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NCT Number: NCT06482814

Sleep Restriction and Parental History of Hypertension

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.

Recruiting

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Key information

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location status: Recruiting

Location contact

Naima Covassin

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Partial sleep deprivation (sleep restriction)

Behavioral

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 sleep

Behavioral

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

Primary outcomes

  1. 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

Secondary outcomes

  1. 24-hour Diastolic blood pressure (DBP)

    Time frame: Day 2, Day 4, Day 7, and Day 9

    Diastolic blood pressure will be measured in mmHg

  2. Awake Systolic Blood Pressure/Diastolic Blood Pressure (SBP/DBP)

    Time frame: Day 2, Day 4, Day 7, and Day 9

    Awake SBP/DBP will be measured in mmHg/mmHg

  3. Asleep Systolic Blood Pressure/Diastolic Blood Pressure (SBP/DBP)

    Time frame: Day 2, Day 4, Day 7, and Day 9

    Asleep SBP/DBP will be measured in mmHg/mmHg

  4. Systolic Blood Pressure/Diastolic Blood Pressure (SBP/DBP) Nocturnal dipping

    Time frame: Day 2, Day 4, Day 7, and Day 9

    SBP/DBP Nocturnal dipping will be measured in percent (%)

  5. Catecholamines

    Time frame: Day 2, Day 4, Day 7, and Day 9

    Catecholamines will be measured from a 24-hour urine collection.

  6. Baroreflex Sensitivity

    Time frame: Day 3, Day 5, Day 8, and Day 10

    Baroreflex Sensitivity will be measured from simultaneous electrocardiography (ECG) and noninvasive beat-to-beat BP recording.

  7. Endothelial Function

    Time frame: Day 3, Day 5, Day 8, and Day 10

    Endothelial function will be estimated from flow-mediated vasodilation using ultrasound.

  8. Blood Pressure (BP) response to stressors

    Time frame: Day 3, Day 5, Day 8, and Day 10

    BP response to stressors will be measured in mmHg

  9. Heart Rate response to stressors

    Time frame: Day 3, Day 5, Day 8, and Day 10

    Heart Rate response to stressors will be measured by ECG

  10. DNA-methylation

    Time frame: Day 3, Day 5, Day 8, and Day 10

    Methylated gene markers in peripheral blood mononuclear cells will be obtained

  11. Transcriptomic

    Time frame: Day 3, Day 5, Day 8, and Day 10

    Whole transcriptome in peripheral blood mononuclear cells will be obtained

Other outcomes

  1. Arterial Tonometry

    Time frame: Day 3, Day 5, Day 8, and Day 10

    Pulse wave velocity will be measured by Applanation tonometry

Study contacts

Contact information is provided by the study sponsor or research team.

Sabah Munir

CONTACT

[email protected]

(507)255-0151

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Important dates

Study start
2025
Primary completion
2029
Study completion
2029
First posted
Jul 1, 2024
Registry last updated
Aug 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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