Sleep Extension for High Blood Pressure

Overseen By Sumayya Shurovi

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Columbia University

Must not be taking: Prescription sleep aides

Disqualifiers: Pregnancy, ESRD, OSA, insomnia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 9

Duration: 8 weeks

66 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Marwah Abdalla, MD, MPH

Principal Investigator

Assistant Professor of Medicine

Eligibility Criteria

This trial is for English-speaking adults over 18 who sleep less than 7 hours a night. It's not suitable for those with arm circumference >50 cm, end-stage renal disease, high risk of sleep apnea or insomnia, depression, perimenopausal women with hot flashes, or if pregnant/planning to be within the study period.

Inclusion Criteria

You sleep less than 7 hours per night, as reported by yourself every day.

Exclusion Criteria

You have a high risk of depression based on a questionnaire called the PHQ-8.

I have a high risk of insomnia or have used prescription sleep aids.

You have swelling in your arm or cannot wear a device for a certain amount of time.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo an 8-week sleep hygiene/extension intervention or control condition with weekly phone or Zoom calls, sleep tracking, and monitoring

8 weeks

8 visits (virtual)

Follow-up

Participants are monitored for changes in blood pressure and heart rate variability after the intervention

1 week

1 visit (in-person)

Treatment Details

Interventions

• Control care
• Sleep hygiene/extension intervention

Trial Overview The study compares an 8-week program designed to improve sleep habits and extend sleep time against usual care to see how it affects blood pressure during sleep.

Participant Groups

Group I: Sleep Hygiene/Extension Intervention Experimental Treatment 1 Intervention

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.

Group II: Control Condition Active Control 1 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.

Who Is Running the Clinical Trial?

Columbia University

Lead Sponsor

Trials

1,529

Recruited

2,832,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+