CompletedNot Applicable

Sleep Duration and Blood Pressure During Sleep

United States66 participantsStarted 2021-09-30

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: Baseline, 8 weeks

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

Timeframe: Baseline, 8 weeks

Trial details

NCT IDNCT05062161

SponsorColumbia University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-04-30

Results submitted2025-10-01

View on ClinicalTrials.gov More Blood Pressure trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.