N/A N=65 Randomized Double-blind Supportive Care

Sleep Duration and Blood Pressure During Sleep

Blood Pressure · Hypertension · Elevated Blood Pressure · Sleep · Short Sleep Phenotype

Bottom Line

View on ClinicalTrials.gov: NCT05062161 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Oct 2025

Primary outcome: Primary: Mean Sleep Systolic Blood Pressure (BP) at Baseline and 8 Weeks — 100.8; 100.0; 101.4; 102.3 mmHg

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Sleep hygiene/extension intervention (Behavioral); Control care (Behavioral)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Columbia University
Primary completion: Apr 2024

Outcome Measures

Outcome	Result	p-value
PRIMARY Mean Sleep Systolic Blood Pressure (BP) at Baseline and 8 Weeks	100.8; 100.0; 101.4; 102.3	—
PRIMARY Mean Sleep Diastolic Blood Pressure (BP) at Baseline and 8 Weeks	58.6; 57.9; 60.0; 60.1	—
SECONDARY Mean Awake Systolic Blood Pressure (BP) at Baseline and 8 Weeks	—	—
SECONDARY Mean Awake Diastolic Blood Pressure (BP) at Baseline and 8 Weeks	—	—
SECONDARY Mean 24-hour Systolic Blood Pressure (BP) at Baseline and 8 Weeks	—	—
SECONDARY Mean 24-hour Diastolic Blood Pressure (BP) at Baseline and 8 Weeks	—	—
SECONDARY 24-hour High Frequency Heart Rate Variability	—	—

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.

Eligibility Criteria

Inclusion Criteria

English speaking adults
Age 18 and older
Sleep duration 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05062161). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.