Vestibular DisorderNCT04280211
Does Vestibular System Effected in Chronic Obstructive Pulmonary Disease Patients
An observational study of Vestibular Disorder, run by Nimet Sermenli Aydın.
Trial summary
. The main question is whether the vestibular system is affected by COPD. If there is an influence, the second question is what is the relationship between balance and vestibular interaction in COPD patients. A total of 10 COPD patients and 10 healthy adults will include the study. Read more about this study
- Who is it for?
- Ages 40 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Vestibular Disorder
- What is being tested?
- Respiratory Assessment, Vestibular Assessment and Balance Assessment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 25 Feb 2024to 15 Jun 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 40 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study group will be selected from Respiratory Disease Hospital - (Süreyyapaşa Göğüs Hastalıkları ve Göğüs Cerrahisi Eğitim ve Araştırma Hastanesi) The control group will be invited from the community by announcements.
Who may be able to join
- Volunteering to participate in the study
- Diagnosed with COPD
- Volunteering to participate in the study
Who cannot join
- Communication - Coordination problems of patients
- Using medicine which is increasing the risk of fall
- Any neurologic or musculoskeletal disorders which affect mobility and balance
- Loss of hearing
- For control group
- Communication - Coordination problems of patients
Show all 9Show fewer
- Using medicine which is increasing the risk of fall
- Any neurologic, musculoskeletal or respiratory disorders which affect mobility and balance
- Loss of hearing
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Investigation of Vestibular System Influence in Individuals With Chronic Obstructive Pulmonary Disease
. The main question is whether the vestibular system is affected by COPD. If there is an influence, the second question is what is the relationship between balance and vestibular interaction in COPD patients. A total of 10 COPD patients and 10 healthy adults will include the study. Respiratory functions, vestibular functions and postural stability of participants will be assessed. This research is planned to be carried out as a cross-sectional/descriptive research. It's planned as a pilot study. Comparisons between study and control groups will be made with independent samples t-test for parametric values and Mann Whitney U for non-parametric values.
Read the detailed description
Chronic Obstructive Pulmonary Disorder (COPD) is a common preventable and treatable disease that is characterized by persistent airflow limitation that is usually progressive and associated with an enhanced chronic inflammatory response in the airways and the lung to noxious particles or gases. Hypoxia caused by restrictive airflow is one of the symptoms of COPD. Hypoxia can affect the inner ear and vestibular nuclei. Also, balance impairment can be caused by hypoxia. Previous studies show that balance affected negatively in COPD patients. The aim of this study is to investigate of vestibular system influence in individuals with COPD. A total of 10 COPD patients and 10 healthy adults will include the study. This research is planned to be carried out as a cross-sectional/descriptive research. It's planned as a pilot study. Respiratory functions (respiratory function test), vestibular functions (head shake test, head trust test, unterberger test) and postural stability (sensory organization test) of participants will be assessed.Comparisons between study and control groups will be made with independent samples t-test for parametric values and Mann Whitney U for non-parametric values.
- Conditions
- Vestibular Disorder
- Being tested
- Respiratory Assessment, Vestibular Assessment, Balance Assessment
- Keywords
- vestibular dysfunction, COPD, balance
- Medical subject headings
- Vestibular Diseases, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Respiratory AssessmentOther
Also called Respiratory Function Test
Spirometric measurement
Vestibular AssessmentOther
Also called Head shake test, Head trust test, Unterberger test
Assessment of peripheral vestibular dysfunction, angular vestibule ocular reflex, vestibular dysfunction
Balance AssessmentOther
Also called Sensory organization test
Postural stability
| Study group | Role | What they receive |
|---|---|---|
| COPD Group | Patients who are over 40 years old, diagnosed with COPD Receives: Other: Respiratory Assessment; Other: Vestibular Assessment; Other: Balance Assessment | |
| Control Group | Healthy adults over 40 years old Receives: Other: Respiratory Assessment; Other: Vestibular Assessment; Other: Balance Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vestibular Assessment 1
Head Shake Test:The head shake test is performed by shaking the head of the patient. The head is rotated at a comfortable range at a frequency of about 2 to 3 Hertz for 10- to 15 seconds. After shaking, the head remains in the center and the eyes of the patient are observed for nystagmus. The head shake test is used to look for signs of dynamic imbalance of vestibular function by evaluating the post-shaking nystagmus.
