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

February 12, 2026 updated by: Deniz Tuncer, Bezmialem Vakif University

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.

Study Overview

Status

Not yet recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study 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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Children With Hearing Loss
Children aged 7-16 years diagnosed with hearing loss. Participants will undergo pulmonary function testing using spirometry and assessment of respiratory muscle strength (maximum inspiratory pressure [MIP] and maximum expiratory pressure [MEP]).
Healthy Controls
Age- and sex-matched healthy children aged 7-16 years without hearing impairment. Participants will undergo pulmonary function testing using spirometry and assessment of respiratory muscle strength (maximum inspiratory pressure [MIP] and maximum expiratory pressure [MEP]).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
At baseline (single assessment)
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.
At baseline (single assessment)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
At baseline (single assessment)
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.
At baseline (single assessment)
FEV1/FVC Ratio
Time Frame: At baseline (single assessment)
Ratio of FEV1 to FVC obtained from spirometric assessment.
At baseline (single assessment)
Peak Expiratory Flow (PEF)
Time Frame: At baseline (single assessment)
Peak expiratory flow measured by spirometry.
At baseline (single assessment)
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.
At baseline (single assessment)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bezmialem Vakif University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 20, 2026

Primary Completion (Estimated)

March 30, 2026

Study Completion (Estimated)

March 30, 2026

Study Registration Dates

First Submitted

February 12, 2026

First Submitted That Met QC Criteria

February 12, 2026

First Posted (Actual)

February 19, 2026

Study Record Updates

Last Update Posted (Actual)

February 19, 2026

Last Update Submitted That Met QC Criteria

February 12, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 25.08.2025-206906

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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