Dyadic Sleep Study

March 6, 2026 updated by: Youngmee Kim, University of Miami
The purpose of this study is to learn about sleep behaviors and test different ways to help patients with cancer and caregiver partners.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

152

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Youngmee Kim, PhD
  • Phone Number: 305-284-5439
  • Email: ykim@miami.edu

Study Locations

  • United States
    • Florida
      • Coral Gables, Florida, United States, 33146
        • Recruiting
        • University of Miami
        • Contact:
        • Principal Investigator:
          • Youngmee Kim, PhD
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15260
        • Active, not recruiting
        • University of Pittsburgh

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • The eligibility criteria for patients are:

    • newly diagnosed with stage I to IV of a GI cancer (anus, colon, esophagus, gallbladder, large and small intestine, liver, pancreas, rectum, stomach, other biliary or digestive organs)
    • diagnosis in the past 72 months at the time of enrollment
    • having a consistent sleep partner.

  • The eligibility criterion for caregivers is:

    • a sleep partner of the patient or partner who wish to resume sleeping together with the patient

  • Additional eligibility criteria for both patients and caregivers are:

    • Pittsburgh Sleep Quality Index (PSQI) ≥ 5,
    • willing to change sub-optimal sleep habits,
    • 18 years or older,
    • able to speak/listen English at the 8th grade level for intervention sessions,
    • able to read English or Spanish at the 8th grade for self-reported questionnaires,
    • > 4 weeks after surgery, if any, prior to enrollment, and no surgery planned in the next 5 weeks during the study period because surgery affects sleep.

Exclusion Criteria:

  • Exclusion criteria for both patients and caregivers are having had a diagnosis of major depressive disorder, psychosis, or bipolar disorder that is not currently treated;
  • Active suicidality, or substance or alcohol dependency in the past year;
  • Currently have narcolepsy, restless leg syndrome, or untreated sleep apnea that is screened using the Sleep Health Screen;
  • Both patients and caregivers have an extreme chronotype, or do shift work to have no overlap in sleep schedule between them; and plan trans-meridian travel during the period of data collection blocks; and having hearing or visual impairment, dementia, or cognitive dysfunction.
  • Adults unable to consent, individuals who are not yet adults, pregnant women, or prisoners will be excluded.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MSOS Intervention Group
Participants (patient-sleep-partner caregiver dyads) in this group will receive the My Sleep Our Sleep (MSOS) intervention. Total participation is up to 13 weeks.
Behavioral: My Sleep Our Sleep (MSOS) Program

MSOS is a sleep intervention developed by the investigator aimed at improving sleep health for patient-sleep-partner caregiver dyads using behavioral education in sleep behaviors, sleep cognition and sleep in relationship.

MSOS will be delivered over four weeks, in weekly one-hour sessions, one session per week.

Other Names:
  • MSOS
Experimental: BBTI Intervention Group
Participants (patient-sleep-partner caregiver dyads) in this group will receive the Brief Behavioral Treatment for Insomnia (BBTI). Total participation is up to 13 weeks.
Behavioral: Brief Behavioral Treatment for Insomnia (BBTI)

BBTI is brief patient-focused intervention for patient-sleep-partner caregiver dyads, aimed at altering participants' sleep behaviors to improve sleep. BBTI utilizes behavioral education in sleep restriction and stimulus control. For sleep restriction, participants will be instructed to limit the time they spend in bed, which serves to increase sleep efficiency. For stimulus control, participants will be instructed to go to bed only when feeling sleepy and reserve the bed for sleep and intimacy.

BBTI will be delivered over four weeks, in weekly one-hour sessions, one session per week.

Other Names:
  • BBTI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in sleep disturbance symptoms as measured by scores on the Pittsburgh Sleep Quality Index (PSQI)
Time Frame: Baseline, Up to 13 weeks
Change in sleep disturbance symptoms (patient-sleep-partner caregiver dyads) among participants will be compared and reported for both intervention groups, BBTI and MSOS, as measured by scores on the Pittsburgh Sleep Quality Index (PSQI). The PSQI is a self-reported, 19-item questionnaire health-related quality of life (HRQOL) questionnaire which assesses sleep quality and disturbances at baseline, week 5 and week 13. Questions generate seven "component" scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. The sum of scores for these seven components yields one global score. A decrease of ≥ 5 points on the PSQI) will be considered as clinical improvement of symptoms.
Baseline, Up to 13 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in insomnia symptoms as measured by scores on the Insomnia Severity Index (ISI)
Time Frame: Baseline, Up to 13 weeks
Change in insomnia symptoms among participants (patient-sleep-partner caregiver dyads) will be compared and reported for both intervention groups, BBTI and MSOS, as measured by scores on the 7-item Insomnia Severity Index (ISI). The ISI is a self-reported, health-related quality of life (HRQOL) questionnaire used to assess insomnia symptoms at baseline, week 5 and week 13. The dimensions evaluated are: severity of sleep onset, sleep maintenance, and early morning awakening problems, sleep dissatisfaction, interference of sleep difficulties with daytime functioning, notice ability of sleep problems by others, and distress caused by the sleep difficulties. A 5-point Likert scale is used to rate each item, ranging from 0 to 4 (e.g., 0 = no problem; 4 = very severe problem). The total score ranges from 0 to 28, the lower total score indicates a lower level of insomnia. Greater than a 6-point decrease on the ISI is considered substantial reduction in insomnia symptoms.
Baseline, Up to 13 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Miami

Collaborators

National Institute of Nursing Research (NINR)

Investigators

  • Principal Investigator: Youngmee Kim, PhD, University of Miami

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 22, 2024

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

August 22, 2024

First Submitted That Met QC Criteria

August 22, 2024

First Posted (Actual)

August 26, 2024

Study Record Updates

Last Update Posted (Actual)

March 9, 2026

Last Update Submitted That Met QC Criteria

March 6, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20240214
  • R21NR021083 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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