Sleep Restriction and Parental History of Hypertension

NCT06482814 | Recruiting

• 2 other identifiers: 24-0012041R01HL169320-01A1
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

• 24-hour Systolic Blood Pressure (BP)

  Systolic Blood pressure will be measured in mmHg

  Day 2, Day 4, Day 7, and Day 9

Secondary Outcomes (11)

• 24-hour Diastolic blood pressure (DBP)

  Day 2, Day 4, Day 7, and Day 9

• Awake Systolic Blood Pressure/Diastolic Blood Pressure (SBP/DBP)

  Day 2, Day 4, Day 7, and Day 9

• Asleep Systolic Blood Pressure/Diastolic Blood Pressure (SBP/DBP)

  Day 2, Day 4, Day 7, and Day 9

• Systolic Blood Pressure/Diastolic Blood Pressure (SBP/DBP) Nocturnal dipping

  Day 2, Day 4, Day 7, and Day 9

• Catecholamines

  Day 2, Day 4, Day 7, and Day 9

Other Outcomes (1)

• Arterial Tonometry

  Day 3, Day 5, Day 8, and Day 10

Study Arms (2)

Study Sequence AB

EXPERIMENTAL

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); Behavioral: Normal sleep

Study Sequence BA

EXPERIMENTAL

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); Behavioral: Normal sleep

Interventions

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.

Study Sequence AB; Study Sequence BA

Normal sleep BEHAVIORAL

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

Study Sequence AB; Study Sequence BA

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Mayo Clinic: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

RECRUITING

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Naima Covassin, Ph.D

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sabah Munir

CONTACT

(507)255-0151; Munir.Sabah@mayo.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 26, 2024
• First Posted: July 1, 2024
• Study Start: February 20, 2025
• Primary Completion (Estimated): April 1, 2029
• Study Completion (Estimated): April 1, 2029
• Last Updated: August 1, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)