Paediatric Insomnia
Supporting better sleep for children (aged 2-17)
If your child struggles to fall asleep or stay asleep, you are not alone. Sleep difficulties can be exhausting, worrying, and emotionally draining for the whole family.
At Promed Innovations, we understand how deeply sleep affects a child’s wellbeing and a parent’s peace of mind. This research study has been designed with care, sensitivity, and respect for families who are navigating ongoing sleep challenges. Our priority is always your child’s comfort, and safety.
About the Study
This study is exploring a medicine called tasimelteon to better understand whether it may help improve night-time sleep in children and adolescents with insomnia.
Tasimelteon is already approved in the UK, Europe, and the United States for certain sleep-related conditions in adults.
The study aims to:
- Better understand sleep patterns in children with insomnia
- Explore whether tasimelteon may help reduce the time it takes for children to fall asleep
- Support the development of future insomnia treatment options for families
Who Can Take Part
Children and young people may be considered for the study if they:
- Are aged 2 to 17 years
- Have ongoing difficulty falling asleep, several nights each week
- Have experienced difficulties for several months
Every child’s situation is carefully reviewed during a screening process. This helps ensure that participation is appropriate and safe for each child.
What Participation Involves
Participation lasts around 13 months and includes up to five visits to the study site. Families can expect:
- A screening period to understand your child’s sleep before treatment
- During the treatment phase, children are randomly assigned to receive either tasimelteon or a placebo (a look‑alike medicine with no active ingredient).
- An open‑label phase where all continuing participants will receive tasimelteon.
Most daily activities happen at home, including taking the study medicine, completing short sleep diaries, and wearing a wrist activity watch. Parents will remain involved throughout.
Additional Information
Your child’s safety is our highest priority.
- The study has ethical approval and regulatory oversight in the UK
- Children are closely monitored by experienced healthcare professionals
- Parents give informed consent, and children are involved in age-appropriate discussions
- You may withdraw your child at any time, without affecting their medical care
All personal information is kept confidential and handled in line with UK data protection laws.
Registered Company Name: PROMED INNOVATIONS
Registered Company Number: 14926187
Member of the society for clinical research sites
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