About this trial
This study aims to compare pulmonary function and respiratory muscle strength between children with hearing impairment and their healthy peers. Hearing plays a critical role not only in communication but also in cognitive, sensory, and psychomotor development. Children with hearing impairment may experience balance and coordination problems, vestibular dysfunction, and reduced muscle strength, which may negatively affect respiratory function.
Although several studies have evaluated pulmonary function in children with hearing impairment, research investigating respiratory muscle strength in this population is limited. To our knowledge, no peer-reviewed study has directly compared respiratory muscle strength between children with hearing impairment and healthy controls.
This study will compare spirometric parameters and respiratory muscle strength measurements between children with hearing impairment and age-matched healthy controls.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Aged between 7 and 16 years
Diagnosed with hearing loss
No neurological or orthopedic disorders
No syndrome and/or disease causing intellectual disability, developmental disorder, or visual impairment
Disqualifiers
Intellectual disability preventing participation in assessment procedures
Presence of chronic respiratory disease
Inability to perform pulmonary function or respiratory muscle strength tests properly
Trial population
The study population consists of children aged 7 to 16 years. The hearing loss group includes children diagnosed with hearing impairment who are followed in relevant clinical or educational settings. The control group consists of age- and sex-matched healthy children without hearing impairment. All participants will be screened according to the predefined inclusion and exclusion criteria prior to enrollment.
Trial design
Case-control
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Maximum Inspiratory Pressure (MIP)
Respiratory muscle strength assessed by measuring maximum inspiratory pressure (cmH₂O) using a portable electronic mouth pressure device (MicroRPM) according to ATS/ERS guidelines.
Maximum Expiratory Pressure (MEP)
Forced vital capacity measured by spirometry (COSMED Pony FX) according to ATS/ERS criteria; values expressed as absolute and percentage of predicted values.
Secondary outcomes
Forced Vital Capacity (FVC)
Forced vital capacity measured by spirometry (COSMED Pony FX) according to ATS/ERS criteria; values expressed as absolute and percentage of predicted values.
Forced Expiratory Volume in 1 Second (FEV1)
Forced expiratory volume in the first second measured by spirometry; values expressed as absolute and percentage of predicted values.
FEV1/FVC Ratio
Ratio of FEV1 to FVC obtained from spirometric assessment.
Peak Expiratory Flow (PEF)
Peak expiratory flow measured by spirometry.
Locations
Sponsors and contacts
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