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Sleep Duration and Blood Pressure During Sleep

Primary Purpose

Blood Pressure, Hypertension, Elevated Blood Pressure

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Sleep hygiene/extension intervention
Control care
Sponsored by
Columbia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Blood Pressure focused on measuring Nocturnal Hypertension, Short Sleep Duration, Cardiovascular Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • Columbia University Center for Behavioral Cardiovascular Health: CBCHRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Sleep Hygiene/Extension Intervention

Control Condition

Arm 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.

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.
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.
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.
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.

Full Information

First Posted
September 24, 2021
Last Updated
March 3, 2023
Sponsor
Columbia University
Collaborators
National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)
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1. Study Identification

Unique Protocol Identification Number
NCT05062161
Brief Title
Sleep Duration and Blood Pressure During Sleep
Official Title
Nocturnal Hypertension and Sleep (Sleep BP Study)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 30, 2021 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
February 28, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Columbia University
Collaborators
National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Blood Pressure, Hypertension, Elevated Blood Pressure, Sleep, Short Sleep Phenotype
Keywords
Nocturnal Hypertension, Short Sleep Duration, Cardiovascular Disease

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Masking Description
Participants will be randomized in a 1:1 ratio to each arm by a computer-generated random allocation sequence. All study investigators and outcome assessors will be blinded to group assignment and will not have access to the randomization sequence. The Educational Research Coordinator who will deliver the educational sessions will be unblinded to treatment arm but will not be involved in collecting study measures or data analyses.
Allocation
Randomized
Enrollment
66 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Sleep Hygiene/Extension Intervention
Arm Type
Experimental
Arm 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.
Arm Title
Control Condition
Arm Type
Active Comparator
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Sleep hygiene/extension intervention
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Control care
Intervention Description
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.
Primary Outcome Measure Information:
Title
Mean Sleep Systolic Blood Pressure (BP) at Baseline and 8 weeks
Description
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.
Time Frame
Baseline, 8 weeks
Title
Mean Sleep Diastolic Blood Pressure (BP) at Baseline and 8 weeks
Description
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.
Time Frame
Baseline, 8 weeks
Secondary Outcome Measure Information:
Title
Mean Awake Systolic Blood Pressure (BP) at Baseline and 8 weeks
Description
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
Title
Mean Awake Diastolic Blood Pressure (BP) at Baseline and 8 weeks
Description
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
Title
Mean 24-hour Systolic Blood Pressure (BP) at Baseline and 8 weeks
Description
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
Title
Mean 24-hour Diastolic Blood Pressure (BP) at Baseline and 8 weeks
Description
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.
Time Frame
Baseline, 8 weeks
Title
24-hour high frequency heart rate variability
Description
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.
Time Frame
Baseline, 8 weeks
Other Pre-specified Outcome Measures:
Title
Actigraphy-derived mean sleep duration
Description
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.
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marwah Abdalla, MD, MPH
Phone
212-342-1275
Email
ma2947@cumc.columbia.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Sumayya Shurovi
Phone
212-342-1275
Email
ss4978@cumc.columbia.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marwah Abdalla, MD, MPH
Organizational Affiliation
Assistant Professor of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Columbia University Center for Behavioral Cardiovascular Health: CBCH
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexandra Sullivan, MPH
Phone
212-342-4507
Email
as5068@cumc.columbia.edu
First Name & Middle Initial & Last Name & Degree
Study Line
Phone
646-413-3667
Email
cbch_sleep_ex_bp@cumc.columbia.edu
First Name & Middle Initial & Last Name & Degree
Marwah Abdalla, MD, MPH

12. IPD Sharing Statement

Plan to Share IPD
No

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