Sleep Restriction and Parental History of Hypertension

NCT ID: NCT06482814

Last Updated: 2025-08-01

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-20
• Study Completion Date: 2029-04-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Partial sleep deprivation (sleep restriction)

Intervention Type: 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

Intervention Type: BEHAVIORAL

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

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.

Group Type: EXPERIMENTAL

Partial sleep deprivation (sleep restriction)

Intervention Type: 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

Intervention Type: BEHAVIORAL

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

Interventions

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.

Intervention Type: BEHAVIORAL

Normal sleep

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

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Naima Covassin

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Naima Covassin, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Sabah Munir

Role: CONTACT

Munir.Sabah@mayo.edu

(507)255-0151

Other Identifiers

1R01HL169320-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

24-001204

Identifier Type: -

Identifier Source: org_study_id