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

ISRCTN	ISRCTN14134844
DOI	https://doi.org/10.1186/ISRCTN14134844
Protocol serial number	RDC00970
Sponsor	NHS R&D Regional Programme Register - Department of Health (UK)
Funder	NHS Executive London (UK)

Submission date: 23/01/2004
Registration date: 23/01/2004
Last edited: 11/01/2010

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nervous System Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Marc Serfaty
Scientific

Royal Free Hospital School of Medicine
University Department of Psychiatry
Rowland Hill Street
London
NW3 2PF
United Kingdom

Phone	+44 (0)20 7830 2293/7794 0500

Study information

Primary study design	Interventional
Study design	Randomised placebo controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	There has recently been a considerable growth of interest in the therapeutic potential of the pineal hormone melatonin. Exogenous low-dose melatonin has been shown to be a safe and effective treatment of conditions where there is a disturbance of the sleep-wake cycle. In elderly subjects without mental illness, melatonin is effective in treating sleep disturbance. Disruption of sleep is especially common with reversal of the sleep-wake cycle. Not only does disruption of the sleep pattern cause considerable distress to patients, it is also one of the major problems encountered by carers. Indeed, a breakdown of care by relatives has significant economic implications. Since dementia is also associated with disturbance of circadian rhythm and exogenous melatonin is effective in entraining the sleep cycle in normal subjects, we propose a trial to test the hypothesis that exogenous low dose melatonin will improve sleep in elderly subjects with dementia.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Dementia
Intervention	1. Low dose melatonin 2. Placebo
Intervention type	Other
Primary outcome measure(s)	1. An improvement in patents sleep quality and duration with melatonin compared with placebo. 2. An improvement in carers quality of life because if less disruption by restless patients. 3. A decrease in need for other more potent medications with significant side effects. 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. Objective measures will be made using a validated sleep activity and pulse logger (Somnitor) (Cole et al 1992). 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 medication.
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	03/09/2000

Eligibility

Participant type(s)	Patient
Age group	Senior
Sex	All
Key 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.
Key exclusion criteria	Does not match inclusion criteria
Date of first enrolment	03/08/1998
Date of final enrolment	03/09/2000

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Royal Free Hospital School of Medicine

London
NW3 2PF
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/12/2002		Yes	No