Vestibular DisorderNCT05865769
Impact of Pulmonary Function on Vestibular System in Children
An observational study of Vestibular Disorder and Pulmonary Disease, run by Kafrelsheikh University.
Trial summary
The vestibular system and the pulmonary system are two critical components of the human body that are involved in maintaining balance, coordination, and the exchange of oxygen and carbon dioxide This study aim to investigate the impact of pulmonary function on the vestibular system in children. Read more about this study
- Who is it for?
- Ages 6 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Vestibular Disorder, Pulmonary Disease
- What is being tested?
- Balance
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 20 Dec 2023to 20 Dec 2024
- 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 6 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Children were recruited from Future Academy School. Children were included in the current study if their age is between 4 and 10 years old, also all children are free of asthma and other respiratory diseases. They were excluded if they had surgery or previous trauma over the chest. 62 children were recruited at the start of the current study; 5 children are older than the proposed sample while the parents of the other 5 refused to enter the study then the sample was classified according to FEV1 into 2 equal number classes (Low and high FEV1) according to median also 4 records were excluded as they are so extreme then the Mini-SITCIB test was used to measure balance in 4 conditions to test vision, proprioception and vestibular systems.
Who may be able to join
- Children will be recruited from Future Academy School. Children will be included in the current study if their age is between 4 and 10 years old, also all children are free of asthma and other respiratory diseases.
Who cannot join
- They were excluded if they had surgery or previous trauma over the chest.
About this study
The vestibular system and the pulmonary system are two critical components of the human body that are involved in maintaining balance, coordination, and the exchange of oxygen and carbon dioxide This study aim to investigate the impact of pulmonary function on the vestibular system in children.
Children aged 4 to 10 years will be recruited from Future Academy School in March 2023. Pulmonary function will be measured using digital spirometry, and balance will be evaluated using the Mini-SITCIB test, which tested vision, proprioception, and the vestibular system using mobile sensors fixed near the center of gravity. Features from the sensor data will be extracted using Python 3.10 code, and the SPSS program will used to compare these features between the two groups.
Read the detailed description
The procedures of the current study will be explained to the children and their parents then parents read and sign an informed consent form.
Spirometry (spirOx plus, MEDITECH, China) will be used in the current study; Hand-held lung function test equipment uses infrared signal acquisition methods to measure the forced vital capacity-related items. It has a compact design, is lightweight and is convenient to carry and use; also, it uses low power consumption and can store up to 200 test cases. It can measure forced vital capacity (FVC), forced expiratory volume in the first second (FEV1), peak expiratory flow (PEF) and PEF in 25%, 50%, and 75% also the device may provide percentages like FEV1/FVC, and FEP25/75. This device has proven to be valid and reliable to measure spirometry functions.
Phyphox application will be used(physical phone experiment, version 1.1.7), a free program with at least 30 functions for proceeding with physics experiments. The application is named phyphox (an acronym for physical phone experiments) and bosom on Google's Play Store and Apple's App Store in September 2016. To buttress users about the world, an accompanying website was created at http://phyphox.org, which offers itemized instructions, demonstration videos and technical information in English and German. The app itself is presently being translated into additional languages by volunteers from all around the world. The application can use the remote access option to transfer the screen to another monitor wirelessly; also, the app can measure acceleration, gyroscope, linear acceleration, and magnetometer readings. Also exporting the results is available on the wireless screen. This application is proven to be valid and reliable to measure the sensor's readings.
After obtaining the consent form, some demographic data like gender, age, weight, height and BMI were collected then each child was asked to take a deep breath and then expire for 6 sec at the spirometer.
The mobile application will be opened, and a new experiment will be created with the following criteria: sensors are acceleration, gyroscope, linear acceleration and magnetometer, the sampling rate is 800 Hz, the Experiment time is 30 sec with a 3-sec delay, then the remote access option will be enabled so that the screen appears on laptop screen wirelessly.
Abdominal support will be modified so it contains a pocket in its centre so the mobile can fit onto it. Then the mobile phone with the application opened on its screen will be fitted in the pocket in the modified belt, so when the belt is attached the mobile sensors will be very close to the centre of gravity of the participant. After wrapping the belt, participants will be asked to conduct a mini-SITCIB test. For each condition, they will be asked to stand as the condition states for 30 sec and start counting when the application starts recording the sensors data, the conditions are as follows: opened eye with the fixed surface, the closed eye with the fixed surface, opened eye with movable surface and closed eye with the movable surface. Finally, the data will be extracted and stored anonymously on the hard drive as CSV files. The condition test is over when (a) the participant opens his/her eyes in an eyes-closed condition, (b) raises arms from sides, (c) loses balance and requires manual assistance to prevent a fall.
- Conditions
- Vestibular Disorder, Pulmonary Disease
- Being tested
- Balance
- Medical subject headings
- Vestibular Diseases, Lung Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BalanceOther
measuring pulmonary and vestibular functions in all subjects
| Study group | Role | What they receive |
|---|---|---|
| Normal children | Have FEV1 higher than median on their class Receives: Other: Balance | |
| subclinical pulmonary impairment | Have FEV1 lower than median on their class Receives: Other: Balance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Root Mean Square (RMS) swaying of COG in X,Y,Z
mm
Measured: 2 weeks
Frequency of swaying in X,Y,Z
Hz
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2023
- Study start20 Dec 2023 (estimated)
- Primary completion20 Dec 2024 (estimated)
- Study completion20 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vestibular DisorderStudies of the same condition, open and under way.
