Clinical trial NCT06482814: Sleep Restriction and Parental History of Hypertension
Official title: Sleep Restriction and Parental History of Hypertension
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hypertension
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2024-07-01
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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.


Eligibility criteria: 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)
* Both biological parents with medical records from Mayo Clinic or Rochester Epidemiology Project
* 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 hypertension 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 systolic/diastolic blood pressure (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
* Habitual high levels of physical activity (\>3000 MET×minutes/week)125
* 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.

Primary outcomes:
measure: 24-hour Systolic Blood Pressure (BP)
timeFrame: Day 2, Day 4, Day 7, and Day 9
Secondary outcomes:
measure: 24-hour Diastolic blood pressure (DBP)
timeFrame: Day 2, Day 4, Day 7, and Day 9
measure: Awake Systolic Blood Pressure/Diastolic Blood Pressure (SBP/DBP)
timeFrame: Day 2, Day 4, Day 7, and Day 9
measure: Asleep Systolic Blood Pressure/Diastolic Blood Pressure (SBP/DBP)
timeFrame: Day 2, Day 4, Day 7, and Day 9
measure: Systolic Blood Pressure/Diastolic Blood Pressure (SBP/DBP) Nocturnal dipping
timeFrame: Day 2, Day 4, Day 7, and Day 9
measure: Catecholamines
timeFrame: Day 2, Day 4, Day 7, and Day 9
measure: Baroreflex Sensitivity
timeFrame: Day 3, Day 5, Day 8, and Day 10
measure: Endothelial Function
timeFrame: Day 3, Day 5, Day 8, and Day 10
measure: Blood Pressure (BP) response to stressors
timeFrame: Day 3, Day 5, Day 8, and Day 10
measure: Heart Rate response to stressors
timeFrame: Day 3, Day 5, Day 8, and Day 10
measure: DNA-methylation
timeFrame: Day 3, Day 5, Day 8, and Day 10
measure: Transcriptomic
timeFrame: Day 3, Day 5, Day 8, and Day 10
Other outcomes:
measure: Arterial Tonometry
timeFrame: Day 3, Day 5, Day 8, and Day 10
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Naima Covassin, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: