Field: Mental health and Neuroscience

Location: UQ Centre for Clinical Research (Herston)

Type of student: Both PhD/MPhil and Volunteer

Objectives:

The primary aim of this study is to use n-of-1 trials to improve the precision of clinical decision making in prescribing melatonin for individual adults with Parkinson’s Disease (PD) and insomnia, by identifying individual responders and non-responders to melatonin.

Secondary aims are to: 

1. To aggregate group data from a series of n-of-1 trials to arrive at group estimates of the effectiveness (measured by improvements in Parkinson’s Disease Sleep Scale-2) and safety (measured by adverse events) of melatonin in improving sleep quality in Parkinson’s Disease.

2. To assess feasibility of offering IMET trials for the use of melatonin for insomnia in all suitable people with Parkinson’s Disease.

Methodology:

Each participant will undergo 3 pairs of treatment/placebo. Participants will receive either immediate release melatonin or placebo 30 mins before bedtime. Immediate release melatonin will be sourced from overseas. Two doses will be available (3 mg or 6 mg) in personalised n-of-1 tests. Subjects will undergo a run-in period starting on 3 mg. If this appears effective, they will do the trial on that dose; if not, they will trial 6 mg. For both doses, the comparator will be placebo. 

Using manufacture of matched placebo, the melatonin and placebo will be identical in every way. Patients will keep daily sleep diaries and will wear an actigraph throughout the trial period. After the trial, patients will be unblinded during the process of discussing their results with their doctor based on an individual report provided by trial staff.  Thus the trial will provide direct and immediate feedback to patients about the effectiveness and safety of melatonin for them.

Supervisor

Dr Jane Nikles

Dr Jane Nikles

Senior Research Fellow
UQ Centre for Clinical Research