Testing melatonin for treating hypoactive delirium in older adults
Better Outcome With Melatonin Compared to Placebo Administered to Normalize Sleep-wake Cycle and Treat Hypoactive ICU Delirium The Basel BOMP-AID Randomized Trial
This study is testing if melatonin can help older adults with hypoactive delirium feel better.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 190 (estimated) |
| Ages | 55 Years and up |
| Sex | All |
| Sponsor | University Hospital, Basel, Switzerland Academic / other |
| Locations | 1 site (Basel) |
| Trial ID | NCT03438526 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of melatonin in treating hypoactive delirium in adult patients aged 55 and older who are currently experiencing this condition. The study utilizes a randomized, controlled design, comparing melatonin to a placebo to assess improvements in delirium symptoms. The trial aims to address the lack of pharmacological treatment options for hypoactive delirium, which is often overlooked despite its prevalence and serious consequences. Participants will be evaluated using specialized assessment methods to confirm their eligibility based on specific delirium criteria.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 55 years or older who are currently experiencing hypoactive delirium.
Not a fit: Patients who have a history of delirium prior to ICU admission or those with conditions such as dementia or active psychosis may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new treatment option for hypoactive delirium, potentially improving patient outcomes and quality of life.
How similar studies have performed: While many studies have focused on hyperactive and mixed delirium, this approach to treating hypoactive delirium with melatonin is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Participants fulfilling all of the following inclusion criteria are eligible for the study: * Adult patients (aged 55 years or older) * Current delirium (hypoactive type) detected by a specialised assessment method: ICDSC score \>2 and RASS score \< 0 Exclusion Criteria: Participants meeting the following criteria are excluded from the study: * Delirium prior to ICU admission * Sleep disorder not caused by hypoactive delirium * Sedation in the ICU * Hypersensitivity to the studied substances (i.e., melatonin, placebo content) * Age \<55 years * Terminal state * Status epilepticus or postictal states following seizures on electroencephalogram (EEG) * Active psychosis * Substance abuse in current medical history * Dementia * Pregnancy
Where this trial is running
Basel
- University Hospital Basel — Basel, Switzerland (Recruiting)
Study contacts
- Principal investigator: Alexa Hollinger, MD — University Hospital, Basel, Switzerland
- Study coordinator: Alexa Hollinger, MD
- Email: alexa.hollinger@usb.ch
- Phone: +41786747130
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.