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Recruiting NCT06285968

The DREAM Study: A Multidimensional Sleep Health Intervention for Improving Cardiometabolic Health

No phase Interventional Blood Pressure

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Multidimensional Sleep Health Promotion Intervention.
Who it may be relevant to
Registry conditions: Blood Pressure. Basic parameters: from 30 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Addressing Sleep Duration, Regularity, and Efficiency: A Multidimensional Sleep Health Intervention for Improving Cardiometabolic Health (The DREAM Study)

Overview

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.

Detailed description

Improving multiple domains of cardiometabolic health through contextual behavioral interventions can have far-reaching effects for reducing the burden of multiple cardiometabolic morbidities. Despite a strong evidence base supporting the role of sleep as a major contributor to cardiometabolic health preservation, most lifestyle interventions have targeted diet or physical activity and not sleep. Sleep is amenable to intervention and can improve cardiometabolic health through complementary or synergistic biologic pathways with other lifestyle factors. Therefore, pragmatic multidimensional sleep health interventions may elucidate scalable and sustainable contextual behavioral approaches to improve cardiometabolic health and extend healthspan.

Interventions

  • Behavioral Multidimensional Sleep Health Promotion Intervention
    Multi-component multidimensional sleep health promotion intervention that includes goal setting, action planning, sleep health coaching and sleep hygiene education, a fixed sleep schedule, self-monitoring, personalized feedback and supportive accountability, and addressing light and noise in the sleep environment.

Primary outcome measures

  • Change in office systolic blood pressure [Time frame: Baseline, 8 weeks]
Secondary outcome measures (12)
  • Change in office systolic blood pressure (sustained effect at 24 weeks) [Time frame: Baseline, 24 weeks]
  • Change in office diastolic blood pressure [Time frame: Baseline, 8 weeks, and 24 weeks]
  • Change in daytime blood pressure (during wake) [Time frame: Baseline, 8 weeks, and 24 weeks]
  • Change in nighttime blood pressure (during sleep) [Time frame: Baseline, 8 weeks, 24 weeks]
  • Change in mean 24-hour blood pressure [Time frame: Baseline, 8 weeks, 24 weeks]
  • Change in fasting glucose [Time frame: Baseline, 8 weeks, and 24 weeks]
  • Change in body weight [Time frame: Baseline, 8 weeks, and 24 weeks]
  • Change in waist circumference [Time frame: Baseline, 8 weeks, and 24 weeks]
  • Change in diet quality [Time frame: Baseline, 8 weeks, and 24 weeks]
  • Change in multidimensional sleep health [Time frame: Baseline, 8 weeks, and 24 weeks]
  • Changes in sleep duration [Time frame: Baseline, 8 weeks, 24 weeks]
  • Changes in sleep regularity [Time frame: Baseline, 8 weeks, 24 weeks]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

United States · 1 center
  • Columbia University Irving Medical Center, Mailman School of Public Health — New York

Identifiers

NCT: NCT06285968 · AAAU8937 · P50MD017341

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