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Recruiting
NCT07926724
SleepCogni: Can the SleepCogni Device (A Handheld Device That Treats Insomnia Using Biofeedback) Improve Sleep in Children With Chronic Insomnia?
Conditions: Insomnia
Sex: All
Ages: 6 Years – 16 Years
Healthy volunteers: No
Phase: NA
Enrollment: 65
Sponsor: Sheffield Children's NHS Foundation Trust
Location: Sheffield Children's Hospital Sheffield
Summary
Can the SleepCogni device (a handheld device that treats insomnia using biofeedback) improve sleep in children with chronic insomnia?
Eligibility Criteria
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
Source: ClinicalTrials.gov (NCT07926724). StuddyBuddy aggregates publicly available trial information.