Sleep Duration and Blood Pressure During Sleep

Columbia University66 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

DOUBLE

Enrollment

Conditions

Blood Pressure Hypertension Elevated Blood Pressure Sleep Short Sleep Phenotype

Interventions

Sleep hygiene/extension interventionBEHAVIORAL

The 60-minute sleep hygiene/extension educational session include the following: This session will consist of questionnaires, handouts, videos, and a discussion. Topic examples include information on establishing a comfortable sleep environment, including strategies on how to extend sleep duration by a maximum of 1 hour over the duration of the 8-week trial for an average of 7.5 minutes per week, not to exceed 15 minutes per week. Participants will also receive educational brochures and a sleep diary.

Control careBEHAVIORAL

The 60-minute educational session will address sleep physiology but not sleep hygiene. This session will consist of questionnaires, handouts, videos, and a discussion. Participants will receive an educational brochure.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Columbia University Center for Behavioral Cardiovascular Health: CBCH

New York, New York, United States

Outcomes

Primary Outcomes

Mean Sleep Systolic Blood Pressure (BP) at Baseline and 8 Weeks

Mean of valid BP readings during the sleep period on 24-hour ambulatory blood pressure monitor will be calculated to obtain mean sleep systolic BP (mmHg) at baseline and 8 weeks.

Time frame: Baseline, 8 weeks

Mean Sleep Diastolic Blood Pressure (BP) at Baseline and 8 Weeks

Mean of valid BP readings during the sleep period on 24-hour ambulatory blood pressure monitor will be calculated to obtain mean sleep diastolic BP (mmHg) at baseline and 8 weeks.

Time frame: Baseline, 8 weeks

Secondary Outcomes

Mean Awake Systolic Blood Pressure (BP) at Baseline and 8 Weeks

Mean of valid BP readings during the awake period on 24-hour ambulatory blood pressure monitor will be calculated to obtain mean awake systolic BP (mmHg) at baseline and 8 weeks.

Time frame: Baseline, 8 weeks

Mean Awake Diastolic Blood Pressure (BP) at Baseline and 8 Weeks

Mean of valid BP readings during the awake period on 24-hour ambulatory blood pressure monitor will be calculated to obtain mean awake diastolic BP (mmHg) at baseline and 8 weeks.

Time frame: Baseline, 8 weeks

Mean 24-hour Systolic Blood Pressure (BP) at Baseline and 8 Weeks

Mean of valid BP readings during the awake period on 24-hour ambulatory blood pressure monitor will be calculated to obtain mean awake 24-hour systolic BP (mmHg) at baseline and 8 weeks.

Time frame: Baseline, 8 weeks

Mean 24-hour Diastolic Blood Pressure (BP) at Baseline and 8 Weeks

Mean of valid BP readings during the awake period on 24-hour ambulatory blood pressure monitor will be calculated to obtain mean awake 24-hour diastolic BP (mmHg) at baseline and 8 weeks.

Data from ClinicalTrials.gov

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