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Protocol MelatoSom-Kids-PTSD: sleep disturbances in children and adolescents with post-traumatic stress disorder (PTSD) — a randomized double-blind placebo-controlled trial to investigate the efficacy of paediatric prolonged-release melatonin

Understanding the MelatoSOM-Kids-PTSD Study

Introduction

Children and adolescents suffering from post-traumatic stress disorder (PTSD) often experience sleep problems like insomnia and nightmares. These sleep issues can greatly affect their daily lives and mental health, as well as the wellbeing of their families. Although many kids with PTSD struggle with sleep, there isn’t a specific treatment for these disturbances. This study explores a treatment using prolonged-release melatonin, which may help improve sleep for these young patients.

About the Study

The MelatoSOM-Kids-PTSD study is a significant trial aiming to test if prolonged-release melatonin can effectively alleviate sleep troubles in children and adolescents with PTSD. The study will involve:

  • 120 participants recruited over 24 months.
  • A double-blind setup where one group receives melatonin and the other a placebo (inactive treatment).
  • A 13-week treatment period.

Goals of the Study

The main goal is to compare the total sleep time between the melatonin group and the placebo group after 13 weeks. Secondary goals include examining overall sleep quality and daytime functioning improvements for both children and their caregivers.

Measurable Outcomes

The study will focus on clear and measurable outcomes, such as:

  • Changes in sleep duration.
  • Improvements in sleep quality.
  • Enhanced daytime activities for children with PTSD.

AI Tools for Clinical Needs

To support the success of this study, AI solutions can be selected to help with specific clinical needs. This includes data analysis and tracking treatment outcomes to ensure the most effective use of the findings.

Implementation Steps

We recommend starting with a pilot project to test the treatment and track results through the use of AI tools. This will help assess the real-world impact of using prolonged-release melatonin in treating sleep disturbances in children with PTSD.

Contact Us for More Information

If you’re interested in AI solutions in medical management related to this study, please reach out to us:

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