Hearing Intervention Effects on Brain and Language Development in Children With Bilateral Mild Hearing Loss

Browse trials for

• Hearing Loss, Bilateral 55

Keywords

• Mild hearing loss
• Hearing aids
• Brain development
• Children

Hearing Loss, Bilateral

55 studies on the registry are indexed under Hearing Loss, Bilateral; 17 are open to participants now.

This study's planned enrollment of 260 is above the median of 30 across 42 interventional studies indexed under Hearing Loss, Bilateral.

Lead sponsor

Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University is the lead sponsor of 164 studies on the registry; 73 are open to participants now.

Study arms

• Experimental
  Hearing-aid intervention

  Participants in the hearing-aid intervention group will receive standardized bilateral fitting of behind-the-ear (BTE) hearing aids, and their parents will be instructed to ensure consistent daily use for 12 months and be provided with essential knowledge regarding hearing aid maintenance and proper usage. In addition, the same hearing-care education sessions will also be delivered to this group.

  Device: Behind-the-ear (BTE) hearing aids · Other: Hearing-care educational sessions

• Other
  Hearing-care education

  Participants in the hearing-care education control group will not receive hearing aids, but will receive standardized hearing-care educational sessions at each follow-up visit.

  Other: Hearing-care educational sessions

Interventions

• DeviceBehind-the-ear (BTE) hearing aids

  Bilateral BTE hearing aids will be uniformly provided by the project team and fitted and verified by experienced audiologists at participating sites, with settings adjusted to achieve optimal hearing status according to individual needs. The devices will be selected from mainstream BTE hearing aid brands and models that are already commercially available in China and widely used in pediatric populations.

• OtherHearing-care educational sessions

  Standardized educational sessions covering children hearing and speech development, pediatric hearing care, routine monitoring and detection, and appropriate family support and parent-child interaction delivered by trained researchers during each follow-up visit.

Primary outcomes

1. Children overall development, as measured by General Developmental Quotient (GDQ) from the Griffiths Development Scales - Chinese Edition (GDS-C)

   The GDS-C was adapted from the 2006 Griffiths Mental Development Scales - Extended Revised (GMDS-ER) and standardized with Chinese norms for children aged 0-8 years. It evaluates six subdomains: (A) Locomotor, (B) Personal-Social, (C) Language, (D) Eye \& Hand Coordination, (E) Performance, and (F) Practical Reasoning. The General Developmental Quotient (GDQ) is derived as:(developmental age ÷ chronological age) × 100. Higher scores indicate better overall developmental status.

   Time frame: From enrollment to 12 months, with assessments at 0, 6, and 12 months.

Secondary outcomes

1. Griffiths Development Scales-Chinese Edition (GDS-C) subscale quotients

   Including six subscales: Locomotor (A), Personal-Social (B), Language (C), Eye-hand Co-ordination (D), Performance (E), and Practical Reasoning (F). Each subscale quotient is calculated as (subscale developmental age ÷ chronological age) × 100. Higher subscale quotients indicate better performance in the specific domain.

   Time frame: From enrollment to 12 months, with assessments at 0, 6, and 12 months.

2. MRI outcomes

   Brain structure and function changes evaluated by MRI

   Time frame: Assessed at 0 and 12 months.

3. Auditory Brainstem Response (ABR)

   Electrical potentials recorded with scalp electrodes in response to electrical stimulation of the cochlear nerve. The ABR threshold will be measured in decibels normal hearing level (dB nHL) for each ear. Lower thresholds indicate better auditory function.

   Time frame: From enrollment to 12 months, with assessments at 0, 6, and 12 months.

4. Behavioral audiometry thresholds (Pure-Tone Audiometry)

   Behavioral audiometry measures the lowest pure tone level children can respond. Its thresholds will be measured in decibels hearing level (dB HL) for each ear at standard frequencies. The Pure Tone Average (PTA) will be calculated by the average of four frequencies (0.5, 1, 2, 4 kHz). Lower thresholds indicate better hearing.

   Time frame: From enrollment to 12 months, with assessments at 0, 6, and 12 months.

5. Word Recognition Score

   Measured by percentage of correctly identified words (ranging from 0% to 100%) from standardized Mandarin Chinese word lists, presented in a quiet sound booth. Higher percentages indicate better speech perception ability.

