SleepNCT06201390
Stable Sleep Pattern Before Sleep Loss
A study testing Sleep consistency in people with Sleep, run by Texas Tech University at 1 site in United States.
Trial summary
Sleep is now recognized as important for disease prevention. Too little or too much sleep contributes to cardiovascular disease. Leading health organizations recommend adults sleep 7-9 hours per night for optimal health. Read more about this study
- Who is it for?
- Ages 35 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep
- What is being tested?
- Sleep consistency
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Jan 2024to 8 Feb 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 35 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women and men
- 35-64 years of age
Who cannot join
- obese based on BMI >29 kg/m2
- night-shift work
- prior diagnosis of sleep apnea
- signs of insomnia using the Insomnia Symptom Questionnaire
- a 'poor sleeper' (global score ≥5) based on the Pittsburgh Sleep Quality Index
- taking medications that alter sleep
Show all 9Show fewer
- personal history of stroke, coronary heart disease, diabetes mellitus
- taking antihypertensive medications
- smoker (including vaping)
Trial locations and contacts
1 site in 1 country.
United States1 site
Kinesiology and Sport Management building
Lubbock, Texas, 79409-3011
About this study
Official title: Effect of Stable Sleep Patterns on Peripheral Vascular Function Following Sleep Deprivation
Sleep is now recognized as important for disease prevention. Too little or too much sleep contributes to cardiovascular disease. Leading health organizations recommend adults sleep 7-9 hours per night for optimal health. This recommendation is based on research that finds reductions in sleep duration elevate blood pressure and impair vasodilation of blood vessels. One question raised in a recent NIH Workshop report (PMID:36448463) is whether stable sleep patterns, irrespective of a person's sleep duration, could mitigate the adverse effects of insufficient sleep on vascular function. This project will address this question in midlife adults using a randomized, crossover designed study.
Read the detailed description
Purpose and hypothesis The aim of this study will be to test the hypothesis that stable sleep, as defined by a consistent (low variability) bedtime and wake-time schedule, will diminish the negative effect of sleep deprivation on vascular function.
Study design and procedures Thirty adults (15 men, 15 women) will complete a 6-week study that will involve five study visits. The first visit will include informed consent, collection of demographic data, sleep- and health-related surveys, and familiarization with study procedures. Participants will then be block randomized to either habitual sleep followed by stable sleep, or stable sleep followed by habitual sleep - each sleep condition will lasts two weeks. In the habitual sleep condition, participants will be asked to follow their normal routine without concern about their sleep duration. In the stable sleep condition, participants will be asked to keep the same bedtime and wake-time schedule without deviation. Bedtime and wake-times will be determined by the researchers, but individualized for each participant so that their usual sleep duration (based on self-report) is met. Sleep will be monitored throughout the study using research-grade motion sensors worn at the wrist. Resting blood pressure, blood vessel vasodilatory function, and cardiovascular responses to exercise will be our main outcome variables. These variables will be measured before (on day #13) and after (on day #14) one night of sleep deprivation. Total sleep deprivation is a well-established experimental model to understand the acute effects of insufficient sleep on vascular function in humans.
- Conditions
- Sleep
- Being tested
- Sleep consistency
- Keywords
- sleep variability, blood pressure, sleep deprivation, vasodilation
- Medical subject headings
- Sleep Deprivation, Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep consistencyBehavioural
Participants will be asked to maintain a consistent bed- and wake-time.
| Study group | Role | What they receive |
|---|---|---|
| Stable sleep | Experimental | Participants will be asked to maintain a consistent sleep pattern for two weeks. Receives: Behavioral: Sleep consistency |
| Habitual Sleep | No intervention | Participants will be asked to maintain their usual sleep pattern for two weeks. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Peak Reactive Hyperemia
Peak forearm blood flow will be measured before and after one night of sleep deprivation that follows two weeks of normal sleep or stable sleep. Peak reactive hyperemia in the forearm (ml/100ml/min) will be measured using venous occlusion plethysmography after 10 minutes of forearm ischemia resulting from blood pressure cuff inflation at the upper-arm. Peak blood flow is considered the highest blood flow measurement after the blood pressure cuff is deflated.
Measured: pre-intervention; immediately after the intervention
Change in Arterial Stiffness
Arterial stiffness will be measured measured before and after one night of sleep deprivation that follows two weeks of normal sleep or stable sleep. Carotid-femoral pulse wave velocity will be used as the measure of arterial stiffness. Radial arterial tonometry will be used to derive a central aortic blood pressure wave. Wave separation analysis of the aortic pressure wave will then used to calculate pulse wave velocity from transit time and carotid-femoral path length.
