Multidimensional Sleep Health Intervention for Couples
This study is testing a Multidimensional Sleep Health Promotion Intervention to see if it can improve sleep and blood pressure in couples. The intervention uses educational materials from the American Heart Association (AHA) and an 8-week program focusing on sleep hygiene and behavior changes. You might be able to join if you are 30-65 years old, speak English, and are part of a couple where at least one person has a systolic blood pressure of 120 mmHg or higher and/or suboptimal sleep. You cannot join if you have optimal sleep, a history of heart disease or cancer, or cannot understand the study. The study aims to see if this intervention improves sleep health and blood pressure. The current recruitment status is unclear.
- Study design
- This is an interventional study with a planned enrollment of 50 participants. It is a single-arm study, meaning there is no control group.
- What's involved
- The intervention lasts 8 weeks. Your blood pressure and sleep health will be measured at the beginning and after 8 weeks.
- Compensation
- Not stated in the trial record.
- Follow-up
- You will be followed for 8 weeks after the start of the intervention to measure changes in blood pressure and sleep health.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Multidimensional Sleep Health Intervention for Couples
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Nour Makarem, PhD · PRINCIPAL_INVESTIGATOR · Columbia University
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Inclusion
Exclusion
What this trial measures
- Change in office systolic blood pressureBaseline, 8 weeks
The change in office systolic blood pressure (mmHg) from baseline to follow-up at 8 weeks will be calculated and compared across dyads.
- Change in office diastolic blood pressureBaseline, 8 weeks
The change in office diastolic blood pressure (mmHg) from baseline to follow-up at 8 weeks will be calculated and compared across dyads.
- Change in multidimensional sleep healthBaseline, 8 weeks
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.
- Change in sleep durationBaseline, 8 weeks
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.
- Change in sleep regularityBaseline, 8 weeks
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 standard deviation (SD) and sleep timing SD (continuous variable) from baseline to 8 weeks will be assessed.
- Changes in sleep efficiencyBaseline, 8 weeks
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.
- Changes in sleep timingBaseline, 8 weeks
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.
- Changes in sleep alertnessBaseline, 8 weeks
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.
- Change in sleep satisfactionBaseline, 8 weeks
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.
- Change in subjective sleep qualityBaseline, 8 weeks, 16 weeks
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.
- Change in daytime blood pressure (during wake)Baseline, 8 weeks
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.
- Change in nighttime blood pressure (during sleep)Baseline, 8 weeks
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.
- Change in mean 24-hour blood pressureBaseline, 8 weeks
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.