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

July 10, 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

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

Contacts and Locations

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

Study Locations

Turkey (Türkiye)
- Sakarya
  - Istanbul, Sakarya, Turkey (Türkiye)
    - Bezmialem Vakif University

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

Number of groups / cohorts

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 (Actual)

February 20, 2026

Primary Completion (Actual)

June 30, 2026

Study Completion (Actual)

June 30, 2026

Study Registration Dates

First Submitted

February 12, 2026

First Submitted That Met QC Criteria