InsomniaNCT07926724
SleepCogni: Can the SleepCogni Device (A Handheld Device That Treats Insomnia Using Biofeedback) Improve Sleep in Children With Chronic Insomnia?
A study testing Use of SleepCogni device in people with Insomnia, run by Sheffield Children's NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
Can the SleepCogni device (a handheld device that treats insomnia using biofeedback) improve sleep in children with chronic insomnia? Read more about this study
- Who is it for?
- Ages 6 to 16 years
- Conditions the study is for
- Insomnia
- What is being tested?
- Use of SleepCogni device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 3 Mar 2026to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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 join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
Sheffield Children's Hospital
Sheffield, S10 2TH
Heather Elphick, +441142717400, h.elphick@nhs.net
About this study
Can the SleepCogni device (a handheld device that treats insomnia using biofeedback) improve sleep in children with chronic insomnia?
- Conditions
- Insomnia
- Being tested
- Use of SleepCogni device
- Keywords
- Insomnia
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Use of SleepCogni deviceDevice
Use of SleepCogni device
| Study group | Role | What they receive |
|---|---|---|
| Use of SleepCogni | Experimental | Use of SleepCogni device Receives: Device: Use of SleepCogni device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Questionnaire data
Questionnaire data
Measured: Pre- and post device use (Within 6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2026
- Study start3 Mar 2026
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InsomniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 65 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheffield Children's NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Heather Elphick, Sheffield Children's NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07926724
- Sponsor's protocol ID
- 342316
- Status last verified
- Nov 2026
- First submitted
- 28 Oct 2026
- Last updated
- 9 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SleepCogni: Can the SleepCogni Device (A Handheld Device That Treats Insomnia Using Biofeedback) Improve Sleep in Children With Chronic Insomnia?
- ClinicalTrials.gov ID
- NCT07926724
- Acronym / sponsor ID
- 342316
- Conditions
- Insomnia
- Keywords
- Insomnia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 65 participants (estimated)
- Lead sponsor
- Sheffield Children's NHS Foundation TrustUniversity, hospital or other
- Study start
- 3 Mar 2026 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 9 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Can the SleepCogni device (a handheld device that treats insomnia using biofeedback) improve sleep in children with chronic insomnia?
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Use of SleepCogni | Experimental | Device: Use of SleepCogni deviceUse of SleepCogni device |
Who may qualify
- Ages
- 6 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 6-16 years
- Chronic Insomnia, as defined by ICSD III
- Willingness to engage with the SleepCogni device by both parent and child/young person
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Use of SleepCogni deviceUse of SleepCogni device | Device | Use of SleepCogni |
Primary outcome
Questionnaire data
Time frame: Pre- and post device use (Within 6 months)
Questionnaire data
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Use of SleepCogni device in people with Insomnia, run by Sheffield Children's NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Heather Elphick (+441142717400, h.elphick@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Questionnaire data (time frame: Pre- and post device use (Within 6 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2026.