Sleep Duration and Blood Pressure During Sleep

Nocturnal Hypertension and Sleep (Sleep BP Study)

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.

Study Overview

• Status: Recruiting
• Conditions: Hypertension; Sleep; Blood Pressure; Elevated Blood Pressure; Short Sleep Phenotype
• Intervention / Treatment: Behavioral: Sleep hygiene/extension intervention; Behavioral: Control care

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.

• Study Type: Interventional
• Enrollment (Anticipated): 66
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marwah Abdalla, MD, MPH; Phone Number: 212-342-1275; Email: ma2947@cumc.columbia.edu
• Study Contact Backup: Name: Sumayya Shurovi; Phone Number: 212-342-1275; Email: ss4978@cumc.columbia.edu

Study Locations

• United States
  • New York
    • New York, New York, United States, 10032
      • Recruiting
      • Columbia University Center for Behavioral Cardiovascular Health: CBCH
      • Contact: Alexandra Sullivan, MPH; Phone Number: 212-342-4507; Email: as5068@cumc.columbia.edu
      • Contact: Study Line; Phone Number: 646-413-3667; Email: cbch_sleep_ex_bp@cumc.columbia.edu
      • Principal Investigator: Marwah Abdalla, MD, MPH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sleep Hygiene/Extension Intervention; 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.	Behavioral: Sleep hygiene/extension intervention; 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.
Active Comparator: Control Condition; 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.	Behavioral: Control care; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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. The change in mean sleep systolic BP from baseline to follow-up (baseline minus follow-up sleep systolic BP) will be calculated and compared across randomization arms.	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. The change in mean sleep diastolic BP from baseline to follow-up (baseline minus follow-up sleep diastolic BP) will be calculated and compared across randomization arms.	Baseline, 8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	Baseline, 8 weeks
24-hour high frequency heart rate variability	24-hour high frequency heart rate variability will be estimated from R-R interval data from the Cardio SOLO device at baseline and 8 weeks and compared across randomization arms.	Baseline, 8 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Actigraphy-derived mean sleep duration	This is to measure if the intervention (sleep hygiene/extension) would increase mean sleep duration for participants randomized to sleep hygiene/extension, actigraphy-derived sleep duration will be used to evaluate the intervention. Actigraphy-derived mean sleep duration will be calculated daily as the total time between the sleep and awake period as defined on the Fitbit device in number of hours.	8 weeks

Collaborators and Investigators

• Sponsor: Columbia University
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI); National Institutes of Health (NIH)
• Investigators: Principal Investigator: Marwah Abdalla, MD, MPH, Assistant Professor of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): September 30, 2021
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): February 28, 2024

Study Registration Dates

• First Submitted: September 24, 2021
• First Submitted That Met QC Criteria: September 24, 2021
• First Posted (Actual): September 30, 2021

Study Record Updates

• Last Update Posted (Estimate): March 6, 2023
• Last Update Submitted That Met QC Criteria: March 3, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Cardiovascular Disease; Nocturnal Hypertension; Short Sleep Duration
• Additional Relevant MeSH Terms: Mental Disorders; Cardiovascular Diseases; Vascular Diseases; Nervous System Diseases; Neurologic Manifestations; Hypertension; Sleep Wake Disorders
• Other Study ID Numbers: AAAT8157; K23HL141682-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No