HypertensionNCT06482814
Sleep Restriction and Parental History of Hypertension
A study testing Partial sleep deprivation (sleep restriction) and Normal sleep in people with Hypertension, run by Mayo Clinic at 1 site in United States.
Trial summary
The purpose of this study is to research the effects of partial sleep deprivation (sleep restriction) in a group of individuals whose parents have high blood pressure compared to a group of individuals whose parents have normal blood pressure. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypertension
- What is being tested?
- Partial sleep deprivation (sleep restriction) and Normal sleep
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Feb 2025to Apr 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adults aged 18-35 years
- Absence of any significant medical or psychiatric disease (as per the investigators' judgment)
- Nonsmoker
- Nonpregnant
- History of normal sleep duration (reported average sleep duration between 7-9 hours/night and no habitual napping)
- Hypertension status information available for both biological parents
- Ability to understand study procedures and to comply with them for the entire length of the study
- Ability to understand English and provide informed consent
Who cannot join
- Age <18 or >35 years
- Body mass index <18.5 or ≥30 kg/m2
- Pregnant or lactating
- Unable to determine history of HTN in participant's biological parents or subject being adopted
- Use of tobacco, vaping, marijuana products or other drugs
- Excessive caffeine consumption (>400 mg/day)
Show all 24Show fewer
- Excessive alcohol consumption (>7 drinks/week for women, >14 drinks/week for men)
- Office SBP/DBP ≥130/80 mmHg
- Daytime ambulatory SBP/DBP ≥130/80 mmHg
- Fasting glucose ≥126 mg/dl
- Glomerular filtration rate <60 mL/min/BSA
- History of significant medical or psychiatric disorders (as per the investigators' judgment)
- Regular use of prescription medications other than contraceptives
- Use of melatonin supplements or any other over-the-counter sleep aid
- Moderate-to-severe sleep disordered breathing (apnea/hypopnea index, AHI ≥15) or mild sleep disordered breathing (AHI 5-15) with daytime sleepiness (Epworth Sleepiness Scale >10)
- Moderate-to-severe insomnia (Insomnia Severity Index >14)
- Restless leg syndrome (as per the Cambridge-Hopkins questionnaire)
- Excessive daytime sleepiness (Epworth Sleepiness Scale >15)
- Extreme chronotype (Morningness-Eveningness Questionnaire >69 or <31)
- Night shift work
- Ongoing participation in other research studies (as per the investigators' judgment)
- Any other medical, geographic, or social factor making study participation impractical
- Not English-speaking and/or inability to provide informed consent
- Exclusionary for blood draws: hemoglobin <11.6 g/dL in women / <13.2 g/dL in men; participants with measured hemoglobin levels below these thresholds will be allowed to continue participate in study tests and procedures not involving blood draws.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
Naima Covassin
About this study
The purpose of this study is to research the effects of partial sleep deprivation (sleep restriction) in a group of individuals whose parents have high blood pressure compared to a group of individuals whose parents have normal blood pressure.
- Conditions
- Hypertension
- Being tested
- Partial sleep deprivation (sleep restriction), Normal sleep
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Partial sleep deprivation (sleep restriction)Behavioural
During the experimental segment the sleep opportunity will be restricted to 5 hours/night. During the acclimation and recovery phases a 9-hour/night sleep opportunity will be provided.
Normal sleepBehavioural
During the normal sleep condition a 9-hour/night sleep opportunity will be provided throughout the 10-day inpatient visit.
| Study group | Role | What they receive |
|---|---|---|
| Study Sequence AB | Experimental | Sleep restriction condition in the first period and normal sleep condition in the second period. Each period will consist of a 10-day inpatient visit comprising a 3-day/2-night baseline, followed by a 5-day/5-night experimental phase, and a 2-day/2-night recovery phase. Receives: Behavioral: Partial sleep deprivation (sleep restriction); Behavioral: Normal sleep |
| Study Sequence BA | Experimental | Normal sleep condition in the first period and sleep restriction condition in the second period. Each period will consist of a 10-day inpatient visit comprising a 3-day/2-night baseline, followed by a 5-day/5-night experimental phase, and a 2-day/2-night recovery phase. Receives: Behavioral: Partial sleep deprivation (sleep restriction); Behavioral: Normal sleep |
What is being measured
The primary outcome is the main question the study is designed to answer.
24-hour Systolic Blood Pressure (BP)
Systolic Blood pressure will be measured in mmHg
Measured: Day 2, Day 4, Day 7, and Day 9
Secondary outcomes (11)
24-hour Diastolic blood pressure (DBP)
Diastolic blood pressure will be measured in mmHg
Measured: Day 2, Day 4, Day 7, and Day 9
Awake Systolic Blood Pressure/Diastolic Blood Pressure (SBP/DBP)
Awake SBP/DBP will be measured in mmHg/mmHg
Measured: Day 2, Day 4, Day 7, and Day 9
Asleep Systolic Blood Pressure/Diastolic Blood Pressure (SBP/DBP)
Asleep SBP/DBP will be measured in mmHg/mmHg
Measured: Day 2, Day 4, Day 7, and Day 9
Systolic Blood Pressure/Diastolic Blood Pressure (SBP/DBP) Nocturnal dipping
SBP/DBP Nocturnal dipping will be measured in percent (%)
Measured: Day 2, Day 4, Day 7, and Day 9
Catecholamines
Catecholamines will be measured from a 24-hour urine collection.
Measured: Day 2, Day 4, Day 7, and Day 9
Baroreflex Sensitivity
Baroreflex Sensitivity will be measured from simultaneous electrocardiography (ECG) and noninvasive beat-to-beat BP recording.
