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

NCT07421349 | Not Yet Recruiting

• 1 other identifier: 25.08.2025-206906
• Study Type: observational
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Respiratory Muscle Strength; Children; Hearing Loss, Bilateral Sensorineural; Pulmonary Function

Outcome Measures

Primary Outcomes (2)

• 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.

  At baseline (single assessment)

• 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.

  At baseline (single assessment)

Secondary Outcomes (5)

• Forced Vital Capacity (FVC)

  At baseline (single assessment)

• Forced Expiratory Volume in 1 Second (FEV1)

  At baseline (single assessment)

• FEV1/FVC Ratio

  At baseline (single assessment)

• Peak Expiratory Flow (PEF)

  At baseline (single assessment)

• Forced Expiratory Flow 25-75% (FEF25-75%)

  At baseline (single assessment)

Study Arms (2)

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 \[MEP\]).

Eligibility Criteria

• Age: 7 Years - 16 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Bezmialem Vakif University: lead

MeSH Terms

Conditions

Hearing Loss

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Deniz Tuncer, PhD, PT

CONTACT

+90212 401 26 00; dtuncer@bezmialem.edu.tr

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 12, 2026
• First Posted: February 19, 2026
• Study Start: February 20, 2026
• Primary Completion: March 30, 2026
• Study Completion: March 30, 2026
• Last Updated: February 19, 2026

Record last verified: 2026-02