Handheld biofeedback device for children with long-term insomnia
Tests the SleepCogni handheld device for sleep in children with chronic insomnia.
Key facts
- Who runs it
- Sheffield Children's NHS Foundation Trust
- Where
- Sheffield, United KingdomSee the site
- Trial code
- Registry title
- SleepCogni: Can the SleepCogni Device (A Handheld Device That Treats Insomnia Using Biofeedback) Improve Sleep in Children With Chronic Insomnia?
- Status
- Recruiting
- People taking part
- 65 people, planned
- Started
- 3 Mar 2026
- Expected to end
- 31 Dec 2027
- Type of study
- Interventional
- Treatments tested
- Use of SleepCogni device
- Record updated
- 9 November 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for children and young people aged 6-16 years with long-term (chronic) insomnia. They will use the SleepCogni handheld device, which uses biofeedback.
- Age
- 6-16 years
- Sex
- All sexes
- Disease stage
- Chronic insomnia, as defined by ICSD III (a standard sleep disorder classification).
Main reasons for not taking part
- The main sleep problem has a physical cause, for example breathing problems during sleep
- Not enough understanding of the English language
- Severe needs, for example non-verbal or learning difficulties, so the child cannot understand what the device is for
- Child or parents already known to be unable to follow behaviour-based strategies
- Parent and child not willing to use the SleepCogni device
The registry criteria, word for word
Show all 7 criteriaShow less
Who can take part
- 6-16 years
- Chronic Insomnia, as defined by ICSD III
- Willingness to engage with the SleepCogni device by both parent and child/young person
Who cannot take part
- 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
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 6 and 16 years old?
Where in United Kingdom
- Sheffield Children's HospitalSheffield, United KingdomContact: Heather ElphickTaking people
About the trial
What the trial wants to find out
Can the SleepCogni device (a handheld device that treats insomnia using biofeedback) improve sleep in children with chronic insomnia?
The group in the trial
- Use of SleepCogniTreatment being tested
Use of SleepCogni device
Treatment: Use of SleepCogni device
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- SleepCogni: Can the SleepCogni Device (A Handheld Device That Treats Insomnia Using Biofeedback) Improve Sleep in Children With Chronic Insomnia?
- Plain-language title
- Handheld biofeedback device for children with long-term insomniaGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 14 November 2026.
- Fit questions
- Built from NCT07926724, who can take part
- Record updated
- 9 November 2026