Measured: pre-intervention; immediately after the intervention
Change in Blood Pressure Reactivity
Blood pressure responses to isometric handgrip exercise will be measured before and after one night of sleep deprivation that follows two weeks of normal sleep or stable sleep. Mean blood pressure reactivity will be measured using finger plethysmography during 2-minutes of isometric handgrip exercise followed by 3-minutes of post-exercise circulatory arrest.
Measured: pre-intervention; immediately after the intervention
Change in Cerebral oxygenation
Regional cerebral oxygenation during a cognitive task will be measured before and after one night of sleep deprivation that follows two weeks of normal sleep or stable sleep. Oxy- and deoxy-hemoglobin levels in the prefrontal cortex will be measured using a near infrared spectroscopy (NIRs) device.
Measured: pre-intervention; immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2024
- Study start25 Jan 2024
- Primary completion8 Feb 2025
- Study completion8 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SleepStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Participants will complete a 6-week study that will involve five study visits. The first visit will include informed consent, collection of demographic data, sleep- and health-related surveys, and familiarization with study procedures. Participants will then be block randomized to either habitual sleep followed by stable sleep, or stable sleep followed by habitual sleep - each sleep condition will lasts two weeks. In the habitual sleep condition, participants will be asked to follow their normal routine without concern about their sleep duration. In the stable sleep condition, participants will be asked to keep the same bedtime and wake-time schedule without deviation. Blood pressure, blood vessel vasodilatory function, and cardiovascular responses to exercise will be our main outcome variables. These variables will be measured before (on day #13) and after (on day #14) one night of sleep deprivation.
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Texas Tech University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joaquin U Gonzales, PhD, Texas Tech University
- Investigators
- Joaquin U Gonzales, PhD, Principal investigator, Texas Tech University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06201390
- Sponsor's protocol ID
- IRB2023-1166
- Status last verified
- Mar 2025
- First submitted
- 14 Dec 2023
- Last updated
- 25 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All data collected or generated from the project will be made available on ClinicalTrials.gov within 12 months from the primary completion date.
Publications
Gonzales JU, Narvaez G. Short-term reduction in sleep irregularity modulates cardiac autonomic function and central hemodynamic parameters at rest. Sleep Med. 2025 Sep;133:106643. doi: 10.1016/j.sleep.2025.106643. Epub 2025 Jun 17.
PubMed 40543253
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Stable Sleep Patterns on Peripheral Vascular Function Following Sleep Deprivation
- ClinicalTrials.gov ID
- NCT06201390
- Acronym / sponsor ID
- IRB2023-1166
- Conditions
- Sleep
- Keywords
- sleep variability, blood pressure, sleep deprivation, vasodilation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Texas Tech UniversityUniversity, hospital or other
- Study start
- 25 Jan 2024 (actual)
- Primary completion
- 8 Feb 2025 (actual)
- Study completion
- 8 Feb 2025 (actual)
- First posted
- 11 Jan 2024 (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.
Sleep is now recognized as important for disease prevention. Too little or too much sleep contributes to cardiovascular disease. Leading health organizations recommend adults sleep 7-9 hours per night for optimal health. This recommendation is based on research that finds reductions in sleep duration elevate blood pressure and impair vasodilation of blood vessels. One question raised in a recent NIH Workshop report (PMID:36448463) is whether stable sleep patterns, irrespective of a person's sleep duration, could mitigate the adverse effects of insufficient sleep on vascular function. This project will address this question in midlife adults using a randomized, crossover designed study.
Detailed description
Purpose and hypothesis The aim of this study will be to test the hypothesis that stable sleep, as defined by a consistent (low variability) bedtime and wake-time schedule, will diminish the negative effect of sleep deprivation on vascular function.
