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Dyadic Sleep Study
RECRUITINGN/ASponsored by University of Miami
Actively Recruiting
PhaseN/A
SponsorUniversity of Miami
Started2024-10-22
Est. completion2026-12-01
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations2 sites
View on ClinicalTrials.gov →
NCT06569693
Summary
The purpose of this study is to learn about sleep behaviors and test different ways to help patients with cancer and caregiver partners.
Eligibility
Age: 18 Years+Healthy volunteers accepted
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.
Conditions2
CancerGastrointestinal Cancer
Locations2 sites
Florida
1 sitePennsylvania
1 siteUniversity of Pittsburgh
Pittsburgh, Pennsylvania, 15260
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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.
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Actively Recruiting
PhaseN/A
SponsorUniversity of Miami
Started2024-10-22
Est. completion2026-12-01
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations2 sites
View on ClinicalTrials.gov →
NCT06569693