Actively Recruiting
Led by University Hospital, Basel, Switzerland · Updated on 2024-12-11
190
Participants Needed
1
Research Sites
52 weeks
Total Duration
Delirium is a brain-related condition that often develops after surgery or during an ICU stay, especially in older adults. It can lead to serious complications like longer hospital stays, reduced quality of life, and higher risk of death. This trial focuses on hypoactive delirium, a subtype where patients are calm or sleepy but hard to detect and currently lack effective drug treatments. Researchers aim to study whether melatonin can help restore the normal sleep-wake cycle and reduce delirium duration and severity compared to placebo. In this randomized study, patients aged 55 or older diagnosed with hypoactive delirium will receive either 4 mg of oral melatonin or a placebo each night at 8 p.m. The treatment may be repeated nightly until delirium resolves. Standard care for hypoactive delirium will continue during the day, and if mixed delirium appears, additional medications like haloperidol may be used. The study will compare how long delirium lasts and whether melatonin reduces progression to more agitated forms. Participants will be closely monitored using daily assessments and smartwatches to track sleep patterns, activity, and skin temperature. Researchers will evaluate delirium duration, number of delirium-free days, survival up to one year, ventilator use, ICU and hospital stay lengths, and sleep quality. Follow-up at three and twelve months after hospital discharge will collect information on health, readmissions, daily living activities, and any further delirium episodes. The total study period for each patient is up to 28 days, with long-term follow-up extending to one year after ICU admission.
CONDITIONS
The Basel BOMP-AID Randomized Trial
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Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Duration - Up to 28 days or until delirium resolution
Participants receive nightly oral melatonin or placebo at 8 p.m. to treat hypoactive delirium until the delirium resolves.
Daily administration at night
Duration - Up to 12 months after hospital discharge
Participants are followed up at three and twelve months after hospital discharge to assess long-term outcomes including survival, hospital readmission, activities of daily living, and additional episodes of delirium.
2 follow-up contacts (at 3 and 12 months post-discharge)
Total: 1 location
1
University Hospital Basel
Basel, Switzerland, 4031
Actively Recruiting
A
Alexa Hollinger, MD
M
Martin Siegemund, MD
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Alexa Hollinger, Stefanie von Felten, Raoul Sutter...
https://pubmed.ncbi.nlm.nih.gov/32354780