Hearing Loss, Bilateral SensorineuralNCT07421349
Comparison of Pulmonary Functions and Respiratory Muscle Strength Between Children With Hearing Impairment and Healthy Peers
An observational study of Hearing Loss, Bilateral Sensorineural and Pulmonary Function, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Hearing Loss, Bilateral Sensorineural, Pulmonary Function, Respiratory Muscle Strength
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Feb 2026to 30 Jun 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
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.
Who may be able to join
- 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
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- 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
Who cannot join
- Intellectual disability preventing participation in assessment procedures
- Presence of chronic respiratory disease
- Inability to perform pulmonary function or respiratory muscle strength tests properly
Trial locations and contacts
1 site in 1 country.
About this study
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
- Hearing Loss, Bilateral Sensorineural, Pulmonary Function, Respiratory Muscle Strength, Children
- Medical subject headings
- Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: At baseline (single assessment)
Secondary outcomes (5)
Forced Vital Capacity (FVC)
Forced vital capacity measured by spirometry (COSMED Pony FX) according to ATS/ERS criteria; values expressed as absolute and percentage of predicted values.
Measured: At baseline (single assessment)
Forced Expiratory Volume in 1 Second (FEV1)
Forced expiratory volume in the first second measured by spirometry; values expressed as absolute and percentage of predicted values.
Measured: At baseline (single assessment)
FEV1/FVC Ratio
Ratio of FEV1 to FVC obtained from spirometric assessment.
Measured: At baseline (single assessment)
Peak Expiratory Flow (PEF)
Peak expiratory flow measured by spirometry.
Measured: At baseline (single assessment)
Forced Expiratory Flow 25-75% (FEF25-75%)
Forced expiratory flow between 25% and 75% of FVC measured by spirometry.
Measured: At baseline (single assessment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2026
- Study start20 Feb 2026
- Primary completion30 Jun 2026
- Study completion30 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hearing Loss, Bilateral SensorineuralStudies of the same condition, open and under way.
- More trials run by Bezmialem Vakif UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bezmialem Vakif University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Deniz Tuncer, Bezmialem Vakif University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07421349
- Sponsor's protocol ID
- 25.08.2025-206906
- Status last verified
- Feb 2026
- First submitted
- 12 Feb 2026
- Last updated
- 13 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Pulmonary Functions and Respiratory Muscle Strength Between Children With Hearing Impairment and Healthy Peers
- ClinicalTrials.gov ID
- NCT07421349
- Acronym / sponsor ID
- 25.08.2025-206906
- Conditions
- Hearing Loss, Bilateral Sensorineural, Pulmonary Function, Respiratory Muscle Strength, Children
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Bezmialem Vakif UniversityUniversity, hospital or other
- Study start
- 20 Feb 2026 (actual)
- Primary completion
- 30 Jun 2026 (actual)
- Study completion
- 30 Jun 2026 (actual)
- First posted
- 19 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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]). |
Who may qualify
- Ages
- 7 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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.
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (3 listed)
- Intellectual disability preventing participation in assessment procedures
- Presence of chronic respiratory disease
- Inability to perform pulmonary function or respiratory muscle strength tests properly
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
5 secondary outcomes
Forced Vital Capacity (FVC)
Time frame: At baseline (single assessment)
Forced Expiratory Volume in 1 Second (FEV1)
Time frame: At baseline (single assessment)
FEV1/FVC Ratio
Time frame: At baseline (single assessment)
Peak Expiratory Flow (PEF)
Time frame: At baseline (single assessment)
Forced Expiratory Flow 25-75% (FEF25-75%)
Time frame: At baseline (single assessment)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hearing Loss, Bilateral Sensorineural and Pulmonary Function, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Inspiratory Pressure (MIP) (time frame: At baseline (single assessment)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2026.