- More trials run by Kafrelsheikh 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kafrelsheikh University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Ali Mohammed Torad, Kafrelsheikh University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05865769
- Sponsor's protocol ID
- P.T/PED/2/2023/41
- Status last verified
- May 2023
- First submitted
- 20 Apr 2023
- Last updated
- 19 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: upon request
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Pulmonary Function on Vestibular System in Children
- ClinicalTrials.gov ID
- NCT05865769
- Acronym / sponsor ID
- P.T/PED/2/2023/41
- Conditions
- Vestibular Disorder, Pulmonary Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Kafrelsheikh UniversityUniversity, hospital or other
- Study start
- 20 Dec 2023 (estimated)
- Primary completion
- 20 Dec 2024 (estimated)
- Study completion
- 20 Dec 2024 (estimated)
- First posted
- 19 May 2023 (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.
The vestibular system and the pulmonary system are two critical components of the human body that are involved in maintaining balance, coordination, and the exchange of oxygen and carbon dioxide This study aim to investigate the impact of pulmonary function on the vestibular system in children.
Children aged 4 to 10 years will be recruited from Future Academy School in March 2023. Pulmonary function will be measured using digital spirometry, and balance will be evaluated using the Mini-SITCIB test, which tested vision, proprioception, and the vestibular system using mobile sensors fixed near the center of gravity. Features from the sensor data will be extracted using Python 3.10 code, and the SPSS program will used to compare these features between the two groups.
Detailed description
The procedures of the current study will be explained to the children and their parents then parents read and sign an informed consent form.
Spirometry (spirOx plus, MEDITECH, China) will be used in the current study; Hand-held lung function test equipment uses infrared signal acquisition methods to measure the forced vital capacity-related items. It has a compact design, is lightweight and is convenient to carry and use; also, it uses low power consumption and can store up to 200 test cases. It can measure forced vital capacity (FVC), forced expiratory volume in the first second (FEV1), peak expiratory flow (PEF) and PEF in 25%, 50%, and 75% also the device may provide percentages like FEV1/FVC, and FEP25/75. This device has proven to be valid and reliable to measure spirometry functions.
Phyphox application will be used(physical phone experiment, version 1.1.7), a free program with at least 30 functions for proceeding with physics experiments. The application is named phyphox (an acronym for physical phone experiments) and bosom on Google's Play Store and Apple's App Store in September 2016. To buttress users about the world, an accompanying website was created at http://phyphox.org, which offers itemized instructions, demonstration videos and technical information in English and German. The app itself is presently being translated into additional languages by volunteers from all around the world. The application can use the remote access option to transfer the screen to another monitor wirelessly; also, the app can measure acceleration, gyroscope, linear acceleration, and magnetometer readings. Also exporting the results is available on the wireless screen. This application is proven to be valid and reliable to measure the sensor's readings.
After obtaining the consent form, some demographic data like gender, age, weight, height and BMI were collected then each child was asked to take a deep breath and then expire for 6 sec at the spirometer.
The mobile application will be opened, and a new experiment will be created with the following criteria: sensors are acceleration, gyroscope, linear acceleration and magnetometer, the sampling rate is 800 Hz, the Experiment time is 30 sec with a 3-sec delay, then the remote access option will be enabled so that the screen appears on laptop screen wirelessly.
Abdominal support will be modified so it contains a pocket in its centre so the mobile can fit onto it. Then the mobile phone with the application opened on its screen will be fitted in the pocket in the modified belt, so when the belt is attached the mobile sensors will be very close to the centre of gravity of the participant. After wrapping the belt, participants will be asked to conduct a mini-SITCIB test. For each condition, they will be asked to stand as the condition states for 30 sec and start counting when the application starts recording the sensors data, the conditions are as follows: opened eye with the fixed surface, the closed eye with the fixed surface, opened eye with movable surface and closed eye with the movable surface. Finally, the data will be extracted and stored anonymously on the hard drive as CSV files. The condition test is over when (a) the participant opens his/her eyes in an eyes-closed condition, (b) raises arms from sides, (c) loses balance and requires manual assistance to prevent a fall.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normal children | – | Other: BalanceHave FEV1 higher than median on their class |
| subclinical pulmonary impairment | – | Other: BalanceHave FEV1 lower than median on their class |
Who may qualify
- Ages
- 6 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Children were recruited from Future Academy School. Children were included in the current study if their age is between 4 and 10 years old, also all children are free of asthma and other respiratory diseases. They were excluded if they had surgery or previous trauma over the chest. 62 children were recruited at the start of the current study; 5 children are older than the proposed sample while the parents of the other 5 refused to enter the study then the sample was classified according to FEV1 into 2 equal number classes (Low and high FEV1) according to median also 4 records were excluded as they are so extreme then the Mini-SITCIB test was used to measure balance in 4 conditions to test vision, proprioception and vestibular systems.
Key inclusion criteria (1 listed)
- Children will be recruited from Future Academy School. Children will be included in the current study if their age is between 4 and 10 years old, also all children are free of asthma and other respiratory diseases.
Key exclusion criteria (1 listed)
- They were excluded if they had surgery or previous trauma over the chest.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Balancemeasuring pulmonary and vestibular functions in all subjects | Other | Normal children, subclinical pulmonary impairment |
Primary outcome
Root Mean Square (RMS) swaying of COG in X,Y,Z
Time frame: 2 weeks
mm
Frequency of swaying in X,Y,Z
Time frame: 2 weeks
Hz
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2023.
- Individual participant dataSharing planned: Undecided. upon request
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Vestibular Disorder and Pulmonary Disease, run by Kafrelsheikh University.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 19 May 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Root Mean Square (RMS) swaying of COG in X,Y,Z (time frame: 2 weeks). 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 19 May 2023.