Sleep Duration and Blood Pressure During Sleep

NCT05062161 | Completed Results

• 2 other identifiers: AAAT8157K23HL141682-01
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Nocturnal Hypertension; Short Sleep Duration; Cardiovascular Disease

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Baseline, 8 weeks

Secondary Outcomes (5)

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

  Baseline, 8 weeks

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

  Baseline, 8 weeks

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

  Baseline, 8 weeks

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

  Baseline, 8 weeks

• 24-hour High Frequency Heart Rate Variability

  Baseline, 8 weeks

Other Outcomes (1)

• Actigraphy-derived Mean Sleep Duration

  8 weeks

Study Arms (2)

Sleep Hygiene/Extension Intervention

EXPERIMENTAL

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

Control Condition

ACTIVE COMPARATOR

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

Interventions

Sleep hygiene/extension intervention BEHAVIORAL

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.

Sleep Hygiene/Extension Intervention

Control care BEHAVIORAL

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.

Control Condition

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• English speaking adults
• Age 18 and older
• Sleep duration \< 7 hours per night as assessed via daily self-report of sleep hours

You may not qualify if:

• 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

Sponsors & Collaborators

• Columbia University: lead
• National Institutes of Health (NIH): collaborator
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Columbia University Center for Behavioral Cardiovascular Health: CBCH

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Hypertension; Sleep Wake Disorders; Cardiovascular Diseases

Interventions

sodium bicarbonate-based toothpaste

Condition Hierarchy (Ancestors)

Vascular Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Results Point of Contact

• Title: Marwah Abdalla
• Organization: Columbia University Medical Center

ma2947@cumc.columbia.edu

212 342 1275

Study Officials

• Marwah Abdalla, MD, MPH

  Columbia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: September 24, 2021
• First Posted: September 30, 2021
• Study Start: September 30, 2021
• Primary Completion: April 30, 2024
• Study Completion: December 31, 2024
• Last Updated: October 20, 2025
• Results First Posted: October 20, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)