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Completed

NCT Number: NCT07421349

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

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.

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Key information

Conditions

Hearing Loss, Bilateral Sensorineural Children Ear Diseases Hearing Disorders Hearing Loss Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Pulmonary Function Respiratory Muscle Strength Sensation Disorders Signs and Symptoms

Age range

7 year–16 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Bezmialem Vakif University

Istanbul, Sakarya, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

For Children With Hearing Loss Group:

  • 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
  • No use of medication affecting respiratory function within the last 3 months
  • Written informed consent obtained from parent or legal guardian

For Healthy Control Group:

  • Aged between 7 and 16 years
  • No hearing impairment
  • No neurological or orthopedic disorders
  • No syndrome and/or disease causing intellectual disability, developmental disorder, or visual impairment
  • No use of medication affecting respiratory function within the last 3 months
  • Written informed consent obtained from parent or legal guardian

Exclusion criteria

(Both Groups)

  • Intellectual disability preventing participation in assessment procedures
  • Presence of chronic respiratory disease
  • Inability to perform pulmonary function or respiratory muscle strength tests properly

Treatment and study plan

Primary outcomes

  1. Maximum Inspiratory Pressure (MIP)

    Time frame: At baseline (single assessment)

    Respiratory muscle strength assessed by measuring maximum inspiratory pressure (cmH₂O) using a portable electronic mouth pressure device (MicroRPM) according to ATS/ERS guidelines.

  2. Maximum Expiratory Pressure (MEP)

    Time frame: At baseline (single assessment)

    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

  1. Forced Vital Capacity (FVC)

    Time frame: At baseline (single assessment)

    Forced vital capacity measured by spirometry (COSMED Pony FX) according to ATS/ERS criteria; values expressed as absolute and percentage of predicted values.

  2. Forced Expiratory Volume in 1 Second (FEV1)

    Time frame: At baseline (single assessment)

    Forced expiratory volume in the first second measured by spirometry; values expressed as absolute and percentage of predicted values.

  3. FEV1/FVC Ratio

    Time frame: At baseline (single assessment)

    Ratio of FEV1 to FVC obtained from spirometric assessment.

  4. Peak Expiratory Flow (PEF)

    Time frame: At baseline (single assessment)

    Peak expiratory flow measured by spirometry.

  5. Forced Expiratory Flow 25-75% (FEF25-75%)

    Time frame: At baseline (single assessment)

    Forced expiratory flow between 25% and 75% of FVC measured by spirometry.

Sponsors and collaborators

Lead sponsor

Bezmialem Vakif University

Other

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 19, 2026
Registry last updated
Jul 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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