Melatonin treatment for sleep problems in children with autism: a randomised controlled crossover trial
| ISRCTN | ISRCTN77884120 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN77884120 |
| Secondary identifying numbers | N/A |
- Submission date
- 23/04/2008
- Registration date
- 19/06/2008
- Last edited
- 27/03/2012
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English Summary
Not provided at time of registration
Contact information
Dr Barry Wright
Scientific
Scientific
Lime Trees Child
Adolescent & Family Unit
31 Shipton Road
York
YO30 5RF
United Kingdom
| Phone | +44 (0)1904 726610 |
|---|---|
| barry.wright@nyypct.nhs.uk |
Study information
| Study design | Randomised controlled crossover trial. |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | |
| Study hypothesis | Melatonin will be better than placebo at improving time-to-onset of sleep (sleep latency) and total sleep time. |
| Ethics approval(s) | York Research Ethics Committee. Date of Approval: 21/01/2004 (ref: 03/12/17) |
| Condition | Sleep disorder in autism |
| Intervention | This is a crossover trial, with two arms: Melatonin medication vs placebo. Group 1: One month no medication, 3 months melatonin, 1 month washout, 3 months placebo, 1 month no medication. Group 2: One month no medication, 3 months placebo, 1 month washout, 3 months melatonin, 1 month no medication. Melatonin (oral) started at 2 mg 30-40 minutes before planned sleep and increased every 3 nights by 2 mg to a maximum dose of 10 mg, titrating the dose to the response. If good sleep is achieved, the dose is kept at that level. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Melatonin |
| Primary outcome measure | The following are recorded by the family every day from the beginning of the study for 9 months: 1. Sleep latency (i.e. time to onset of sleep) 2. Number of hours sleep per night (as recorded in daily sleep diaries) |
| Secondary outcome measures | The following are carried out at baseline and after 4, 8 and 9 months: 1. General Health Questionnaire 2. Sleep Difficulties Questionnaire (Likert scale) |
| Overall study start date | 01/04/2004 |
| Overall study end date | 01/11/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 4 Years |
| Upper age limit | 10 Years |
| Sex | Not Specified |
| Target number of participants | 32 |
| Participant inclusion criteria | 1. Both male and female children, aged 4-10 years 2. Diagnosis of typical or atypical childhood autism and sleep disorder (as defined by World Health Organization ICD-10 and sub-classified using the International Classification of Sleep Disorders) |
| Participant exclusion criteria | 1. Children on any other medication including anti-epileptic medication 2. Children previously on melatonin or having any other sleep disorder treatments 3. Any families who do not complete sleep diaries during the one month lead-in period |
| Recruitment start date | 01/04/2004 |
| Recruitment end date | 01/11/2008 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Lime Trees Child
York
YO30 5RF
United Kingdom
YO30 5RF
United Kingdom
Sponsor information
North Yorkshire and York Primary Care Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
c/o North Yorkshire Alliance R&D Unit
Learning & Research Centre
York District Hospital
Wigginton Road
York
YO31 8HE
England
United Kingdom
| Phone | +44 (0)1904 726996 |
|---|---|
| research.governance@york.nhs.uk | |
| Website | http://www.nyypct.nhs.uk |
Funders
Funder type
Government
York Innovation Research Fund from the York and Selby Research and Development Committee, Selby and York Primary Care Trust. The Committee is currently represented by the North Yorkshire Research and Development Alliance (http://www.northyorksresearch.nhs.uk) (UK)
No information available
London Law Trust (UK) (ref: 10/1/04)
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 | 01/02/2011 | Yes | No |
