Sleep Restriction and Parental History of Hypertension

Обзор

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.

Вмешательства

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

Первичные конечные точки

• 24-hour Systolic Blood Pressure (BP) [Срок оценки: Day 2, Day 4, Day 7, and Day 9]

Вторичные конечные точки (11)

• 24-hour Diastolic blood pressure (DBP) [Срок оценки: Day 2, Day 4, Day 7, and Day 9]
• Awake Systolic Blood Pressure/Diastolic Blood Pressure (SBP/DBP) [Срок оценки: Day 2, Day 4, Day 7, and Day 9]
• Asleep Systolic Blood Pressure/Diastolic Blood Pressure (SBP/DBP) [Срок оценки: Day 2, Day 4, Day 7, and Day 9]
• Systolic Blood Pressure/Diastolic Blood Pressure (SBP/DBP) Nocturnal dipping [Срок оценки: Day 2, Day 4, Day 7, and Day 9]
• Catecholamines [Срок оценки: Day 2, Day 4, Day 7, and Day 9]
• Baroreflex Sensitivity [Срок оценки: Day 3, Day 5, Day 8, and Day 10]
• Endothelial Function [Срок оценки: Day 3, Day 5, Day 8, and Day 10]
• Blood Pressure (BP) response to stressors [Срок оценки: Day 3, Day 5, Day 8, and Day 10]
• Heart Rate response to stressors [Срок оценки: Day 3, Day 5, Day 8, and Day 10]
• DNA-methylation [Срок оценки: Day 3, Day 5, Day 8, and Day 10]
• Transcriptomic [Срок оценки: Day 3, Day 5, Day 8, and Day 10]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Двойное слепое

Основная цель

Другое

Центры проведения

США · 1 центр

• Mayo Clinic in Rochester — Rochester

Идентификаторы

NCT: NCT06482814 · 24-001204 · 1R01HL169320-01A1

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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