`CRITIQUE PLAN 2
Slide 1: Explaining study
The study I have chosen is a study designed to assess the effectiveness and safety of using melatonin in treating severe sleep problems in children with neurodevelopmental disorders. Melatonin is a hormone that naturally occurs in animals, plants and microbes, and has a variety of different functions. In animals one function is that it serves as a trigger for a seasonal clock. In humans it is produced by the pineal gland, and it creates a signal that induces drowsiness and low body temperature, helping prepare the body for sleep after the body detects that it is night time. In the United States melatonin supplements are readily available over the counter to help people who suffer from insomnia and other sleep disorders, but in the United Kingdom this is not the case as there is not enough research to support the use of melatonin. This study used 146 children ages 3 to 15 years 8 months who all had a range of neurodevelopmental disorders accompanied by issues with their sleeping that had not been able to be sorted by a standard advice booklet given to their parents 6 weeks before they were randomised. The design of the trial was a 12 week double masked randomised placebo controlled phase III trial, which basically meant that neither the people running the study nor the participants knew whether or not they had taken the melatonin or a placebo which was being used as the control, and the participants were randomised so that it was up to chance whether or not they received the placebo or the melatonin. The fact that the trial is Phase 3 means that there have been 3 levels of testing beforehand to assess the safety of the drug before this study could be performed on a larger group of participants.
Slide 2: Explaining study
The interventions within the study were that an immediate release melatonin or matching placebo capsule was administered 45 minutes before the child’s bedtime over the 12 weeks. The children started by taking 0.5mg capsules, and then the dose was increased through 2mg, 6mg and 12mg depending on their response to the hormone. The child’s total time spent asleep after 12 weeks was then adjusted for baseline, recorded in sleep diaries completed by the parents. The assessment of the child’s behaviour, family functioning and adverse events were also included as secondary outcomes, and the sleep was measured using diaries and actigraphy, which is the monitoring of movement whilst resting, and is a good quantitative indicator of whether a patient is asleep or not. The results of the study were that sleep time increased by a total of 22.4 minutes with 95% confidence when measured by sleep diaries, and 13.3 minutes when measured by actigraphy. However, melatonin was associated with earlier waking times than the placebo. The child’s behaviour and family functioning outcome showed a little improvement and favoured the use of melatonin, and adverse events were mild and similar…