Nocturnal Hypertension and Sleep (Sleep BP Study)
Phase: NA
Conditions: Blood Pressure, Hypertension, Elevated Blood Pressure, Sleep, Short Sleep Phenotype
Sponsor: Columbia University

 
 
 
 
 
 
 
 
Nocturnal Hypertension and Sleep (Sleep BP Study) 
 
 
 
NCT05062161 
 
July 11, 2025 
 
 

 
1. Study Purpose and Rationale 
The purpose of this study is to examine the impact that sleep duration has on blood pressure 
levels during sleep. We will examine the effect of an 8-week sleep hygiene/extension 
intervention vs. control on sleep blood pressure.  
 
Background: 
Blood pressure varies across the day, typically highest when awake and lower during sleep. 
Elevated nighttime blood pressure (nocturnal hypertension, defined as sleep blood pressure 
≥110/65 mmHg) and reduced nighttime declines in blood pressure (“non-dipping”) are linked to 
higher risks of cardiovascular disease, target organ damage, and mortality. These patterns are 
present in 30–45% of the general population, but optimal strategies to address them remain 
unclear. 
 
Short sleep duration, defined as fewer than 7 hours per night, affects more than one-third of 
U.S. adults and is associated with obesity, diabetes, hypertension, and increased mortality. 
Prior studies show that insufficient sleep is linked to higher nighttime blood pressure and non-
dipping patterns. Experimental sleep restriction raises blood pressure, but there is limited 
evidence on whether extending sleep improves nighttime blood pressure. Small clinical studies 
suggest potential benefits, but these were conducted in specialized settings and relied on less 
widely validated measures. This study will build on that work by testing whether sleep 
extension in daily life can lower nighttime blood pressure. 
 
2. Study Design 
Up to 66 participants will be enrolled following a two-step screening process: (1) completion of 
initial questionnaires, and (2) a two-week period of daily self-reported sleep assessments. 
Those meeting eligibility criteria will be consented and undergo a baseline visit. Baseline clinic 
blood pressure will be measured with a validated automated device after a 5-minute rest. All 
participants will complete questionnaires and be fitted with devices for sleep tracking, 24-hour 
ambulatory blood pressure monitoring, and 24-hour heart rate monitoring.  Participants return 
the 24-hour devices and are then randomized 1:1 to either a sleep hygiene/extension education 
program or control education. Depending on group assignment, participants will attend a 60-
minute educational session on either sleep hygiene/extension strategies or general sleep 
physiology. Over the 8-week study period, participants will receive weekly phone or video 
check-ins, complete questionnaires, and review progress and study materials. At the end of the 
study, participants will repeat the 24-hour blood pressure and heart rate monitoring before 
returning study devices. 
 
3. Statistical Procedures 
Sample size calculations used a two-sided alpha of 5% and 80% statistical power. Enrolling 66 
participants will provide a final sample size of 52, assuming 10% attrition and 10% with 
incomplete data. With this sample size, we will have 80% statistical power to detect a change in 
mean sleep systolic blood pressure and diastolic blood pressure between participants 
randomized to sleep hygiene/extension intervention vs. control. Mean sleep systolic and 

 
diastolic blood pressure will be calculated at baseline and follow-up for participants randomized 
to sleep extension and sleep maintenance, separately. The change in mean sleep blood 
pressure from baseline to follow-up (the difference between baseline and follow-up sleep 
blood pressure) will be calculated and compared across randomization arms using a t-test. 
4. Recruitment: Participants will be recruited through multiple approaches (e.g., flyers, 
community events).  
 
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 sleep 
monitoring device 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