Sleep DeprivationNCT04535219
Effect of Total Sleep Deprivation on Vascular Function
A study testing Exercise and Supervised Total Sleep Deprivation in people with Sleep Deprivation, run by University of Florida at 1 site in United States.
Trial summary
Insufficient sleep is associated with an increased risk for cardiovascular disease. The causal mechanisms are currently unknown, but may include endothelial dysfunction. The purpose of this study is to examine the influence of sex and aging on the effects of total sleep deprivation on vascular function and whether… Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep Deprivation
- What is being tested?
- Exercise and Supervised Total Sleep Deprivation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Jul 2021to 2 Aug 2022
- 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 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Males and females
- 20 to 30 and 50 to 60 years of age
- Females will be eumenorrheic at enrollment or postmenopausal for at least 1 year
- No major clinical disease (e.g., diabetes, cardiovascular, liver or chronic kidney disease) to minimize confounding of vascular measures
- Participants will be sedentary (≤3x per week of ≤30 minutes of aerobic exercise/session) or trained (≥5x per week of moderate/vigorous aerobic exercise training)
Who cannot join
- Age <20 or 31 to 49 or >60 years
- Body mass index ≥30 kg/m^2 because obesity may affect vascular function
- Use of medication that may affect vascular measures
- Hormone replacement therapy or hormonal contraceptives within past year
- Use of tobacco products (chewing tobacco, traditional or e-cigarettes) because they may influence vascular function
- Being perimenopausal, pregnant or lactating because may influence vascular function
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- Being a shift worker because habitual sleep deprivation and altered circadian rhythm may influence vascular function.
- Not having an "intermediate" chronotype based on the Morningness-Eveningness Questionnaire (MEQ; score <31 or >69) because this would influence the effect of overnight sleep deprivation on vascular function.
- Sleep complaints based on the Pittsburgh Sleep Quality Index (PSQI; score >5) because this would influence the effect of overnight sleep deprivation on vascular function.
Trial locations and contacts
1 site in 1 country.
About this study
Insufficient sleep is associated with an increased risk for cardiovascular disease. The causal mechanisms are currently unknown, but may include endothelial dysfunction. The purpose of this study is to examine the influence of sex and aging on the effects of total sleep deprivation on vascular function and whether exercise training attenuates these effects.
- Conditions
- Sleep Deprivation
- Being tested
- Exercise, Supervised Total Sleep Deprivation
- Medical subject headings
- Sleep Deprivation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
60 minutes of moderate-intensity treadmill exercise (70% of maximal heart rate determined from the maximal graded exercise test)
Supervised Total Sleep DeprivationOther
Laboratory-monitored total sleep deprivation
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Participants will have vascular function assessed following total sleep deprivation Receives: Other: Supervised Total Sleep Deprivation |
| Group B | No intervention | Participants will have vascular function assessed following a full night of sleep |
| Group C | Experimental | Participants will have vascular function assessed following total sleep deprivation preceded by exercise Receives: Other: Exercise; Other: Supervised Total Sleep Deprivation |
| Group D | No intervention | Participants will have vascular function assessed following a full night of sleep |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endothelial function
Endothelial function will be determined using brachial artery flow-mediated dilation via high resolution duplex ultrasonography. Reactive hyperemia will be produced by inflating a forearm cuff to ~250 mmHg for 5 minutes followed by rapid deflation.
Measured: through study completion, an average of 1 month
Microvascular function
Microvascular function will be assessed using the forearm blood flow response to submaximal handgrip exercise. Brachial artery blood flow and diameter will be assessed using Doppler ultrasound.
Measured: through study completion, an average of 1 month
Secondary outcomes (2)
Central arterial stiffness
The SphygmoCor XCEL device will be used to measure carotid to femoral pulse wave velocity.
Measured: through study completion, an average of 1 month
Central arterial hemodynamics
The SphygmoCor XCEL device will be used to obtain central pulse wave analysis.
Measured: through study completion, an average of 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2020
- Study start11 Jul 2021
- Primary completion2 Aug 2022
- Study completion2 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep DeprivationStudies of the same condition, open and under way.
- More trials run by University of FloridaThe 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Demetra Christou, PhD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04535219
- Sponsor's protocol ID
- IRB201901937
- Status last verified
- Aug 2023
- First submitted
- 24 Aug 2020
- Last updated
- 29 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Total Sleep Deprivation on Vascular Function
- ClinicalTrials.gov ID
- NCT04535219
- Acronym / sponsor ID
- IRB201901937
- Conditions
- Sleep Deprivation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- 11 Jul 2021 (actual)
- Primary completion
- 2 Aug 2022 (actual)
- Study completion
- 2 Aug 2022 (actual)
- First posted
- 1 Sep 2020 (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.
Insufficient sleep is associated with an increased risk for cardiovascular disease. The causal mechanisms are currently unknown, but may include endothelial dysfunction. The purpose of this study is to examine the influence of sex and aging on the effects of total sleep deprivation on vascular function and whether exercise training attenuates these effects.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Other: Supervised Total Sleep DeprivationParticipants will have vascular function assessed following total sleep deprivation |
| Group B | No intervention | –Participants will have vascular function assessed following a full night of sleep |
| Group C | Experimental | Other: Exercise, Other: Supervised Total Sleep DeprivationParticipants will have vascular function assessed following total sleep deprivation preceded by exercise |
| Group D | No intervention | –Participants will have vascular function assessed following a full night of sleep |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Males and females
- 20 to 30 and 50 to 60 years of age
- Females will be eumenorrheic at enrollment or postmenopausal for at least 1 year
- No major clinical disease (e.g., diabetes, cardiovascular, liver or chronic kidney disease) to minimize confounding of vascular measures
- Participants will be sedentary (≤3x per week of ≤30 minutes of aerobic exercise/session) or trained (≥5x per week of moderate/vigorous aerobic exercise training)
Key exclusion criteria (9 listed)
- Age <20 or 31 to 49 or >60 years
- Body mass index ≥30 kg/m^2 because obesity may affect vascular function
- Use of medication that may affect vascular measures
- Hormone replacement therapy or hormonal contraceptives within past year
- Use of tobacco products (chewing tobacco, traditional or e-cigarettes) because they may influence vascular function
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 |
|---|---|---|
| Exercise60 minutes of moderate-intensity treadmill exercise (70% of maximal heart rate determined from the maximal graded exercise test) | Other | Group C |
| Supervised Total Sleep DeprivationLaboratory-monitored total sleep deprivation | Other | Group A, Group C |
Primary outcome
Endothelial function
Time frame: through study completion, an average of 1 month
Endothelial function will be determined using brachial artery flow-mediated dilation via high resolution duplex ultrasonography. Reactive hyperemia will be produced by inflating a forearm cuff to ~250 mmHg for 5 minutes followed by rapid deflation.
Microvascular function
Time frame: through study completion, an average of 1 month
Microvascular function will be assessed using the forearm blood flow response to submaximal handgrip exercise. Brachial artery blood flow and diameter will be assessed using Doppler ultrasound.
2 secondary outcomes
Central arterial stiffness
Time frame: through study completion, an average of 1 month
Central arterial hemodynamics
Time frame: through study completion, an average of 1 month
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 29 Aug 2023.
- Individual participant dataSharing planned: No
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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.
Demetra Christou, PhD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise and Supervised Total Sleep Deprivation in people with Sleep Deprivation, run by University of Florida 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 5 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 29 Aug 2023. 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?
Endothelial function (time frame: through study completion, an average of 1 month). The study lists 2 primary outcomes in all. 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 29 Aug 2023.