columbia

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Cerebral blood flow velocity Greater morning cerebral blood flow velocity following a night of normal sleep compared to restricted sleep Two days
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