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Completed
NCT07417163
LiverSleep: A Behavioral Sleep Intervention for Patients With Cirrhosis and Insomnia
Conditions: Cirrhosis, Insomnia
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 11
Sponsor: Massachusetts General Hospital
Location: Massachusetts General Hospital Boston Massachusetts
Summary
This is a pilot trial to test the feasibility and acceptability of a virtual cognitive behavioral program for insomnia for patients with cirrhosis.
Eligibility Criteria
Inclusion Criteria:
1. Adult (≥ 18 years) patients with cirrhosis (either compensated or decompensated) receiving ambulatory care at the MGH Liver Clinic or MGH Liver Transplant Evaluation Clinic
2. Have the ability to communicate in English
3. Have at least mild insomnia (ISI score ≥8) and report sleep difficulty, defined as ≥ 30 min to fall asleep or spending at least 30 min awake during the night
Exclusion Criteria:
1. Uncontrolled neuropsychiatric disorders such as severe depression, schizophrenia, or suicidal ideation which prohibits their ability to provide informed consent.
2. Cognitive impairment, which we will screen for using the simplified Animal Naming Test
3. Current alcohol misuse
4. Diagnosis of obstructive sleep apnea that is untreated or high-risk for obstructive sleep apnea
5. Severe restless leg syndrome
6. Those with night/rotating shift work
Source: ClinicalTrials.gov (NCT07417163). StuddyBuddy aggregates publicly available trial information.