Sleep Restriction and Parental History of Hypertension

Mayo Clinic

Status: Enrolling

Conditions: Hypertension

Treatments: Behavioral: Normal sleep; Behavioral: Partial sleep deprivation (sleep restriction)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06482814

1R01HL169320-01A1 (U.S. NIH Grant/Contract)

24-001204

Details and patient eligibility

About

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.

Enrollment: 44 estimated patients

Sex: All

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

---

44 participants in 2 patient groups

Study Sequence AB

Experimental group

Description:

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.

Treatment:

Behavioral: Partial sleep deprivation (sleep restriction)

Behavioral: Normal sleep

Study Sequence BA

Experimental group

Description:

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.

Treatment:

Behavioral: Partial sleep deprivation (sleep restriction)

Behavioral: Normal sleep