NCT05062161

Sleep Duration and Blood Pressure During Sleep

Nocturnal Hypertension and Sleep (Sleep BP Study)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 66 (actual)
• Sponsor: Columbia University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Blood Pressure
• Hypertension
• Elevated Blood Pressure
• Sleep
• Short Sleep Phenotype

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2021-09-30
• Primary completion: 2024-04-30
• Completion: 2024-12-31
• First posted: 2021-09-30
• Last updated: 2025-10-20
• Results posted: 2025-10-20

Locations

1 site across 1 country: United States