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.

Study Overview

• Status: Recruiting
• Conditions: Hypertension
• Intervention / Treatment: Behavioral: Partial sleep deprivation (sleep restriction); Behavioral: Normal sleep

• Study Type: Interventional
• Enrollment (Estimated): 44
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sabah Munir; Phone Number: (507)255-0151; Email: Munir.Sabah@mayo.edu

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Recruiting
      • Mayo Clinic in Rochester
      • Principal Investigator: Naima Covassin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Study Sequence AB; Sleep restriction condition in the first period and normal sleep condition in the second period. Each period will consist of a 10-day inpatient visit comprising a 3-day/2-night baseline, followed by a 5-day/5-night experimental phase, and a 2-day/2-night recovery phase.	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.
Experimental: Study Sequence BA; Normal sleep condition in the first period and sleep restriction condition in the second period. Each period will consist of a 10-day inpatient visit comprising a 3-day/2-night baseline, followed by a 5-day/5-night experimental phase, and a 2-day/2-night recovery phase.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
24-hour Systolic Blood Pressure (BP)	Systolic Blood pressure will be measured in mmHg	Day 2, Day 4, Day 7, and Day 9

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Arterial Tonometry	Pulse wave velocity will be measured by Applanation tonometry	Day 3, Day 5, Day 8, and Day 10

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
• Investigators: Principal Investigator: Naima Covassin, Ph.D, Mayo Clinic

Study record dates

Study Major Dates

• Study Start (Actual): February 20, 2025
• Primary Completion (Estimated): April 1, 2029
• Study Completion (Estimated): April 1, 2029

Study Registration Dates

• First Submitted: June 26, 2024
• First Submitted That Met QC Criteria: June 26, 2024
• First Posted (Actual): July 1, 2024

Study Record Updates

• Last Update Posted (Actual): August 1, 2025
• Last Update Submitted That Met QC Criteria: July 30, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Hypertension
• Other Study ID Numbers: 24-001204; 1R01HL169320-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No