Comparison of Pulmonary Functions and Respiratory Muscle Strength Between Children With Hearing Impairment and Healthy Peers

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age7-16
SponsorBezmialem Vakif University

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 volunteers

Qualifiers

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

Design model

Case-control

Time perspective

Cross-sectional

Treatments tested in this trial

Not listed

Trial groups

30 Participants
are grouped into 2 trial groups
Group A: Children With Hearing Loss
Group B: Healthy Controls

Trial outcomes

Primary outcomes

1

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.

Time frame
At baseline (single assessment)
2

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.

Time frame
At baseline (single assessment)

Secondary outcomes

1

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.

Time frame
At baseline (single assessment)
2

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.

Time frame
At baseline (single assessment)
3

FEV1/FVC Ratio

Ratio of FEV1 to FVC obtained from spirometric assessment.

Time frame
At baseline (single assessment)
4

Peak Expiratory Flow (PEF)

Peak expiratory flow measured by spirometry.

Time frame
At baseline (single assessment)

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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