Clinical trial NCT05062161: Sleep Duration and Blood Pressure During Sleep
Official title: Nocturnal Hypertension and Sleep (Sleep BP Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Blood Pressure
Hypertension
Elevated Blood Pressure
Sleep
Short Sleep Phenotype
Keywords: Nocturnal Hypertension
Short Sleep Duration
Cardiovascular Disease
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2021-09-30
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to examine the impact that sleep duration has on blood pressure (BP) levels during sleep. The investigator will examine the effect of an 8-week sleep hygiene/extension intervention vs. control on sleep BP.

Detailed description: Short sleep duration (SSD), defined as sleeping less than 7 hours per night, affects over 33% of US adults and is associated with increased mortality. SSD is a modifiable risk factor for obesity, type 2 diabetes, and HTN. Cross-sectional studies have demonstrated that SSD is associated with higher sleep BP levels. SSD is also associated with non-dipping BP which is primarily explained by higher sleep BP levels. However, many of the cross-sectional studies have included adolescent participants or have not used reference standard measures of sleep duration such as wrist actigraphy. Manipulating sleep duration experimentally through sleep restriction or deprivation is associated with higher 24-hour and sleep BP levels. In contrast, there is scarce data on the effect of sleep extension on sleep BP levels among adults with SSD.

Eligible community individuals with short sleep duration will be randomized to sleep extension vs. control using 24-hour ambulatory blood pressure monitoring (ABPM) and actigraphy in the naturalistic environment. Individuals will be assessed throughout the study using questionnaires, activity monitoring via a Fitbit device (for 8 weeks), blood pressure monitoring using a 24-hour ABPM device, and heart rate variability monitoring for 24-hours.

Eligibility criteria: Inclusion Criteria:

* English speaking adults
* Age 18 and older
* Sleep duration \< 7 hours per night as assessed via daily self-report of sleep hours

Exclusion Criteria:

* Inability to read or write in English
* Pregnant or plans to get pregnant within study period
* Arm circumference \>50 cm
* Lymphedema of the arm or unable to wear ABPM device for 24 hours or wrist actigraphy for 8 weeks
* End-stage renal disease (ESRD) on dialysis
* Unreliable internet or phone/text access
* High risk of Obstructive Sleep Apnea (OSA) (using the Berlin Questionnaire or diagnosis of OSA or use continuous positive airway pressure device)
* High risk of insomnia (using the Insomnia Severity Index), or a known prior history of insomnia, and/or use of prescription sleep aides
* High risk of depression (using the Patient Health Questionnaire Depression Scale: PHQ-8)
* Perimenopausal women who have hot flashes (using the Menopause Rating Scale (MRS) questionnaire, administered only to females age 45-65)
* Plan to travel out of state and/or internationally during the study period

Primary outcomes:
measure: Mean Sleep Systolic Blood Pressure (BP) at Baseline and 8 weeks
timeFrame: Baseline, 8 weeks
measure: Mean Sleep Diastolic Blood Pressure (BP) at Baseline and 8 weeks
timeFrame: Baseline, 8 weeks
Secondary outcomes:
measure: Mean Awake Systolic Blood Pressure (BP) at Baseline and 8 weeks
timeFrame: Baseline, 8 weeks
measure: Mean Awake Diastolic Blood Pressure (BP) at Baseline and 8 weeks
timeFrame: Baseline, 8 weeks
measure: Mean 24-hour Systolic Blood Pressure (BP) at Baseline and 8 weeks
timeFrame: Baseline, 8 weeks
measure: Mean 24-hour Diastolic Blood Pressure (BP) at Baseline and 8 weeks
timeFrame: Baseline, 8 weeks
measure: 24-hour high frequency heart rate variability
timeFrame: Baseline, 8 weeks
Other outcomes:
measure: Actigraphy-derived mean sleep duration
timeFrame: 8 weeks
Locations:
city: New York
country: United States
facility: Columbia University Center for Behavioral Cardiovascular Health: CBCH
state: New York
Study officials:
affiliation: Assistant Professor of Medicine
name: Marwah Abdalla, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: