This study aims to find out whether melatonin can assist people with Parkinson’s Disease to get better sleep.
Melatonin is used to help sleep, but this scientific study will determine whether there is a true effect in individual people with Parkinson’s Disease. By recording individual symptoms in a sleep diary and using a special watch to record sleep patterns, we will be able to identify individual responders and non-responders to melatonin. This will have positive impacts on health and quality of life for both people with Parkinson’s Disease and their family members (especially carers).
Parkinson’s Disease and sleep
Approximately two thirds of people with Parkinson’s Disease experience one or more sleep-related symptoms, with insomnia being the most common. The neurodegenerative process in the brain, disturbances of the sleep-wake cycle, the effect of symptoms of Parkinson’s Disease on sleep, and having another sleep disorder such as restless legs syndrome, all contribute to sleep disturbances in people with Parkinson’s Disease.
Sleep disorders often cause major discomfort in Parkinson’s Disease. Not only is the person’s health and quality of life affected, but so are their family members’, especially if they are also carers. And we have little evidence to suggest that current practices work for long-term treatment of sleep-related problems in people with Parkinson’s Disease. Despite the recognised impact of sleep disturbance in Parkinson’s Disease, there have been few studies in this area.
Melatonin
Melatonin is a hormone released by the pineal gland which regulates the sleep-wake cycle, temperature regulation, reproductive rhythm, and immune function. Melatonin regulates the sleep-wake cycle by promoting the desire to sleep at night. Studies in other conditions show that melatonin can increase sleep efficiency, decrease night-time awakenings, and may be particularly effective to help people get to sleep.
Who is eligible?
To be eligible for this study people must be:
- Aged over 30 years
- Diagnosed with Parkinson’s Disease by a neurologist
- Experiencing sleep difficulties, particularly getting to sleep.
If you are already on melatonin, you can still join the study.
Please note that all patients will require a referral from their doctor (GP or neurologist) to participate.
Why participate?
- You will find out if melatonin helps you by improving your ability to get to sleep, how long you sleep for and the quality of your sleep.
- At the end of your time on the study, a detailed and individual report about whether the melatonin worked for you will be given to your doctor to discuss with you.
- You will help others by assisting us to determine if melatonin should be included in treatment plans for people with Parkinson’s Disease who are having trouble sleeping.
What do I need to do?
This study involves two phases:
- Phase 1 involves answering a questionnaire, education about treatment, and recording sleeping patterns in a sleep diary for two weeks.
- Phase 2 involves testing medication effectiveness for 12 weeks. During this period, you will be given both melatonin or a placebo, in blocks of two weeks each, and in a random order. You will also need to keep a sleep diary and complete some questionnaires.
Our research has full ethics approval.
Who is conducting the study?
This study brings together a team of researchers from The University of Queensland, Wesley Medical Research and St Andrew’s War Memorial Hospital. We hope that our research will help patients, families and medical practitioners to find a better treatment for long-term sleeping difficulties among people with Parkinson’s Disease.
Contact
Register to join the study here: https://clinical-research.centre.uq.edu.au/research/brain-and-mental-health/n-1-trials-and-sleep-research/melatonin-insomnia-parkinsons-disease
General email: insompd@uq.edu.au (Please send your contact mobile number and/or landline number and your address to guarantee that we can contact you)
Study Team contacts
Dr Jane Nikles: uqjnikle@uq.edu.au, Mob 0408 599 033
Office phone: 07 3346 5065 or 07 3346 5025
