Sleep Restriction and Parental History of Hypertension | NCT06482814

NCT06482814

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

ID	Type	Description	Link
1R01HL169320-01A1	U.S. NIH Grant/Contract		View source

Status Module

Name	Class
National Heart, Lung, and Blood Institute (NHLBI)	NIH

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

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 Outcomes

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

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

Eligibility Module

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.

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases