SleepCogni for children with chronic insomnia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study uses a handheld SleepCogni device that delivers biofeedback to assess whether it can improve sleep in children with chronic insomnia. Participants and their parents use the device, providing data on sleep outcomes over the trial period. The trial focuses on feasibility and potential sleep improvements in pediatric patients who can engage with behavioral strategies and the device. No control group or randomization details are provided in the available information. Safety monitoring and data collection are aligned with standard clinical trial practices.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 6-16 years
* Chronic Insomnia, as defined by ICSD III
* Willingness to engage with the SleepCogni device by both parent and child/young person

Exclusion Criteria:

* Primary sleep problem is physiological, eg sleep disordered breathing
* Insufficient understanding of English language,
* Severe presentation, eg non-verbal, learning difficulties which mean child is unable to understand the purpose of the device.
* Children/parents already known to be unable to engage with behavioural strategies

Where it's running

• Sheffield Children's Hospital
  Sheffield, United Kingdom Recruiting

Study contacts

• Study coordinator: Heather Elphick
• Email: h.elphick@nhs.net
• Phone: +441142717400

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.