Recruiting

Sleep Health Promotion

Sponsor:

Columbia University

Code:

NCT06285968

Conditions

Blood Pressure

Eligibility Criteria

Sex: All

Age: 30+

Healthy Volunteers: Accepted

Interventions

Multidimensional Sleep Health Promotion Intervention

Study Details

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.

Conditions

Blood Pressure

Study ID

NCT06285968

Start date

Mar 12, 2024

Status verified date

May, 2026

Completion date

Jun 30, 2027

Anticipated

Primary completion date

Jun 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 30+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Multidimensional Sleep Health Promotion Intervention

Participants randomized to the intervention arm will receive:

1. A multi-component multidimensional sleep health promotion intervention that includes report back of sleep health profiles, S.M.A.R.T. goal setting, sleep health coaching, establishment of fixed sleep schedule, virtual sleep hygiene education, self-monitoring, personalized feedback and supportive accountability, and addressing light and noise in the sleep environment.
2. Cardiovascular health education materials based on the American Heart Association's Life's Essential 8 framework.

no intervention: Standard of care

Participants randomized to the control arm will receive standard American Heart Association Life's Essential 8 cardiovascular health education materials, providing guidance on healthy sleep duration only.

Interventions

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 measure

  • Change in office systolic blood pressure [ Time Frame: Baseline, 8 weeks ]

Central Contacts and Locations

Central contacts

Research Project Coordinator

212-305-3317dream@cumc.columbia.edu

Nour Makarem, PhD

nm2968@cumc.columbia.edu

Locations

Columbia University Irving Medical Center, Mailman School of Public Health

Recruiting

New York, New York, United States, 10032

Contacts

Nour Makarem, PhD

nm2968@cumc.columbia.edu

More Information

Sponsor

Columbia University

Last update posted

May 29, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Columbia University on 2026-05-29.