Cerebrovascular CirculationNCT05920759
Sex-specific Effect of Restricted Sleep on Brain Health
A study testing Cerebral blood flow in people with Cerebrovascular Circulation, run by University of Missouri-Columbia at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Cerebrovascular Circulation
- What is being tested?
- Cerebral blood flow
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2023to 1 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adult men and women, 18-45 years of age, BMI 18-30 kg/m2, non-pregnant, non-breastfeeding, and non-nicotine users
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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).
- Conditions
- Cerebrovascular Circulation
- Being tested
- Cerebral blood flow
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Normal sleep | Placebo comparator | Participants will sleep for 7-9 hours the night prior to the study visit. Receives: Diagnostic Test: Cerebral blood flow |
| Restricted sleep | Experimental | Participants will restrict sleep to four hours the night prior to the study visit. Receives: Diagnostic Test: Cerebral blood flow |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cerebral blood flow velocity
Greater morning cerebral blood flow velocity following a night of normal sleep compared to restricted sleep
Measured: Two days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2023
- Study start1 Oct 2023
- Primary completion1 Jul 2025
- Study completion1 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebrovascular CirculationStudies of the same condition, open and under way.
- More trials run by University of Missouri-ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Missouri-Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jill Kanaley, University of Missouri-Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05920759
- Sponsor's protocol ID
- 2097207
- Status last verified
- Nov 2025
- First submitted
- 16 Jun 2023
- Last updated
- 26 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sex-specific Effect of Restricted Sleep on Brain Health
- ClinicalTrials.gov ID
- NCT05920759
- Acronym / sponsor ID
- 2097207
- Conditions
- Cerebrovascular Circulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University of Missouri-ColumbiaUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 1 Jul 2025 (actual)
- Study completion
- 1 Sep 2025 (actual)
- First posted
- 27 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normal sleep | Placebo comparator | Diagnostic Test: Cerebral blood flowParticipants will sleep for 7-9 hours the night prior to the study visit. |
| Restricted sleep | Experimental | Diagnostic Test: Cerebral blood flowParticipants will restrict sleep to four hours the night prior to the study visit. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy adult men and women, 18-45 years of age, BMI 18-30 kg/m2, non-pregnant, non-breastfeeding, and non-nicotine users
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cerebral blood flowTranscranial 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. | Diagnostic test | Normal sleep, Restricted sleep |
Primary outcome
Cerebral blood flow velocity
Time frame: Two days
Greater morning cerebral blood flow velocity following a night of normal sleep compared to restricted sleep
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cerebral blood flow in people with Cerebrovascular Circulation, run by University of Missouri-Columbia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cerebral blood flow velocity (time frame: Two days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2025.