Nervous System Diseases: Sleep disorders Nervous System Diseases Sleep disorders
Conditions
Interventions
Melatonin versus placebo.
Sponsors
Record provided by the NHS Trusts Clinical Trials Register - Department of Health (UK)
Eligibility
Inclusion criteria
Inclusion criteria: Patients admitted to the adult general intensive care unit with acute respiratory failure requiring mechanical ventilation and then a tracheostomy to assist weaning.
Exclusion criteria
Exclusion criteria: 1. Expected length of stay of less than five further days 2. Previously treated for sleep disturbances 3. Not receiving target enteral feed volume or aspirates greater than 200mls 4. Previous history of convulsions 5. Psychiatric or neurological disease 6. Excessive alcohol consumption (equal to or greater than 50 units per week) 7. Recreational drug use 8. Sleep apnoea 9. Severe heart failure (NYHA III/ IV) 10. Sedative infusions must have been discontinued for more than 24 hours (propofol and alfentanil) or more than 36 hours (morphine and midazolam) with a Sedation Agitation Score (SAS) > 3
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sleep and delirium. | — |
Secondary
| Measure | Time frame |
|---|---|
| No secondary outcome measures | — |
Countries
United Kingdom
Outcome results
None listed