Trials / Recruiting
RecruitingNCT04696835
fNIRS in Pediatric Hearing Aids
Use of Near-infrared Functional Spectroscopy (fNIRS) in the Evaluation of Hearing Rehabilitation in Children With Hearing Aid(s)
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- Sponsor
- University Hospital, Lille · Academic / Other
- Sex
- All
- Age
- 3 Months – 18 Months
- Healthy volunteers
- Not accepted
Summary
Pilot phase. Monocentric, non-controlled, non-randomized, open-label study evaluating the capacity of the functional near-infrared functional neuroimaging (fNIRS) technique to translate temporal cortical activity in response to a speech stimulus in normo-hearing and deaf children with cochlear implants. Hemodynamic changes are expected to be observed that indicate brain activity following the stimuli, resulting in a change in the concentration of oxygenated hemoglobin (HbO) and deoxygenated hemoglobin (HbR) recorded by the fNIRS. The use of the FNIRS in the evaluation of hearing aid effectiveness could contribute to a more adapted management of childhood hearing loss since conventional methods in young children are not adapted to the needs of children with hearing loss.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIAGNOSTIC_TEST | speech audiometry | 65dB, 55dB or 75dB SPL speech audiometry |
Timeline
- Start date
- 2021-09-09
- Primary completion
- 2027-09-01
- Completion
- 2027-09-01
- First posted
- 2021-01-06
- Last updated
- 2025-12-24
Locations
1 site across 1 country: France
Source: ClinicalTrials.gov record NCT04696835. Inclusion in this directory is not an endorsement.