Study design and procedures Thirty adults (15 men, 15 women) will complete a 6-week study that will involve five study visits. The first visit will include informed consent, collection of demographic data, sleep- and health-related surveys, and familiarization with study procedures. Participants will then be block randomized to either habitual sleep followed by stable sleep, or stable sleep followed by habitual sleep - each sleep condition will lasts two weeks. In the habitual sleep condition, participants will be asked to follow their normal routine without concern about their sleep duration. In the stable sleep condition, participants will be asked to keep the same bedtime and wake-time schedule without deviation. Bedtime and wake-times will be determined by the researchers, but individualized for each participant so that their usual sleep duration (based on self-report) is met. Sleep will be monitored throughout the study using research-grade motion sensors worn at the wrist. Resting blood pressure, blood vessel vasodilatory function, and cardiovascular responses to exercise will be our main outcome variables. These variables will be measured before (on day #13) and after (on day #14) one night of sleep deprivation. Total sleep deprivation is a well-established experimental model to understand the acute effects of insufficient sleep on vascular function in humans.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will complete a 6-week study that will involve five study visits. The first visit will include informed consent, collection of demographic data, sleep- and health-related surveys, and familiarization with study procedures. Participants will then be block randomized to either habitual sleep followed by stable sleep, or stable sleep followed by habitual sleep - each sleep condition will lasts two weeks. In the habitual sleep condition, participants will be asked to follow their normal routine without concern about their sleep duration. In the stable sleep condition, participants will be asked to keep the same bedtime and wake-time schedule without deviation. Blood pressure, blood vessel vasodilatory function, and cardiovascular responses to exercise will be our main outcome variables. These variables will be measured before (on day #13) and after (on day #14) one night of sleep deprivation.
| Arm | Type | Receives |
|---|---|---|
| Stable sleep | Experimental | Behavioral: Sleep consistencyParticipants will be asked to maintain a consistent sleep pattern for two weeks. |
| Habitual Sleep | No intervention | –Participants will be asked to maintain their usual sleep pattern for two weeks. |
Who may qualify
- Ages
- 35 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Women and men
- 35-64 years of age
Key exclusion criteria (9 listed)
- obese based on BMI >29 kg/m2
- night-shift work
- prior diagnosis of sleep apnea
- signs of insomnia using the Insomnia Symptom Questionnaire
- a 'poor sleeper' (global score ≥5) based on the Pittsburgh Sleep Quality Index
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 |
|---|---|---|
| Sleep consistencyParticipants will be asked to maintain a consistent bed- and wake-time. | Behavioural | Stable sleep |
Primary outcome
Change in Peak Reactive Hyperemia
Time frame: pre-intervention; immediately after the intervention
Peak forearm blood flow will be measured before and after one night of sleep deprivation that follows two weeks of normal sleep or stable sleep. Peak reactive hyperemia in the forearm (ml/100ml/min) will be measured using venous occlusion plethysmography after 10 minutes of forearm ischemia resulting from blood pressure cuff inflation at the upper-arm. Peak blood flow is considered the highest blood flow measurement after the blood pressure cuff is deflated.
Change in Arterial Stiffness
Time frame: pre-intervention; immediately after the intervention
Arterial stiffness will be measured measured before and after one night of sleep deprivation that follows two weeks of normal sleep or stable sleep. Carotid-femoral pulse wave velocity will be used as the measure of arterial stiffness. Radial arterial tonometry will be used to derive a central aortic blood pressure wave. Wave separation analysis of the aortic pressure wave will then used to calculate pulse wave velocity from transit time and carotid-femoral path length.
Change in Blood Pressure Reactivity
Time frame: pre-intervention; immediately after the intervention
Blood pressure responses to isometric handgrip exercise will be measured before and after one night of sleep deprivation that follows two weeks of normal sleep or stable sleep. Mean blood pressure reactivity will be measured using finger plethysmography during 2-minutes of isometric handgrip exercise followed by 3-minutes of post-exercise circulatory arrest.
Change in Cerebral oxygenation
Time frame: pre-intervention; immediately after the intervention
Regional cerebral oxygenation during a cognitive task will be measured before and after one night of sleep deprivation that follows two weeks of normal sleep or stable sleep. Oxy- and deoxy-hemoglobin levels in the prefrontal cortex will be measured using a near infrared spectroscopy (NIRs) device.
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 25 Mar 2025.
- Derived from this study: PubMed 40543253Gonzales JU, Narvaez G. Short-term reduction in sleep irregularity modulates cardiac autonomic function and central hemodynamic parameters at rest. Sleep Med. 2025 Sep;133:106643. doi: 10.1016/j.sleep.2025.106643. Epub 2025 Jun 17.
- Individual participant dataSharing planned: Yes. All data collected or generated from the project will be made available on ClinicalTrials.gov within 12 months from the primary completion date.
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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.
Joaquin U Gonzales, PhD principal investigator
Texas Tech University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sleep consistency in people with Sleep, run by Texas Tech University 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 2 inclusion and 9 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 25 Mar 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. 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?
Change in Peak Reactive Hyperemia (time frame: pre-intervention; immediately after the intervention). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06201390, which also lists 1 linked publication.
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 25 Mar 2025.