NCT05920759

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 16, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 27, 2023

Completed
3 months until next milestone

Study Start

First participant enrolled

October 1, 2023

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2025

Completed
Last Updated

November 26, 2025

Status Verified

November 1, 2025

Enrollment Period

1.8 years

First QC Date

June 16, 2023

Last Update Submit

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 COMPARATOR

Participants will sleep for 7-9 hours the night prior to the study visit.

Diagnostic Test: Cerebral blood flow

Restricted sleep

EXPERIMENTAL

Participants will restrict sleep to four hours the night prior to the study visit.

Diagnostic Test: Cerebral blood flow

Interventions

Cerebral blood flowDIAGNOSTIC_TEST

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.

Normal sleepRestricted sleep

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

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

Location

MeSH Terms

Interventions

Cerebrovascular Circulation

Intervention Hierarchy (Ancestors)

Blood CirculationCardiovascular Physiological PhenomenaCirculatory and Respiratory Physiological Phenomena

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

Locations