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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 weeks
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I am an adult who speaks English.
Select...
I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 8 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Mean Sleep Diastolic Blood Pressure (BP) at Baseline and 8 weeks
Mean Sleep Systolic Blood Pressure (BP) at Baseline and 8 weeks
Secondary outcome measures
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 moreOther outcome measures
Actigraphy-derived mean sleep duration
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.
Find a Location
Who is running the clinical trial?
Columbia UniversityLead Sponsor
1,431 Previous Clinical Trials
2,460,767 Total Patients Enrolled
National Institutes of Health (NIH)NIH
2,696 Previous Clinical Trials
6,952,522 Total Patients Enrolled
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,834 Previous Clinical Trials
47,309,430 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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.My arm circumference is more than 50 cm.You are at high risk of having obstructive sleep apnea, as determined by a specific questionnaire, a previous diagnosis, or the use of a continuous positive airway pressure device.You sleep less than 7 hours per night, as reported by yourself every day.I am a woman aged 45-65 experiencing hot flashes.I am an adult who speaks English.I am 18 years old or older.I am on dialysis for end-stage kidney disease.
Research Study Groups:
This trial has the following groups:- Group 1: Control Condition
- Group 2: Sleep Hygiene/Extension Intervention
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants is the research team recruiting for this trial?
"Affirmative. According to the information available on clinicaltrials.gov, enrollment is now open for this medical trial which was initially posted on September 30th 2021 and recently edited October 4th 2022. The research seeks 66 participants at a single site of study."
Answered by AI
Is there availability to enroll in this experimental protocol?
"According to clinicaltrials.gov, this medical study is still in need of participants and was originally posted on September 30th 2021. The trial details have been last revised on October 4th 2022."
Answered by AI
What are the principal aims of this trial?
"As the primary outcome, this trial will measure Mean Sleep Systolic Blood Pressure (BP) at Baseline and 8 weeks. Additionally, secondary outcomes of interest include Mean 24-hour Diastolic BP (mmHg), Mean 24-hour Systolic BP (mmHg), and Mean Awake Systolic BP (mmHg); all these metrics are to be tracked over a time course from Baseline to 8 weeks post therapy."
Answered by AI
Who else is applying?
What state do they live in?
New York
What portion of applicants met pre-screening criteria?
Met criteria
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