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Completed

NCT Number: NCT05062161

Sleep Duration and Blood Pressure During Sleep

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.

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Key information

Conditions

Blood Pressure Cardiovascular Diseases Elevated Blood Pressure Hypertension Mental Disorders Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Short Sleep Phenotype Signs and Symptoms Sleep Sleep Wake Disorders Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Columbia University Center for Behavioral Cardiovascular Health: CBCH

New York, 10032, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  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.

  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.

Secondary outcomes

  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 outcomes

  1. Actigraphy-derived Mean Sleep Duration

    Time frame: Baseline, 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.

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)
  • National Institutes of Health (NIH)

Registry information

Official study title

Nocturnal Hypertension and Sleep (Sleep BP Study)

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Sep 30, 2021
Registry last updated
Jun 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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