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RecruitingNCT07926724Updated Nov 9, 2026

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

An interventional study of Use of SleepCogni device in Insomnia, sponsored by Sheffield Children's NHS Foundation Trust. Recruiting at 1 site in United Kingdom. Open to participants aged 6 Years to 16 Years. Per ClinicalTrials.gov, last updated 2026-11-09.

Sponsored by Sheffield Children's NHS Foundation Trust · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 7 months after the study started (first participant enrolled Mar 2026, registered Oct 2026).
  • Started Mar 2026; still recruiting 8 months later.
Updated Nov 9, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
65
Allocation
Not applicable
Ages
6 Years to 16 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Insomnia

Keywords

  • Insomnia
03

In context

Sleep Initiation and Maintenance Disorders

2,722 studies on the registry are indexed under Sleep Initiation and Maintenance Disorders; 726 are open to participants now.

This study's planned enrollment of 65 is close to the median of 68 across 2,350 interventional studies indexed under Sleep Initiation and Maintenance Disorders.

Browse Sleep Initiation and Maintenance Disorders studies →

Lead sponsor

Sheffield Children's NHS Foundation Trust is the lead sponsor of 53 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Years to 16 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
65 participants (estimated)

Study arms

  • Experimental
    Use of SleepCogni

    Use of SleepCogni device

    Device: Use of SleepCogni device

Interventions

  • DeviceUse of SleepCogni device

    Use of SleepCogni device

06

What researchers measure

Primary outcomes

  1. Questionnaire data

    Questionnaire data

    Time frame: Pre- and post device use (Within 6 months)

07

Study locations

1 of 1 sites recruiting
08

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: Undecided

09

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Nov 9, 2026
Show all 1 update
  1. Nov 9, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07926724
Lead sponsor
Sheffield Children's NHS Foundation Trust
Responsible party
Heather Elphick (Consultant in Respiratory & Sleep Medicine, Sheffield Children's NHS Foundation Trust) — Principal investigator
First posted
Nov 9, 2026
Start date
Mar 3, 2026
Primary completion
Dec 31, 2027 (estimated)
Completion
Dec 31, 2027 (estimated)
Last update
Nov 9, 2026

Study contacts

Heather Elphick
Contact
h.elphick@nhs.net
+441142717400

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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