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Sleep Duration and Blood Pressure During Sleep

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ClinicalTrials.gov Identifier: NCT05062161
Recruitment Status : Recruiting
First Posted : September 30, 2021
Last Update Posted : October 5, 2022
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Marwah Abdalla, Columbia University

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.

Condition or disease Intervention/treatment Phase
Blood Pressure Hypertension Elevated Blood Pressure Sleep Short Sleep Phenotype Behavioral: Sleep hygiene/extension intervention Behavioral: Control care Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes 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.
Primary Purpose: Supportive Care
Official Title: Nocturnal Hypertension and Sleep (Sleep BP Study)
Actual Study Start Date : September 30, 2021
Estimated Primary Completion Date : November 30, 2023
Estimated Study Completion Date : February 28, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Healthy Sleep

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.




Primary Outcome Measures :
  1. Mean Sleep Systolic Blood Pressure (BP) at Baseline and 8 weeks [ Time Frame: Baseline, 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.

  2. Mean Sleep Diastolic Blood Pressure (BP) at Baseline and 8 weeks [ Time Frame: Baseline, 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 :
  1. Mean Awake Systolic Blood Pressure (BP) at Baseline and 8 weeks [ Time Frame: Baseline, 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.

  2. Mean Awake Diastolic Blood Pressure (BP) at Baseline and 8 weeks [ Time Frame: Baseline, 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.

  3. Mean 24-hour Systolic Blood Pressure (BP) at Baseline and 8 weeks [ Time Frame: Baseline, 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.

  4. Mean 24-hour Diastolic Blood Pressure (BP) at Baseline and 8 weeks [ Time Frame: Baseline, 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.

  5. 24-hour high frequency heart rate variability [ Time Frame: Baseline, 8 weeks ]
    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.


Other Outcome Measures:
  1. Actigraphy-derived mean sleep duration [ Time Frame: 8 weeks ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05062161


Contacts
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Contact: Marwah Abdalla, MD, MPH 212-342-1275 ma2947@cumc.columbia.edu
Contact: Sumayya Shurovi 212-342-1275 ss4978@cumc.columbia.edu

Locations
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United States, New York
Columbia University Center for Behavioral Cardiovascular Health: CBCH Recruiting
New York, New York, United States, 10032
Contact: Alexandra Sullivan, MPH    212-342-4507    as5068@cumc.columbia.edu   
Contact: Study Line    646-413-3667    cbch_sleep_ex_bp@cumc.columbia.edu   
Principal Investigator: Marwah Abdalla, MD, MPH         
Sponsors and Collaborators
Columbia University
National Institutes of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
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Principal Investigator: Marwah Abdalla, MD, MPH Assistant Professor of Medicine
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Responsible Party: Marwah Abdalla, Assistant Professor of Medicine, Columbia University
ClinicalTrials.gov Identifier: NCT05062161    
Other Study ID Numbers: AAAT8157
K23HL141682-01 ( U.S. NIH Grant/Contract )
First Posted: September 30, 2021    Key Record Dates
Last Update Posted: October 5, 2022
Last Verified: October 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Marwah Abdalla, Columbia University:
Nocturnal Hypertension
Short Sleep Duration
Cardiovascular Disease
Additional relevant MeSH terms:
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Sleep Wake Disorders
Hypertension
Vascular Diseases
Cardiovascular Diseases
Nervous System Diseases
Neurologic Manifestations
Mental Disorders