Measured: Day 3, Day 5, Day 8, and Day 10
Endothelial Function
Endothelial function will be estimated from flow-mediated vasodilation using ultrasound.
Measured: Day 3, Day 5, Day 8, and Day 10
Blood Pressure (BP) response to stressors
BP response to stressors will be measured in mmHg
Measured: Day 3, Day 5, Day 8, and Day 10
Heart Rate response to stressors
Heart Rate response to stressors will be measured by ECG
Measured: Day 3, Day 5, Day 8, and Day 10
DNA-methylation
Methylated gene markers in peripheral blood mononuclear cells will be obtained
Measured: Day 3, Day 5, Day 8, and Day 10
Transcriptomic
Whole transcriptome in peripheral blood mononuclear cells will be obtained
Measured: Day 3, Day 5, Day 8, and Day 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2024
- Study start20 Feb 2025
- Primary completionApr 2029 (estimated)
- Study completionApr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Naima Covassin, Mayo Clinic
- Investigators
- Naima Covassin, Ph.D, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06482814
- Sponsor's protocol ID
- 24-001204
- Other IDs
- 1R01HL169320-01A1
- Status last verified
- Aug 2026
- First submitted
- 26 Jun 2024
- Last updated
- 13 Aug 2026
- Results posted
- No
- 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 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep Restriction and Parental History of Hypertension
- ClinicalTrials.gov ID
- NCT06482814
- Acronym / sponsor ID
- 24-001204
- Conditions
- Hypertension
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 20 Feb 2025 (actual)
- Primary completion
- Apr 2029 (estimated)
- Study completion
- Apr 2029 (estimated)
- First posted
- 1 Jul 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.
The purpose of this study is to research the effects of partial sleep deprivation (sleep restriction) in a group of individuals whose parents have high blood pressure compared to a group of individuals whose parents have normal blood pressure.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study Sequence AB | Experimental | Behavioral: Partial sleep deprivation (sleep restriction), Behavioral: Normal sleepSleep restriction condition in the first period and normal sleep condition in the second period. Each period will consist of a 10-day inpatient visit comprising a 3-day/2-night baseline, followed by a 5-day/5-night experimental phase, and a 2-day/2-night recovery phase. |
| Study Sequence BA | Experimental | Behavioral: Partial sleep deprivation (sleep restriction), Behavioral: Normal sleepNormal sleep condition in the first period and sleep restriction condition in the second period. Each period will consist of a 10-day inpatient visit comprising a 3-day/2-night baseline, followed by a 5-day/5-night experimental phase, and a 2-day/2-night recovery phase. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Healthy adults aged 18-35 years
- Absence of any significant medical or psychiatric disease (as per the investigators' judgment)
- Nonsmoker
- Nonpregnant
- History of normal sleep duration (reported average sleep duration between 7-9 hours/night and no habitual napping)
Key exclusion criteria (24 listed)
- Age <18 or >35 years
- Body mass index <18.5 or ≥30 kg/m2
- Pregnant or lactating
- Unable to determine history of HTN in participant's biological parents or subject being adopted
- Use of tobacco, vaping, marijuana products or other drugs
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 |
|---|---|---|
| Partial sleep deprivation (sleep restriction)During the experimental segment the sleep opportunity will be restricted to 5 hours/night. During the acclimation and recovery phases a 9-hour/night sleep opportunity will be provided. | Behavioural | Study Sequence AB, Study Sequence BA |
| Normal sleepDuring the normal sleep condition a 9-hour/night sleep opportunity will be provided throughout the 10-day inpatient visit. | Behavioural | Study Sequence AB, Study Sequence BA |
Primary outcome
24-hour Systolic Blood Pressure (BP)
Time frame: Day 2, Day 4, Day 7, and Day 9
Systolic Blood pressure will be measured in mmHg
11 secondary outcomes
24-hour Diastolic blood pressure (DBP)
Time frame: Day 2, Day 4, Day 7, and Day 9
Awake Systolic Blood Pressure/Diastolic Blood Pressure (SBP/DBP)
Time frame: Day 2, Day 4, Day 7, and Day 9
Asleep Systolic Blood Pressure/Diastolic Blood Pressure (SBP/DBP)
Time frame: Day 2, Day 4, Day 7, and Day 9
Systolic Blood Pressure/Diastolic Blood Pressure (SBP/DBP) Nocturnal dipping
Time frame: Day 2, Day 4, Day 7, and Day 9
Catecholamines
Time frame: Day 2, Day 4, Day 7, and Day 9
Baroreflex Sensitivity
Time frame: Day 3, Day 5, Day 8, and Day 10
Endothelial Function
Time frame: Day 3, Day 5, Day 8, and Day 10
Blood Pressure (BP) response to stressors
Time frame: Day 3, Day 5, Day 8, and Day 10
Heart Rate response to stressors
Time frame: Day 3, Day 5, Day 8, and Day 10
DNA-methylation
Time frame: Day 3, Day 5, Day 8, and Day 10
Transcriptomic
Time frame: Day 3, Day 5, Day 8, and Day 10
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2026.
- 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.
Naima Covassin, Ph.D 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 Partial sleep deprivation (sleep restriction) and Normal sleep in people with Hypertension, 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 8 inclusion and 24 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: looking for participants now, as of the sponsor's last update on 13 Aug 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sabah Munir ((507)255-0151, Munir.Sabah@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
24-hour Systolic Blood Pressure (BP) (time frame: Day 2, Day 4, Day 7, and Day 9). 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 13 Aug 2026.