Sleep DeprivationNCT01433315
Physiologic Effects of Sleep Restriction
A study testing sleep restriction in people with Sleep Deprivation, run by Mayo Clinic at 1 site in United States.
Trial summary
Evidence suggests a relationship between sleep deprivation and cardiovascular disease. The investigators wish to determine whether 9 nights of modest sleep restriction results in activation of cardiovascular disease mechanisms, thus potentially increasing the risk of cardiovascular disease. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep Deprivation
- What is being tested?
- sleep restriction
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2011to 27 Apr 2017
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 18-40 years
- No chronic medical conditions other than seasonal or environmental allergies
- On no prescription medications other than second generation antihistamines (Cetirizine, Fexofenadine, Desloratadine, Loratadine, etc), oral contraceptive pills, or intrauterine devices.
- BMI 18.5-35 kg/m2
- Both normotensive and prehypertensive people are eligible and will be studied
- Not a current smoker or tobacco user
- Not pregnant or breast feeding and not intending to become pregnant or breast feed
Who cannot join
- The investigators will exclude subjects who have any medical or psychiatric disorders
- History of anxiety or depression, and those taking any medications other than non-sedating antihistamines or oral contraceptives.
- Those found to have depression on a depression screening tool (BDI-II) will be excluded. Current smokers will be excluded.
- All female subjects will undergoing a screening pregnancy test and excluded if positive.
- Subjects found to have significant sleep disorders will be excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Evidence suggests a relationship between sleep deprivation and cardiovascular disease. The investigators wish to determine whether 9 nights of modest sleep restriction results in activation of cardiovascular disease mechanisms, thus potentially increasing the risk of cardiovascular disease. The investigators hypothesize that sleep restriction will result in elevated blood pressure, inflammation, and neurocognitive deficits.
Read the detailed description
Evidence suggests a relationship between sleep deprivation and cardiovascular disease. Voluntary sleep restriction is common, with 28% of the US adult population reports getting 6 or fewer hours of sleep per night, and those who do are 24% more likely to have cardiovascular disease and have twice the risk of hypertension. Insufficient sleep may conceivably be one of the most common, and most preventable, cardiovascular risk factors. The investigators wish to determine whether 9 nights of modest sleep restriction results in activation of cardiovascular disease mechanisms, thus potentially increasing the risk of cardiovascular disease. The investigators will combine our cardiovascular studies with state-of-the art sleep monitoring and neurocognitive tests to provide unambiguous data on the physiologic effects of sleep restriction. Together, the investigators findings will help explain whether the reduced sleep duration in the general population may be contributing to the current epidemic of cardiovascular disease, and suggest strategies to reduce this risk.
- Conditions
- Sleep Deprivation
- Being tested
- sleep restriction
- Keywords
- sleep deprivation, sleep restriction
- Medical subject headings
- Sleep Deprivation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sleep restrictionBehavioural
restricted sleep
| Study group | Role | What they receive |
|---|---|---|
| sleep restriction | Experimental | restricted sleep during the experimental period Receives: Behavioral: sleep restriction |
| normal sleep | No intervention | normal sleep during the experimental period |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in blood pressure
Change in mean arterial blood pressure over 24 hours, measured during acclimation, experimental, and recovery timepoints over the study period.
Measured: throughout 16 days
Secondary outcomes (7)
Change in catecholamines
Change in catecholamines, measured during acclimation, experimental, and recovery
Measured: throughout 16 days
Change in endothelial function
Change in endothelial function, measured during acclimation, experimental, and recovery timepoints.
Measured: throughout 16 days
Change in baroreflex sensitivity
Change in baroreflex sensitivity, measured during acclimation, experimental, and recovery
Measured: throughout 16 days
Change in arterial stiffness
Change in arterial stiffness, measured during acclimation, experimental, and recovery timepoints.
Measured: throughout 16 days
Change in electrocardiographic characteristics
Change in electrocardiographic characteristics, measured during acclimation, experimental, and recovery timepoints.
Measured: throughout 16 days
Change in markers of inflammation
Change in markers of inflammation, measured during acclimation, experimental, and recovery timepoints.
Measured: throughout 16 days
Change in fat tissue characteristics
Change in fat tissue characteristics, determined by analysis of a fat biopsy sample.
