Back to resultsfNIRS in Pediatric Hearing Aids (FNIRS)
Primary Purpose
Hearing Loss
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
speech audiometry
Sponsored by
About this trial
This is an interventional diagnostic trial for Hearing Loss focused on measuring NIRS, hearing aid, pediatrics, cochlear implant, rehabilitation, neuroimaging
Eligibility Criteria
Inclusion Criteria:
- Group A: Infants and toddlers 3-18 months of age who are normal hearing.
- Group B: Infants and toddlers aged 3 to 18 months with sensorineural hearing loss fitted with a unilateral or bilateral hearing aid with optimized adjustments by the hearing healthcare professional.
- Socially insured subject
- Parents or guardians who have given their consent to participate in the study
Exclusion Criteria:
- Medical condition that does not allow for research compliance.
Sites / Locations
- Hopital Roger Salengro, CHU LilleRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
children with hearing aids
control group
Arm Description
Outcomes
Primary Outcome Measures
Oxygenated haemoglobin concentration (HbO)
Secondary Outcome Measures
Deoxygenated haemoglobin concentration (HbR)
HbO Concentration
Evolution of the variation in HbO concentration in the group of infants fitted with a device.
HbR Concentration
Evolution of the variation in HbR concentration in the group of infants fitted with a device.
Full Information
NCT ID
NCT04696835
First Posted
January 5, 2021
Last Updated
March 1, 2022
Sponsor
University Hospital, Lille
Collaborators
Fondation William Demant
1. Study Identification
Unique Protocol Identification Number
NCT04696835
Brief Title
fNIRS in Pediatric Hearing Aids
Acronym
FNIRS
Official Title
Use of Near-infrared Functional Spectroscopy (fNIRS) in the Evaluation of Hearing Rehabilitation in Children With Hearing Aid(s)
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 9, 2021 (Actual)
Primary Completion Date
September 2025 (Anticipated)
Study Completion Date
September 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Lille
Collaborators
Fondation William Demant
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Loss
Keywords
NIRS, hearing aid, pediatrics, cochlear implant, rehabilitation, neuroimaging
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
children with hearing aids
Arm Type
Experimental
Arm Title
control group
Arm Type
Sham Comparator
Intervention Type
Diagnostic Test
Intervention Name(s)
speech audiometry
Intervention Description
65dB, 55dB or 75dB SPL speech audiometry
Primary Outcome Measure Information:
Title
Oxygenated haemoglobin concentration (HbO)
Time Frame
Baseline (at inclusion)
Secondary Outcome Measure Information:
Title
Deoxygenated haemoglobin concentration (HbR)
Time Frame
Baseline (at inclusion)
Title
HbO Concentration
Description
Evolution of the variation in HbO concentration in the group of infants fitted with a device.
Time Frame
At 3 months, 6 months, 12 months and 24 months
Title
HbR Concentration
Description
Evolution of the variation in HbR concentration in the group of infants fitted with a device.
Time Frame
At 3 months, 6 months, 12 months and 24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Months
Maximum Age & Unit of Time
18 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Group A: Infants and toddlers 3-18 months of age who are normal hearing.
Group B: Infants and toddlers aged 3 to 18 months with sensorineural hearing loss fitted with a unilateral or bilateral hearing aid with optimized adjustments by the hearing healthcare professional.
Socially insured subject
Parents or guardians who have given their consent to participate in the study
Exclusion Criteria:
Medical condition that does not allow for research compliance.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christophe VINCENT, PU-PH
Phone
0320445962
Ext
+33
Email
christophe.vincent@chru-lille.Fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christophe VINCENT, PU-PH
Organizational Affiliation
University Hospital, Lille
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hopital Roger Salengro, CHU Lille
City
Lille
ZIP/Postal Code
59037
Country
France
Individual Site Status
Recruiting
Facility Contact:
Phone
0320445962
12. IPD Sharing Statement
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fNIRS in Pediatric Hearing Aids
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