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 |
| Secondary identifying numbers | RDC00970 |
- 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
Not provided at time of registration
Contact information
Dr Marc Serfaty
Scientific
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
| Study design | Randomised placebo controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | |
| Study hypothesis | 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 |
| Condition | Dementia |
| Intervention | 1. Low dose melatonin 2. Placebo |
| Intervention type | Other |
| Primary outcome measure | 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. |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 03/08/1998 |
| Overall study end date | 03/09/2000 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | Both |
| Target number of participants | Not provided at time of registration |
| Participant 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. |
| Participant exclusion criteria | Does not match inclusion criteria |
| Recruitment start date | 03/08/1998 |
| Recruitment end date | 03/09/2000 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Royal Free Hospital School of Medicine
London
NW3 2PF
United Kingdom
NW3 2PF
United Kingdom
Sponsor information
NHS R&D Regional Programme Register - Department of Health (UK)
Government
Government
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Phone | +44 (0)20 7307 2622 |
|---|---|
| dhmail@doh.gsi.org.uk | |
| Website | http://www.doh.gov.uk |
Funders
Funder type
Government
NHS Executive London (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
