Ta strona została przetłumaczona automatycznie i dokładność tłumaczenia nie jest gwarantowana. Proszę odnieść się do angielska wersja za tekst źródłowy.

Multidimensional Sleep Health Intervention for Couples (DREAM-COUPLES)

31 sierpnia 2026 zaktualizowane przez: Nour Makarem, PhD, Columbia University

DREAM-COUPLES: A Dyadic Multidimensional Sleep Health Intervention

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.

Przegląd badań

Status

Rekrutacyjny

Warunki

Interwencja / Leczenie

Szczegółowy opis

Sleep is a critical determinant of cardiometabolic health (CMH), yet most lifestyle interventions have focused exclusively on diet and physical activity, ignoring sleep as a modifiable behavioral target. There are limited behavioral sleep health interventions for improving CMH. To address this, the investigators developed the DREAM intervention, a multilevel multi-component intervention leveraging evidence-based behavior change techniques and addressing both individual behaviors and the sleep environment. To extend this work, the investigators are adapting the DREAM intervention to cohabitating couples, recognizing the critical role of dyadic dynamics in shaping sleep health and the importance of relationship partners in influencing each other's health behaviors.

This study will investigate whether a dyadic multidimensional sleep health (MDSH) intervention delivered to cohabitating relationship partners can improve objectively measured sleep health and cardiometabolic outcomes, including office and out-of-office blood pressure (BP) and anthropometric markers of adiposity. This study will also examine the intervention's effects on stress, psychosocial indicators, dyadic adjustment and coping, and self-rated health. The hypothesis is that targeting multiple interrelated sleep dimensions and leveraging health-promoting dyadic dynamics as a sustainable social support mechanism will improve MDSH and CMH.

This is a single arm, pre-post design intervention study. There is no randomization or control arm, and all eligible couples will receive the MDSH intervention. The study consists of three phases:

Screening Phase: Online/phone questionnaire screening followed by an in-person blood pressure assessment and 7-day sleep assessment (actigraphy and sleep diary) to confirm eligibility.

Intervention Phase (8 weeks): Eligible couples receive the full MDSH intervention, and complete two in-person visits at baseline and 8-weeks (endpoint).

Follow-Up Phase (16 weeks): A follow-up phone call is conducted at 16 weeks post-enrollment to collect sleep health information and assess sustainability of intervention effects.

Typ studiów

Interwencyjne

Zapisy (Szacowany)

50

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Lokalizacje studiów

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Tak

Opis

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

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Zapobieganie
  • Przydział: Nie dotyczy
  • Model interwencyjny: Zadanie dla jednej grupy
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: 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.
Behawioralne: 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.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Change in office systolic blood pressure
Ramy czasowe: Baseline, 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.
Baseline, 8 weeks
Change in office diastolic blood pressure
Ramy czasowe: Baseline, 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.
Baseline, 8 weeks
Change in multidimensional sleep health
Ramy czasowe: Baseline, 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.
Baseline, 8 weeks
Change in sleep duration
Ramy czasowe: Baseline, 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.
Baseline, 8 weeks
Changes in sleep efficiency
Ramy czasowe: Baseline, 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.
Baseline, 8 weeks
Changes in sleep timing
Ramy czasowe: Baseline, 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.
Baseline, 8 weeks
Changes in sleep alertness
Ramy czasowe: Baseline, 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.
Baseline, 8 weeks
Change in sleep satisfaction
Ramy czasowe: Baseline, 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.
Baseline, 8 weeks
Change in subjective sleep quality
Ramy czasowe: Baseline, 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.
Baseline, 8 weeks, 16 weeks
Change in daytime blood pressure (during wake)
Ramy czasowe: 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.
Baseline, 8 weeks
Change in nighttime blood pressure (during sleep)
Ramy czasowe: 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.
Baseline, 8 weeks
Change in mean 24-hour blood pressure
Ramy czasowe: Baseline, 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.
Baseline, 8 weeks
Change in sleep regularity
Ramy czasowe: Baseline, 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.
Baseline, 8 weeks

