An interventional study of Sleep hygiene/extension intervention and Control care in Blood Pressure, Hypertension and Elevated Blood Pressure, sponsored by Columbia University. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-08.
Sponsored by Columbia University · Not applicable, Interventional, and Supportive care
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.
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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Exclusion Criteria:
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
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 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.
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.
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.
Time frame: 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.
Time frame: Baseline, 8 weeks
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, 8 weeks
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.
Time frame: Baseline, 8 weeks
| Milestone | Sleep Hygiene/Extension Intervention | Control Condition |
|---|---|---|
| Started | 32 | 33 |
| Completed | 32 | 33 |
| Not completed | 0 | 0 |
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.
| mmHg | Control Condition | Sleep Hygiene/Extension Intervention |
|---|---|---|
| Baseline | 100.8 ± 13.3 | 100.0 ± 9.1 |
| 8 Weeks | 101.4 ± 13.2 | 102.3 ± 12.7 |
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.
| mmHg | Control Condition | Sleep Hygiene/Extension Intervention |
|---|---|---|
| Baseline | 58.6 ± 8.2 | 57.9 ± 6.5 |
| 8 weeks | 60.0 ± 7.8 | 60.1 ± 6.4 |
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.
| mmHg | Control Condition | Sleep Hygiene/Extension Intervention |
|---|---|---|
| Baseline | 117.8 ± 11.6 | 119.7 ± 8.8 |
| 8 weeks | 115.9 ± 13.1 | 119.2 ± 12.2 |
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.
| mmHg | Control Condition | Sleep Hygiene/Extension Intervention |
|---|---|---|
| Baseline | 73.5 ± 8.0 | 75.7 ± 6.8 |
| 8 weeks | 72.7 ± 7.6 | 74.6 ± 7.5 |
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.
| mmHg | Control Condition | Sleep Hygiene/Extension Intervention |
|---|---|---|
| Baseline | 113.2 ± 12.3 | 114.4 ± 8.5 |
| 8 weeks | 111.6 ± 12.6 | 114.1 ± 12.0 |
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.
| mmHg | Control Condition | Sleep Hygiene/Extension Intervention |
|---|---|---|
| Baseline | 69.4 ± 7.9 | 70.9 ± 6.3 |
| 8 weeks | 68.9 ± 6.9 | 70.4 ± 6.7 |
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.
| ms^2 | Control Condition | Sleep Hygiene/Extension Intervention |
|---|---|---|
| Baseline | 680.3 ± 749.3 | 510.6 ± 360.0 |
| 8 weeks | 737.6 ± 839.8 | 574.9 ± 550.9 |
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.
| hours | Control Condition | Sleep Hygiene/Extension Intervention |
|---|---|---|
| Baseline | 7.16 ± 2.14 | 7.28 ± 1.58 |
| 8 weeks | 7.26 ± 2.02 | 6.72 ± 1.84 |
Collected over 8 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Control Condition | 0/33 (0%) | 0/33 (0%) | 0/33 (0%) |
| Sleep Hygiene/Extension Intervention | 0/32 (0%) | 0/32 (0%) | 0/32 (0%) |
| Age, Continuous(years) | Control Condition | Sleep Hygiene/Extension Intervention | Total |
|---|---|---|---|
| Mean | 37.9 ± 16.6 | 36.7 ± 15.1 | 37.3 ± 15.8 |
| Sex: Female, Male(Participants) | Control Condition | Sleep Hygiene/Extension Intervention | Total |
|---|---|---|---|
| Female | 19 | 19 | 38 |
| Male | 14 | 13 | 27 |
| Ethnicity (NIH/OMB)(Participants) | Control Condition | Sleep Hygiene/Extension Intervention | Total |
|---|---|---|---|
| Hispanic or Latino | 10 | 7 | 17 |
| Not Hispanic or Latino | 23 | 24 | 47 |
| Unknown or Not Reported | 0 | 1 | 1 |
| Race (NIH/OMB)(Participants) | Control Condition | Sleep Hygiene/Extension Intervention | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 10 | 11 | 21 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 8 | 7 | 15 |
| White | 10 | 9 | 19 |
| More than one race | 2 | 1 | 3 |
| Unknown or Not Reported | 3 | 4 | 7 |
| Region of Enrollment(participants) | Control Condition | Sleep Hygiene/Extension Intervention | Total |
|---|---|---|---|
| United States | 33 | 32 | 65 |
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