Sleep Duration and Blood Pressure During Sleep

Columbia University

Status: Completed

Conditions: Short Sleep Phenotype; Hypertension; Elevated Blood Pressure; Sleep; Blood Pressure

Treatments: Behavioral: Control care; Behavioral: Sleep hygiene/extension intervention

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05062161

AAAT8157

K23HL141682-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 66 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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66 participants in 2 patient groups

Sleep Hygiene/Extension Intervention

Experimental group

Description:

Participants with short sleep duration will receive a 60-minute educational session on sleep hygiene/extension. Over an 8-week period, participants will receive weekly phone or Zoom video calls from the Educational Research Coordinator to review additional materials including handouts and/or complete questionnaires about sleep. Participants will undergo sleep tracking/monitoring during the 8-week period, and repeat BP/heart rate monitoring for 24 hours after the 8-week period.

Treatment:

Behavioral: Sleep hygiene/extension intervention

Control Condition

Active Comparator group

Description:

Participants with short sleep duration will receive a 60-minute educational session on sleep physiology. Over an 8-week period, participants will receive weekly phone or Zoom video calls from the Educational Research Coordinator to review additional materials including handouts. Participants will undergo sleep tracking/monitoring during the 8-week period, and repeat BP/heart rate monitoring for 24 hours after the 8-week period.

Treatment:

Behavioral: Control care