跳至主要内容
临床试验/NCT07421349
NCT07421349已完成不适用

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

Bezmialem Vakif University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2026年2月20日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
1
主要终点
Maximum Inspiratory Pressure (MIP)

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

年龄范围
7 Years 至 16 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • (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

研究组 & 干预措施

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]).

结局指标

主要结局

Maximum Inspiratory Pressure (MIP)

时间窗: 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.

Maximum Expiratory Pressure (MEP)

时间窗: 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.

次要结局

  • 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))
  • Forced Vital Capacity (FVC)(At baseline (single assessment))
  • Forced Expiratory Volume in 1 Second (FEV1)(At baseline (single assessment))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Deniz Tuncer

Assistant Professor

Bezmialem Vakif University

研究点 (1)

Loading locations...

相似试验

Comparison of Pulmonary Functions and Respiratory... | 临床试验