Dyadic Sleep Study
University of Miami · with National Institute of Nursing Research (NINR) · NCT06569693
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 18+ · All sexes
- Healthy volunteers
- Accepted
- Study type
- Interventional · Not applicable
- Target enrollment
- 152
- US sites recruiting
- 1
- Study start
- October 22, 2024
- Record last updated
- March 9, 2026
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
The purpose of this study is to learn about sleep behaviors and test different ways to help patients with cancer and caregiver partners.
Being studied: My Sleep Our Sleep (MSOS) Program; Brief Behavioral Treatment for Insomnia (BBTI)
Conditions: Gastrointestinal Cancer
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full criteria
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.
Recruiting US locations
University of Miami
Coral Gables, FL 33146
Site contact: Youngmee Kim, PhD · 305-284-5439 · ykim@miami.edu
Study contacts (from the official record)
- Youngmee Kim, PhD · 305-284-5439 · ykim@miami.edu
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