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Somfit - Paediatric forehead wireless monitoring device for sleep analysis

Evaluating the sleep staging capability of the Somfit Paediatric forehead wireless monitoring device in children

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12626000710325
Enrollment
20
Registered
2026-06-15
Start date
2026-07-01
Completion date
2026-12-31
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This prospective pilot study aims to evaluate the sleep staging and sleep apnoea detection capability of the Somfit device in children. Twenty children will undergo simultaneous in-hospital polysomnography and Somfit overnight sleep assessment. Children less than four years of age will be excluded. Additionally, patient/parent feedback will be sought. This is a single centre study.

Interventions

Application of Somfit wireless forehead sleep monitoring device by trained paediatric sleep scientists during in-hospital polysomnography being conducted over a single night (minimun 6 hours, maximum 14 hours) as part of usual care. Somfit is a wearable device for collecting patients’ physiological data, that includes a single-use adhesive-gel electrode placed on the forehead, and the Somfit device, which is pressed onto the electrode.

Sponsors

Queensland Children’s Hospital
Lead SponsorHospital

Study design

Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Diagnosis
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
4 Years to 18 Years
Healthy volunteers
No

Inclusion criteria

Undergoing in-hospital polysomnography as part of routine care

Exclusion criteria

• Treatment (including continuous positive airway pressure, mechanical ventilation, or supplemental oxygen) is commenced during The polysomnography study

Outcome results

None listed

Source: ANZCTR · Data processed: Jul 3, 2026