NCT06285968 The DREAM Study: A Multidimensional Sleep Health Intervention for Improving Cardiometabolic Health
| NCT ID | NCT06285968 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Columbia University |
| Condition | Blood Pressure |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2024-03-12 |
| Primary Completion | 2027-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 200 participants in total. It began in 2024-03-12 with a primary completion date of 2027-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of this randomized clinical trial is to evaluate the impact of a multidimensional sleep health promotion intervention on blood pressure, glycemic control indicators, anthropometric markers of adiposity, and lifestyle factors in adults. Participants will be randomized into an intervention or a control group. The control arm will receive standard Life's Essential 8 cardiovascular health educational materials. The intervention arm will additionally receive a multi-component intervention aimed at improving sleep health based on evidence-based sleep hygiene education and established behavior change techniques that include personalized sleep health feedback, goal setting and establishing a sleep health plan, coaching, self-monitoring, and addressing light and noise in the sleep environment. Mixed methods will be used to understand implementation determinants, processes, and outcomes, ensuring the successful completion and future expansion of this intervention.
Eligibility Criteria
Inclusion Criteria: * Adults aged 30+ years * English or Spanish speaking * Systolic blood pressure greater than or equal to 120 mmHg * Sub-optimal sleep health * No history of overt cardiovascular disease * No history of cancer Exclusion Criteria: * Optimal sleep health * History of cardiovascular disease or cancer * Non-English or non-Spanish speaking * Not cognitively able to complete study requirements * Severe psychiatric disorders * Inability to provide informed consent
Contact & Investigator
Nour Makarem, PhD
PRINCIPAL INVESTIGATOR
Columbia University
Frequently Asked Questions
Who can join the NCT06285968 clinical trial?
This trial is open to participants of all sexes, aged 30 Years or older, studying Blood Pressure. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06285968 currently recruiting?
Yes, NCT06285968 is actively recruiting participants. Contact the research team at dream@cumc.columbia.edu for enrollment information.
Where is the NCT06285968 trial being conducted?
This trial is being conducted at New York, United States.
Who is sponsoring the NCT06285968 clinical trial?
NCT06285968 is sponsored by Columbia University. The principal investigator is Nour Makarem, PhD at Columbia University. The trial plans to enroll 200 participants.