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Sleep Restriction and Parental History of Hypertension

Sleep Restriction and Parental History of Hypertension

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06482814
Enrollment
44
Registered
2024-07-01
Start date
2025-02-20
Completion date
2029-04-30
Last updated
2025-08-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension

Brief 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.

Interventions

BEHAVIORALPartial 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.

BEHAVIORALNormal sleep

During the normal sleep condition a 9-hour/night sleep opportunity will be provided throughout the 10-day inpatient visit.

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)
CollaboratorNIH
Mayo Clinic
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 35 Years
Healthy volunteers
Yes

Inclusion criteria

* 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

Exclusion criteria

* 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) * 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.

Design outcomes

Primary

MeasureTime frameDescription
24-hour Systolic Blood Pressure (BP)Day 2, Day 4, Day 7, and Day 9Systolic Blood pressure will be measured in mmHg

Secondary

MeasureTime frameDescription
24-hour Diastolic blood pressure (DBP)Day 2, Day 4, Day 7, and Day 9Diastolic blood pressure will be measured in mmHg
Awake Systolic Blood Pressure/Diastolic Blood Pressure (SBP/DBP)Day 2, Day 4, Day 7, and Day 9Awake SBP/DBP will be measured in mmHg/mmHg
Asleep Systolic Blood Pressure/Diastolic Blood Pressure (SBP/DBP)Day 2, Day 4, Day 7, and Day 9Asleep SBP/DBP will be measured in mmHg/mmHg
Systolic Blood Pressure/Diastolic Blood Pressure (SBP/DBP) Nocturnal dippingDay 2, Day 4, Day 7, and Day 9SBP/DBP Nocturnal dipping will be measured in percent (%)
CatecholaminesDay 2, Day 4, Day 7, and Day 9Catecholamines will be measured from a 24-hour urine collection.
Endothelial FunctionDay 3, Day 5, Day 8, and Day 10Endothelial function will be estimated from flow-mediated vasodilation using ultrasound.
Blood Pressure (BP) response to stressorsDay 3, Day 5, Day 8, and Day 10BP response to stressors will be measured in mmHg
Heart Rate response to stressorsDay 3, Day 5, Day 8, and Day 10Heart Rate response to stressors will be measured by ECG
DNA-methylationDay 3, Day 5, Day 8, and Day 10Methylated gene markers in peripheral blood mononuclear cells will be obtained
TranscriptomicDay 3, Day 5, Day 8, and Day 10Whole transcriptome in peripheral blood mononuclear cells will be obtained
Baroreflex SensitivityDay 3, Day 5, Day 8, and Day 10Baroreflex Sensitivity will be measured from simultaneous electrocardiography (ECG) and noninvasive beat-to-beat BP recording.

Other

MeasureTime frameDescription
Arterial TonometryDay 3, Day 5, Day 8, and Day 10Pulse wave velocity will be measured by Applanation tonometry

Countries

United States

Contacts

Primary ContactSabah Munir
Munir.Sabah@mayo.edu(507)255-0151

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026