   Time frame: From enrollment to 12 months, with assessments at 0, 6, and 12 months.

6. Categories of Auditory Performance (CAP) Score

   The Categories of Auditory Performance (CAP) is a hierarchical rating scale assessing real-life auditory functioning. It comprises 10 categories graded from 0 to 9, where 0 = "cannot detect environmental or speech sounds" and 9 = "able to use the telephone with an unfamiliar speaker in unpredictable situations". Higher scores indicating better auditory performance.

   Time frame: From enrollment to 12 months, with assessments at 0, 6, and 12 months.

7. Speech Intelligibility Rating (SIR) Score

   The Speech Intelligibility Rating (SIR) is a hierarchical rating scale assessing the intelligibility of a child's speech in everyday communication. It comprises 5 categories graded from 1 to 5, with higher scores indicating greater speech intelligibility.

   Time frame: From enrollment to 12 months, with assessments at 0, 6, and 12 months.

8. Meaningful Auditory Integration Scale (MAIS/IT-MAIS) Score

   This scale includes the original MAIS version for children aged ≥3 years and the IT-MAIS (Infant-Toddler version) for children \<3 years. It is a parent-report structured interview designed to assess the child's spontaneous auditory responses in everyday environments, consisting of 10 items evaluating three domains: vocalization behavior, alerting to sounds, and deriving meaning from sound. Each item is scored from 0 to 4, yielding a total score ranging from 0 to 40. Higher scores indicate better auditory integration ability.

   Time frame: From enrollment to 12 months, with assessments at 0, 6, and 12 months.

9. Meaningful Use of Speech Scale (MUSS) Score

   The Meaningful Use of Speech Scale (MUSS) assesses speech production and communication ability. It comprises 10 open-ended questions answered by parents/guardians, each scored 0-4). The total score ranges from 0 to 40, with higher scores indicating better speech use. Scores are often reported as percentages (score ÷ 40 × 100%).

   Time frame: From enrollment to 12 months, with assessments at 0, 6, and 12 months.

10. Adaptive behavior measured by Adaptive Behavior Assessment System, Second Edition (ABAS-II)

    The ABAS-II is a comprehensive, norm-referenced assessment of adaptive functioning across multiple skill areas relevant to daily living. Depending on the respondent form used, it yields a General Adaptive Composite (GAC) as an overall standard score (mean = 100, SD = 15), three domain composite scores (Conceptual, Social, and Practical), and individual skill area scaled scores covering domains such as Communication, Community Use, Functional Academics, Home Living, Health and Safety, Leisure, Self-Care, Self-Direction, Social, Work (where applicable), and Motor. Higher scores consistently indicating more advanced adaptive functioning.

    Time frame: From enrollment to 12 months, with assessments at 0, 6, and 12 months.

Other outcomes

1. Distortion Product Otoacoustic Emissions (DPOAE) Amplitude and Signal-to-Noise Ratio

   DPOAEs were recorded bilaterally at standard frequencies. For each frequency, the DPOAE amplitude (in dB SPL) and signal-to-noise ratio (SNR, in dB) were obtained. The amplitude represents the absolute sound pressure level of the distortion product response, while the SNR is the difference between the amplitude and the background noise floor at the same frequency. Higher amplitude and SNR indicate stronger outer hair cell (OHC)-mediated cochlear amplification and better cochlear function. A DPOAE response is conventionally considered present (PASS) when the SNR exceeds 6 dB.

   Time frame: From enrollment to 12 months, with assessments at 0, 6, and 12 months.

2. Acoustic Immittance

   Acoustic immittance is measured via tympanometry using a 226-Hz probe tone. Three quantitative parameters are reported: tympanometric peak pressure (measured in daPa), peak compensated static admittance (measured in mmho), and equivalent ear canal volume (measured in mL). Results are classified as pass or fail based on standardized criteria.

   Time frame: From enrollment to 12 months, with assessments at 0, 6, and 12 months.

3. Family Environment Survey

   Including basic family environment survey, and Index of Child Care Environment (ICCE)

   Time frame: From enrollment to 12 months, with assessments at 0, 6, and 12 months.

Individual participant data

Plan to share: Yes

Supporting information: Study protocol, Statistical analysis plan

Time frame: The protocol will be available from study initiation, before the first participant is enrolled. The final version of SAP will be approved before database lock and will be shared 6 months after the primary results are published.