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Sleep Extension for High Blood Pressure

N/A

Waitlist Available

Led By Marwah Abdalla, MD, MPH

Research Sponsored by Columbia University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

English speaking adults

Age 18 and older

Must not have

Arm circumference >50 cm

End-stage renal disease (ESRD) on dialysis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 8 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial will look at how different sleep durations affect blood pressure levels while sleeping. The study will last 8 weeks and compare those who practice sleep hygiene with a control group.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this trial involves non-medical interventions like improving sleep habits, side effects are minimal but may include discomfort from wearing monitoring devices and changes in sleeping patterns.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am an adult who speaks English.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My arm circumference is more than 50 cm.

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I am on dialysis for end-stage kidney disease.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 8 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~8 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Mean Sleep Diastolic Blood Pressure (BP) at Baseline and 8 weeks

Mean Sleep Systolic Blood Pressure (BP) at Baseline and 8 weeks

Secondary study objectives

24-hour high frequency heart rate variability

Mean 24-hour Diastolic Blood Pressure (BP) at Baseline and 8 weeks

Mean 24-hour Systolic Blood Pressure (BP) at Baseline and 8 weeks

+2 more

Other study objectives

Actigraphy-derived mean sleep duration

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Sleep Hygiene/Extension InterventionExperimental Treatment1 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 ConditionActive Control1 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.

0 / 4Eligibility criteria met