Recruiting

MDSH Intervention

Sponsor:

Columbia University

Code:

NCT07603245

Conditions

Blood Pressure

Sleep

Cardiovascular Health

Eligibility Criteria

Sex: All

Age: 30 - 65

Healthy Volunteers: Accepted

Interventions

Multidimensional Sleep Health Promotion Intervention

Study Details

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.

Conditions

Blood Pressure

Sleep

Cardiovascular Health

Study ID

NCT07603245

Start date

Jun 8, 2026

Status verified date

Aug, 2026

Completion date

Jun, 2027

Anticipated

Primary completion date

Jun, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 30 - 65

Healthy Volunteers: Accepted

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

Study Design

Enrollment

50 participants

Anticipated

Intervention Model

Single group

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Multidimensional Sleep Health (MDSH) Promotion Intervention

Dyads will receive:

1. An 8-week multi-component multidimensional sleep health promotion intervention that includes: report back of objectively-assessed sleep health profiles, goal setting and dyadic MDSH planning, behavioral coaching (enhancing dyadic coping, communication, collaborative support) and sleep health education sessions, self-monitoring and motivational enhancement using a Fitbit and a participant manual, and inexpensive place-based solutions for light and noise as key upstream barriers to healthy sleep in urban settings.
2. Cardiovascular health education materials based on the American Heart Association's Life's Essential 8 framework.

Interventions

Multidimensional Sleep Health Promotion Intervention

Standard American Heart Association (AHA) Life's Essential 8 (LE8) cardiovascular health educational materials and the 8-week MDSH intervention using evidence-based sleep hygiene education and established behavior change techniques that include: report back of objectively-assessed sleep health profiles, goal setting and dyadic MDSH planning, behavioral coaching (enhancing dyadic coping, communication, collaborative support) and sleep health education sessions, self-monitoring and motivational enhancement using a Fitbit, weekly check-in calls, and a participant sleep health manual, and inexpensive place-based solutions for light, and noise as key upstream barriers to healthy sleep in urban settings.

Primary outcome measure

  • Change in office systolic blood pressure [ Time Frame: Baseline, 8 weeks ]
  • Change in office diastolic blood pressure [ Time Frame: Baseline, 8 weeks ]
  • Change in multidimensional sleep health [ Time Frame: Baseline, 8 weeks ]
  • Change in sleep duration [ Time Frame: Baseline, 8 weeks ]
  • Change in sleep regularity [ Time Frame: Baseline, 8 weeks ]
  • Changes in sleep efficiency [ Time Frame: Baseline, 8 weeks ]
  • Changes in sleep timing [ Time Frame: Baseline, 8 weeks ]
  • Changes in sleep alertness [ Time Frame: Baseline, 8 weeks ]
  • Change in sleep satisfaction [ Time Frame: Baseline, 8 weeks ]
  • Change in subjective sleep quality [ Time Frame: Baseline, 8 weeks, 16 weeks ]
  • Change in daytime blood pressure (during wake) [ Time Frame: Baseline, 8 weeks ]
  • Change in nighttime blood pressure (during sleep) [ Time Frame: Baseline, 8 weeks ]
  • Change in mean 24-hour blood pressure [ Time Frame: Baseline, 8 weeks ]

Central Contacts and Locations

Central contacts

Locations

Columbia University

Recruiting

New York, New York, United States, 10032

Contacts

More Information

Sponsor

Columbia University

Last update posted

Sep 1, 2026

Last verified

Aug, 2026

Keywords

  • Blood Pressure
  • Sleep
  • Cardiovascular Health
  • Couples
  • Dyads

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 2026-09-01.