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Recruiting NCT06482814

Sleep Restriction and Parental History of Hypertension

No phase Interventional Hypertension

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Partial sleep deprivation (sleep restriction), Normal sleep.
Who it may be relevant to
Registry conditions: Hypertension. Basic parameters: 18 years — 35 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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

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

Primary outcome measures

  • 24-hour Systolic Blood Pressure (BP) [Time frame: Day 2, Day 4, Day 7, and Day 9]
Secondary outcome measures (11)
  • 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]

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)
  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Crossover
Masking
Double blind
Primary purpose
Other

Study locations

United States · 1 center
  • Mayo Clinic in Rochester — Rochester

Identifiers

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

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