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Change in body weight
Ramy czasowe: Baseline, 8 weeks
The change in body weight (lbs) from baseline to follow-up at 8 weeks will be calculated.
Baseline, 8 weeks
Change in waist circumference
Ramy czasowe: Baseline, 8 weeks
The change in waist circumference (inches) from baseline to follow-up at 8 weeks will be calculated.
Baseline, 8 weeks
Change in diet quality
Ramy czasowe: Baseline, 8 weeks
The Mediterranean Eating Pattern for Americans (MEPA) scale, which captures adherence to heart healthy dietary pattern, will be used to assess diet quality. The MEPA score ranges from 0-16 with higher scores indicating better diet quality. The change in MEPA scores from baseline to 8 weeks will be calculated.
Baseline, 8 weeks
Change in perceived stress
Ramy czasowe: Baseline, 8 weeks
The Perceived Stress Scale (PSS-10), which helps identify if individuals feel their lives are overloaded, unpredictable, or uncontrollable will be used to measure subjective perception of stress. The PSS-10 scores range from 0-40 with higher scores indicating higher perceived stress. The change in PSS-10 scores from baseline to 8 weeks will be calculated.
Baseline, 8 weeks
Change in anxiety severity
Ramy czasowe: Baseline, 8 weeks
The Generalized Anxiety Disorder-7 (GAD-7) measures anxiety symptom severity over the past two weeks, will be used to screen for generalized anxiety disorder and measure the severity of anxiety. The GAD-7 scores range from 0-21 with higher scores indicating higher levels of anxiety. The change in GAD-7 scores from baseline to 8 weeks will be calculated.
Baseline, 8 weeks
Change in depression severity
Ramy czasowe: Baseline, 8 weeks
The Patient Health Questionnaire-8 (PHQ-8) measures depression symptom severity over the past two weeks, will be used to measure the severity of depression and screen for depressive disorders. The PHQ-8 scores range from 0-24 with higher scores indicating higher depression severity. The change in PHQ-8 scores from baseline to 8 weeks will be calculated.
Baseline, 8 weeks
Change in dyadic coping
Ramy czasowe: Baseline, 8 weeks
The Dyadic Coping Inventory (DCI) is a self-report measure of stress communication and positive and negative forms of dyadic coping. This will be used to assess how couples manage stress together. DCI scores range from 35 to 145, with a higher score indicates higher dyadic coping, and DCI < 111 indicating low dyadic coping. The change in DCI scores from baseline to 8 weeks will be calculated.
Baseline, 8 weeks
Change in dyadic adjustment
Ramy czasowe: Baseline, 8 weeks
The Dyadic Adjustment Scale (DAS) measures relationship quality covering 4 subscales consensus, satisfaction, cohesion, and affectional. This will be used to measure the quality of marriage and similar intimate relationships. The DAS score ranges from 0 to 151, where a higher DAS score indicates better adjustment, and DAS < 98 indicating significant relationship distress/discord. The change in DAS scores from baseline to 8 weeks will be calculated.
Baseline, 8 weeks
Change in self-rated health
Ramy czasowe: Baseline, 8 weeks
Self-rated health will be measured using self-reported health on a Likert scale (excellent, very good, good, fair, poor) where 1 = Excellent and 5 = Poor. The change in self-rated health from baseline to 8 weeks will be calculated.
Baseline, 8 weeks
Acceptability of Intervention
Ramy czasowe: Baseline, 8 weeks
Acceptability will be measured by questionnaire. Items are adapted from the validated Acceptability of Implementation Measure (AIM) and are rated on a 5-point Likert scale ranging from 1 to 5, with 1 indicating "Completely disagree" and 5 indicating "Completely agree." Higher scores indicate better intervention acceptability. The items are analyzed individually and not summed to a total score.
Baseline, 8 weeks
Feasibility of Implementation
Ramy czasowe: Baseline, 8 weeks
Feasibility will be measured by questionnaire using items adapted from the validated Feasibility of Implementation Measure (FIM) and rated on a 5-point Likert scale ranging from 1 to 5, with 1 indicating "Completely disagree" and 5 indicating "Completely agree." Higher scores indicate better feasibility. The items are analyzed individually and not summed to total score.
Baseline, 8 weeks
Appropriateness of Implementation
Ramy czasowe: Baseline, 8 weeks
Appropriateness will be measured by questionnaire. Items are adapted from the validated Implementation Appropriateness Measure (IAM) and are rated on a 5-point Likert scale ranging from 1 to 5, with 1 indicating "Complete disagree" and 5 indicating "Completely agree." Higher scores indicate better appropriateness. The items are analyzed individually and not summed to a total score.
Baseline, 8 weeks
Satisfaction with Intervention
Ramy czasowe: Baseline, 8 weeks
Participants' satisfaction with the study intervention will be assessed using the net promoter score, measured on a scale of 0 to 10. A higher score indicates greater satisfaction.
Baseline, 8 weeks

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Columbia University

Śledczy

  • Główny śledczy: Nour Makarem, PhD, Columbia University

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

8 czerwca 2026

Zakończenie podstawowe (Szacowany)

1 czerwca 2027

Ukończenie studiów (Szacowany)

1 czerwca 2027

Daty rejestracji na studia

Pierwszy przesłany

13 maja 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

18 maja 2026

Pierwszy wysłany (Rzeczywisty)

22 maja 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

1 września 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

31 sierpnia 2026

Ostatnia weryfikacja

1 sierpnia 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Inne numery identyfikacyjne badania

  • AAAW0053

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Opis planu IPD

Data may be shared upon request to PI.

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

Subskrybuj