Double-blind randomised controlled cross-over trial to determine the effect of low dose melatonin on sleep disorders in the elderly

Completed

• Conditions: Dementia; Nervous System Diseases; Dementia in Alzheimer's disease

• Registration Number: ISRCTN14134844
• Lead Sponsor: HS R&D Regional Programme Register - Department of Health (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2004-01-23
• Last Update Posted: 2015-01-13

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 0

Inclusion Criteria

1. Patients aged over 65 years. Either gender.
2. Clinical Diagnostic Statistical Manual, IV edition (DSM-IV). Axix I diagnosis of dementia of Alzheimer's type.
3. Inpatients or patients living at home and managed by carers.

Exclusion Criteria

Does not match inclusion criteria

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. An improvement in patents sleep quality and duration with melatonin compared with placebo. <br>2. An improvement in carers quality of life because if less disruption by restless patients. <br>3. A decrease in need for other more potent medications with significant side effects. <br>The main outcome measure used will be improvement in length of sleep and a decrease in periods of nocturnal wakening for the periods 10 pm and 8 am. <br>Objective measures will be made using a validated sleep activity and pulse logger (Somnitor) (Cole et al 1992).<br>Subsidiary outcome measures will include: recordings of sleep using a sleep diary ratings on quality of sleep using Visual Analogue Scales, carer rating scales and the use of prescribed hypnotic <br>medication.

Secondary Outcome Measures

Name	Time	Method
ot provided at time of registration