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Behavioral Intervention

Multidimensional Sleep Health Promotion Intervention for High Blood Pressure

N/A
Recruiting
Led By Nour Makarem, PhD
Research Sponsored by Columbia University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Adults aged 30-65 years
No history of overt cardiovascular disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 weeks and 24 weeks
Awards & highlights

Study Summary

This trial aims to study the effects of a program designed to improve sleep health on blood pressure, blood sugar control, weight, and lifestyle habits in Hispanic/Latino adults. Participants will be divided into

Who is the study for?
This trial is for Hispanic/Latina/o/x adults with high blood pressure. Participants should be interested in improving their sleep health to potentially better their heart health and lifestyle factors. Details on specific inclusion or exclusion criteria are not provided, but typically these would outline who can safely participate.Check my eligibility
What is being tested?
The study tests a special program designed to help people sleep better and see if it improves blood pressure and other health markers related to diabetes and weight. Half the participants will get this new sleep improvement program, while the other half will receive standard heart health information.See study design
What are the potential side effects?
Since this intervention focuses on non-medical approaches like education, coaching, and environmental adjustments for better sleep, significant side effects are not expected. However, individual experiences may vary.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 30 and 65 years old.
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I have never had heart disease.
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I have never had cancer before.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 weeks and 24 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 weeks and 24 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in office systolic blood pressure
Secondary outcome measures
Acceptability of Implementation
Appropriateness of Implementation
Change in body weight
+8 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Multidimensional Sleep Health Promotion InterventionExperimental Treatment1 Intervention
Participants randomized to the intervention arm will receive: A multi-component multidimensional sleep health promotion intervention that includes virtual sleep health and sleep hygiene education, personalized feedback and establishment of a sleep health plan, behavioral coaching, self-monitoring, supportive accountability, and addressing light and noise in the sleep environment. Cardiovascular health education materials based on the American Heart Association's Life's Essential 8 framework.
Group II: Standard of careActive Control1 Intervention
Participants randomized to the control arm will receive standard American Heart Association Life's Essential 8 cardiovascular health education materials.

Find a Location

Who is running the clinical trial?

Columbia UniversityLead Sponsor
1,433 Previous Clinical Trials
2,447,009 Total Patients Enrolled
National Institute on Minority Health and Health Disparities (NIMHD)NIH
383 Previous Clinical Trials
1,216,109 Total Patients Enrolled
Nour Makarem, PhDPrincipal InvestigatorColumbia University

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current number of individuals being enrolled in this research investigation?

"Affirmative. Data available on clinicaltrials.gov shows that this medical investigation is presently seeking eligible participants. Initially uploaded on March 1st, 2024, the trial's most recent update was made on February 28th, 2024. The research aims to enroll a total of 250 patients at one designated site."

Answered by AI

Are there any ongoing efforts to enroll participants in this current medical study?

"Per clinicaltrials.gov, this study is actively enrolling subjects. It was initially posted on March 1st, 2024, and last revised on February 28th of the same year."

Answered by AI

Does this research include individuals older than two decades?

"To be eligible for participation in this research study, individuals must fall between the ages of 30 and 65. Notably, there are currently 8 ongoing trials targeting those below 18 years old and an additional 82 studies focusing on participants above the age of 65."

Answered by AI

Who else is applying?

What site did they apply to?
Columbia University Irving Medical Center, Mailman School of Public Health
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
The DREAM Study: A Multidimensional Sleep Health Intervention for Reducing Cardiometabolic Health Inequities
Nour Makarem, PhD 2024. "The DREAM Study: A Multidimensional Sleep Health Intervention for Reducing Cardiometabolic Health Inequities". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06285968.
~167 spots leftby Mar 2026
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