Recruiting

Observational Study

Sponsor:

Mayo Clinic

Code:

NCT06482814

Conditions

Hypertension

Eligibility Criteria

Sex: All

Age: 18 - 35

Healthy Volunteers: Accepted

Interventions

Partial sleep deprivation (sleep restriction)

Normal sleep

Study Details

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 ID

NCT06482814

Start date

Feb 20, 2025

Status verified date

Aug, 2026

Completion date

Apr, 2029

Anticipated

Primary completion date

Apr, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 35

Healthy Volunteers: Accepted

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 Design

Enrollment

44 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Other

Interventions and Outcome Measures

Arms

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.

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.

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.

Normal sleep

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

Primary outcome measure

  • 24-hour Systolic Blood Pressure (BP) [ Time Frame: Day 2, Day 4, Day 7, and Day 9 ]

Central Contacts and Locations

Central contacts

Sabah Munir

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

Locations

Mayo Clinic in Rochester

Recruiting

Rochester, Minnesota, United States, 55905

Principal Investigator:

Naima Covassin

More Information

Sponsor

Mayo Clinic

Last update posted

Aug 13, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-08-13.