SleepCogni: Can the SleepCogni Device (A Handheld Device That Treats Insomnia Using Biofeedback) Improve Sleep in Children With Chronic Insomnia?

What this study involves

The registry says this study is recruiting. Individual locations may have different availability.

Study type

Interventional

Phase

Not applicable

Age range

6 years - 16 years

Sex eligible

All sexes

Healthy volunteers

Not accepted

Participants

65 Estimated

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

Can the SleepCogni device (a handheld device that treats insomnia using biofeedback) improve sleep in children with chronic insomnia?

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

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

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment

Not applicable

Masking

No masking

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

Research locations (1)

The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.

1 locations

Study team and timeline

Lead sponsor

Sheffield Children's NHS Foundation Trust

Study start

Mar 3, 2026 Actual

Primary completion

Dec 31, 2027 Estimated

Study completion

Dec 31, 2027 Estimated

First posted

Nov 9, 2026 Actual

Last updated

Nov 9, 2026 Actual

Official study contacts