Melatonin and Sleep in Preventing Delirium in the Hospital (MELO)

Scripps Health

Status and phase: Completed; Phase 2; Phase 1

Conditions: Delirium

Treatments: Dietary Supplement: Melatonin; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02597231

IRB-15-6639

Details and patient eligibility

About

Recent data suggests that melatonin, a supplement available over the counter, may help prevent delirium in hospitalized patients. The investigators are hypothesizing that melatonin may help in delirium prevention by improving sleep quality and possibly circadian rhythm cycling in patients who are given the supplement. This pilot study involves a randomized placebo-controlled design in which participants will be randomized to receive either melatonin 3mg orally or placebo orally. Participants in both groups will be fitted with wireless actigraphy devices to obtain objective sleep quality, and will also receive a sleep questionnaire each morning to obtain subjective data on their sleep quality overnight. Delirium will be assessed by floor nurses twice daily using the Confusion Assessment Method (CAM).

Enrollment: 94 patients

Sex: All

Ages: 65 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 65-100 years old
• Admitted to Scripps Green Hospital
• Admitted to an Internal Medicine or Medicine Consult Service
• Expected to have a hospital stay of greater than or equal to 48 hours (patients admitted to "inpatient," not "observation," under Medicare guidelines)

Exclusion criteria

• Cirrhosis of any etiology
• Admitted for alcohol withdrawal
• Currently taking a 1st or 2nd generation anti-psychotic
• Active delirium (i.e., delirium prior to 1st dose of melatonin)
• Diagnosis of encephalitis
• History of seizure

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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94 participants in 2 patient groups, including a placebo group

Melatonin Group

Experimental group

Description:

Patients in this group will receive melatonin 3mg orally at 9pm.

Treatment:

Dietary Supplement: Melatonin

Placebo Group

Placebo Comparator group

Description:

Patient in this group will receive a matching placebo pill orally at 9pm.

Treatment:

Other: Placebo