Multidimensional Sleep Health Intervention for Couples

NCT07603245 | Not Yet Recruiting

• 1 other identifier: AAAW0053
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Keywords

Blood Pressure; Sleep; Cardiovascular Health; Couples; Dyads

Outcome Measures

Primary Outcomes (13)

• Change in office systolic blood pressure

  The change in office systolic blood pressure (mmHg) from baseline to follow-up at 8 weeks will be calculated and compared across dyads.

  Baseline, 8 weeks

• Change in office diastolic blood pressure

  The change in office diastolic blood pressure (mmHg) from baseline to follow-up at 8 weeks will be calculated and compared across dyads.

  Baseline, 8 weeks

• Change in multidimensional sleep health

  Sleep health will be assessed using sleep duration, regularity, efficiency, and timing from wrist actigraphy and self-reported sleep satisfaction and alertness (measured by daytime sleepiness). Optimal sleep health will be defined as having an average sleep duration (hours/night) ≥ 7 hours and \< 9 hours, regular sleep duration and timing (standard deviation of sleep duration and timing variables \< 60 minutes), sleep efficiency (%) ≥ 85%, an earlier sleep period (sleep midpoint earlier than 4:00 AM), normal daytime sleepiness (Epworth Sleepiness Scale ≤ 10), and good self-rated sleep satisfaction or quality. Each individual component will receive a score of 1 if it meets the optimal sleep health definition or a score of 0 if it does not. Scores will range from 0-6, where higher scores (closer to 6) are defined as healthier sleep. Changes in the sleep health score (cumulative dimensions) from baseline to 8 weeks will be assessed.

  Baseline, 8 weeks

• Change in sleep duration

  Sleep duration will be assessed from wrist actigraphy. Optimal sleep duration will be defined as having an average sleep duration (hours/night) ≥ 7 hours and \< 9 hours, given a score of 1 if met or 0 if not. Changes in sleep duration (continuous variable) from baseline to 8 weeks will be assessed.

  Baseline, 8 weeks

• Change in sleep regularity

  Sleep regularity will be assessed from wrist actigraphy. Optimal sleep regularity will be defined as having a standard deviation of sleep duration and timing variables \< 60 minutes, given a score of 1 if met or 0 if not. Changes in sleep duration SD and sleep timing SD (continuous variable) from baseline to 8 weeks will be assessed.

  Baseline, 8 weeks

• Changes in sleep efficiency

  Sleep efficiency will be assessed from wrist actigraphy. Optimal sleep efficiency will be defined as having an average sleep efficiency (%) ≥ 85%, given a score of 1 if met or 0 if not. Changes in sleep efficiency (continuous variable) from baseline to 8 weeks will be assessed.

  Baseline, 8 weeks

• Changes in sleep timing

  Sleep timing will be assessed from wrist actigraphy. Optimal sleep timing will be defined as having an earlier sleep period (sleep midpoint earlier than 4:00 AM), given a score of 1 if met or 0 if not. Changes in sleep timing (continuous variable) from baseline to 8 weeks will be assessed.

  Baseline, 8 weeks

• Changes in sleep alertness

  Sleep alertness will be assessed from the self reported Epworth Sleepiness Scale (ESS). Optimal sleep alertness will be defined as having normal daytime sleepiness (ESS ≤ 10). Scores range from 0-24, where a score ≥ 11 indicated excessive daytime sleepiness. Changes in the ESS score (continuous variable) from baseline to 8 weeks will be assessed.

  Baseline, 8 weeks

• Change in sleep satisfaction

  Sleep satisfaction will be assessed from the consensus sleep diary. Sleep satisfaction is measured on a Likert scale (1 = very poor; 2 = poo; 3 = fair; 4 = good; 5 = very good). Change in sleep satisfaction from baseline and 8 weeks will be assessed.

  Baseline, 8 weeks

• Change in subjective sleep quality

  Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI), which captures seven clinical components (subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, daytime dysfunction) over the past month. The PSQI score ranges from 0-21 with higher scores suggesting significant sleep difficulties. The change in PSQI scores from baseline to follow-up at 8 weeks will be computed.

  Baseline, 8 weeks, 16 weeks

• Change in daytime blood pressure (during wake)

  Mean daytime blood pressure (mean of blood pressure readings during the wake period) will be computed using valid readings from 24-h ambulatory blood pressure monitoring. Changes in out-of-office daytime blood pressure metrics from baseline to follow-up at 8 weeks will be calculated.

  Baseline, 8 weeks

• Change in nighttime blood pressure (during sleep)

  Mean nighttime blood pressure (mean of blood pressure readings during the sleep period) will be computed using valid readings from 24-h ambulatory blood pressure monitoring. Changes in these out-of-office nighttime blood pressure metrics from baseline to follow-up at 8 weeks will be calculated.

  Baseline, 8 weeks

• Change in mean 24-hour blood pressure

  Mean 24-h blood pressure (mean of the wake and sleep blood pressure values, weighted by the relative amounts of time spent awake and asleep) will be computed using valid readings from 24-h ambulatory blood pressure monitoring. Changes in these out-of-office blood pressure metrics from baseline to follow-up at 8 weeks will be calculated and compared across dyads.

  Baseline, 8 weeks

Secondary Outcomes (13)

• Change in body weight

  Baseline, 8 weeks

• Change in waist circumference

  Baseline, 8 weeks

• Change in diet quality

  Baseline, 8 weeks

• Change in perceived stress

  Baseline, 8 weeks

• Change in anxiety severity

  Baseline, 8 weeks

Study Arms (1)

Multidimensional Sleep Health Promotion Intervention

EXPERIMENTAL

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.

Behavioral: Multidimensional Sleep Health Promotion Intervention

Interventions

Multidimensional Sleep Health Promotion Intervention BEHAVIORAL

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.

Multidimensional Sleep Health Promotion Intervention

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 30-65 years
• English-speaking
• Systolic blood pressure greater than or equal to 120 mmHg (at minimum one individual in dyad)
• Sub-optimal sleep health (at minimum short/long sleep duration and/or irregular sleep patterns)

You may not qualify if:

• 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 or high risk of sleep apnea/use of a Continuous Positive Airway Pressure (CPAP) device
• Inability to provide informed consent

Sponsors & Collaborators

• Columbia University: lead

Study Sites (1)

Columbia University

New York, New York, 10032, United States

Location

Study Officials

• Nour Makarem, PhD

  Columbia University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Research Team

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 13, 2026
• First Posted: May 22, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: May 22, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)