Measured: throughout 16 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2011 (estimated)
- Study startOct 2011
- Primary completion27 Apr 2017
- Study completion27 Apr 2017
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 Sleep DeprivationStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Virend Somers, MD, PhD, Mayo Clinic
- Investigators
- Virend K Somers, MD, PhD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01433315
- Sponsor's protocol ID
- 11-002121
- Status last verified
- Jan 2022
- First submitted
- 15 Aug 2011
- Last updated
- 20 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
Greenlund IM, Covassin N, Bukartyk J, St Louis EK, Calvin AD, Somers VK. Heart rate and vascular responses to spontaneous arousals following experimental sleep restriction. Am J Physiol Heart Circ Physiol. 2026 Jun 1;330(6):H2058-H2067. doi: 10.1152/ajpheart.00123.2026. Epub 2026 May 14.
PubMed 42133047
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physiologic Effects of Sleep Restriction
- ClinicalTrials.gov ID
- NCT01433315
- Acronym / sponsor ID
- 11-002121
- Conditions
- Sleep Deprivation
- Keywords
- sleep deprivation, sleep restriction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- 27 Apr 2017 (actual)
- Study completion
- 27 Apr 2017 (actual)
- First posted
- 13 Sep 2011 (estimated)
- 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.
Evidence suggests a relationship between sleep deprivation and cardiovascular disease. The investigators wish to determine whether 9 nights of modest sleep restriction results in activation of cardiovascular disease mechanisms, thus potentially increasing the risk of cardiovascular disease. The investigators hypothesize that sleep restriction will result in elevated blood pressure, inflammation, and neurocognitive deficits.
Detailed description
Evidence suggests a relationship between sleep deprivation and cardiovascular disease. Voluntary sleep restriction is common, with 28% of the US adult population reports getting 6 or fewer hours of sleep per night, and those who do are 24% more likely to have cardiovascular disease and have twice the risk of hypertension. Insufficient sleep may conceivably be one of the most common, and most preventable, cardiovascular risk factors. The investigators wish to determine whether 9 nights of modest sleep restriction results in activation of cardiovascular disease mechanisms, thus potentially increasing the risk of cardiovascular disease. The investigators will combine our cardiovascular studies with state-of-the art sleep monitoring and neurocognitive tests to provide unambiguous data on the physiologic effects of sleep restriction. Together, the investigators findings will help explain whether the reduced sleep duration in the general population may be contributing to the current epidemic of cardiovascular disease, and suggest strategies to reduce this risk.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| sleep restriction | Experimental | Behavioral: sleep restrictionrestricted sleep during the experimental period |
| normal sleep | No intervention | –normal sleep during the experimental period |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Age 18-40 years
- No chronic medical conditions other than seasonal or environmental allergies
- On no prescription medications other than second generation antihistamines (Cetirizine, Fexofenadine, Desloratadine, Loratadine, etc), oral contraceptive pills, or intrauterine devices.
- BMI 18.5-35 kg/m2
- Both normotensive and prehypertensive people are eligible and will be studied
Key exclusion criteria (5 listed)
- The investigators will exclude subjects who have any medical or psychiatric disorders
- History of anxiety or depression, and those taking any medications other than non-sedating antihistamines or oral contraceptives.
- Those found to have depression on a depression screening tool (BDI-II) will be excluded. Current smokers will be excluded.
- All female subjects will undergoing a screening pregnancy test and excluded if positive.
- Subjects found to have significant sleep disorders will be excluded.
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 restrictionrestricted sleep | Behavioural | sleep restriction |
Primary outcome
Change in blood pressure
Time frame: throughout 16 days
Change in mean arterial blood pressure over 24 hours, measured during acclimation, experimental, and recovery timepoints over the study period.
7 secondary outcomes
Change in catecholamines
Time frame: throughout 16 days
Change in endothelial function
Time frame: throughout 16 days
Change in baroreflex sensitivity
Time frame: throughout 16 days
Change in arterial stiffness
Time frame: throughout 16 days
Change in electrocardiographic characteristics
Time frame: throughout 16 days
Change in markers of inflammation
Time frame: throughout 16 days
Change in fat tissue characteristics
Time frame: throughout 16 days
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 20 Jan 2022.
- Derived from this study: PubMed 42133047Greenlund IM, Covassin N, Bukartyk J, St Louis EK, Calvin AD, Somers VK. Heart rate and vascular responses to spontaneous arousals following experimental sleep restriction. Am J Physiol Heart Circ Physiol. 2026 Jun 1;330(6):H2058-H2067. doi: 10.1152/ajpheart.00123.2026. Epub 2026 May 14.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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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.
Virend K Somers, MD, PhD principal investigator
Mayo Clinic
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 restriction in people with Sleep Deprivation, run by Mayo Clinic 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 7 inclusion and 5 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 20 Jan 2022. 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 blood pressure (time frame: throughout 16 days). 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 NCT01433315, 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 20 Jan 2022.