NCT07603245 Multidimensional Sleep Health Intervention for Couples
| NCT ID | NCT07603245 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Columbia University |
| Condition | Blood Pressure |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2026-06-08 |
| Primary Completion | 2027-06 |
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 50 participants in total. It began in 2026-06-08 with a primary completion date of 2027-06.
⚠ 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 goal of this pilot dyadic study is to adapt a multidimensional sleep health (MDSH) intervention, previously disseminated at the individual level, for relationship partners, determine whether it improves sleep health and aspects of cardiometabolic health, and understand the role of dyadic dynamics in intervention effects. Can a dyadic MDSH intervention improve sleep health and blood pressure (primary outcomes) in relationship partners? Can a dyadic MDSH intervention improve anthropometric markers of adiposity, psychosocial indicators, stress, dyadic adjustment and coping, self-rated health (secondary outcomes) in relationship partners? As this is a single-arm study, there is no control group. All relationship partners will complete a three-tier screening process, attend two in-person visits to receive intervention materials, have blood pressure measured and sleep data collected using in-office and out-of-office monitors, participate in weekly check-in phone calls with research staff over the 8 weeks to support adherence and complete a voluntary follow-up phone call at 16 weeks to provide additional sleep health information. The multidimensional sleep health promotion intervention is based on evidence-based sleep hygiene education and established behavior change techniques and includes: report-back of sleep health profiles, S.M.A.R.T (specific, measurable, attainable, realistic, and timely) goal-setting and establishing a sleep health plan with a fixed sleep schedule, sleep health coaching and dyadic action planning, self-monitoring, virtual sleep hygiene education, motivational feedback, and addressing light and noise in the sleep environment. Mixed methods will be used to understand implementation metrics, processes, and outcomes to establish the successful completion and future expansion of the intervention within this context.
Eligibility Criteria
Inclusion Criteria: * Adults aged 30-65 years * English-speaking * Sub-optimal sleep health (at minimum one individual has to meet: short/long sleep duration and/or irregular sleep patterns) Exclusion Criteria: * Optimal sleep health * History of cardiovascular disease or cancer * Not cognitively able to complete study requirements * Known medical conditions that would prevent them from safely participating in the study (severe psychiatric disorders, neurological degenerative disease, substance abuse/dependence) * History of severe depression * High risk of sleep apnea or use of a Continuous Positive Airway Pressure (CPAP) device * Inability to provide informed consent
Contact & Investigator
Nour Makarem, PhD
PRINCIPAL INVESTIGATOR
Columbia University
Frequently Asked Questions
Who can join the NCT07603245 clinical trial?
This trial is open to participants of all sexes, aged 30 Years or older, up to 65 Years, 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 NCT07603245 currently recruiting?
Yes, NCT07603245 is actively recruiting participants. Contact the research team at dream@cumc.columbia.edu for enrollment information.
Where is the NCT07603245 trial being conducted?
This trial is being conducted at New York, United States.
Who is sponsoring the NCT07603245 clinical trial?
NCT07603245 is sponsored by Columbia University. The principal investigator is Nour Makarem, PhD at Columbia University. The trial plans to enroll 50 participants.