Measured: After the individuals permission, in first 4 minutes
Balance Assessment
Subjects stands on dual force plates and and their anterior posterior sway recorded in different test conditions.
- Eyes open- stable support
- Eyes closed- stable support
- Eyes open- stable support
- Eyes open-Foam surface
- Eyes closed-Foam surface
- Eyes open-Foam surface
Measured: After the individuals permission, in first 20 minutes
Respiratory Assessment - Spirometry - Forced expiratory volume in 1 s (FEV1)
*We will supply the information of test results from patients' folders.*
Forced expiratory volume in 1 s (FEV1)
Spirometry is the term given to the basic lung function -volume, time and flow- tests that measure the air that is expired and inspired. Spirometry is objective and noninvasive.
Before performing the forced expiration, tidal (normal) breaths can be taken first, then a deep breath taken in while still using the mouthpiece, followed by a further quick, full inspiration.
Measured: After the individuals permission, in first 22 minutes
Respiratory Assessment - Spirometry - Forced vital capacity (FVC)
*We will supply the information of test results from patients' folders.*
FVC, the maximum amount of air that can be exhaled when blowing out as fast as possible
Spirometry is the term given to the basic lung function -volume, time and flow- tests that measure the air that is expired and inspired. Spirometry is objective and noninvasive.
Before performing the forced expiration, tidal (normal) breaths can be taken first, then a deep breath taken in while still using the mouthpiece, followed by a further quick, full inspiration.
Measured: After the individuals permission, in first 22 minutes
Respiratory Assessment - Spirometry - Vital capacity (VC)
*We will supply the information of test results from patients' folders.*
Vital capacity (VC), the maximum amount of air that can be exhaled when blowing out as fast as possible
Spirometry is the term given to the basic lung function -volume, time and flow- tests that measure the air that is expired and inspired. Spirometry is objective and noninvasive.
Before performing the forced expiration, tidal (normal) breaths can be taken first, then a deep breath taken in while still using the mouthpiece, followed by a further quick, full inspiration.
Measured: After the individuals permission, in first 22 minutes
Respiratory Assessment - Spirometry - Peak expiratory flow (PEF)
*We will supply the information of test results from patients' folders.*
Peak expiratory flow (PEF), the maximal flow that can be exhaled when blowing out at a steady rate
Spirometry is the term given to the basic lung function -volume, time and flow- tests that measure the air that is expired and inspired. Spirometry is objective and noninvasive.
Before performing the forced expiration, tidal (normal) breaths can be taken first, then a deep breath taken in while still using the mouthpiece, followed by a further quick, full inspiration.
Measured: After the individuals permission, in first 22 minutes
Respiratory Assessment - Spirometry - Forced expiratory flow (FEF)
*We will supply the information of test results from patients' folders.*
Forced expiratory flow, also known as mid-expiratory flow; the rates at 25%, 50% and 75% FVC are given
Spirometry is the term given to the basic lung function -volume, time and flow- tests that measure the air that is expired and inspired. Spirometry is objective and noninvasive.
Before performing the forced expiration, tidal (normal) breaths can be taken first, then a deep breath taken in while still using the mouthpiece, followed by a further quick, full inspiration.
Measured: After the individuals permission, in first 22 minutes
Respiratory Assessment - Spirometry - •Inspiratory vital capacity (IVC)
*We will supply the information of test results from patients' folders.*
Inspiratory vital capacity (IVC), the maximum amount of air that can be inhaled after a full expiration
Spirometry is the term given to the basic lung function -volume, time and flow- tests that measure the air that is expired and inspired. Spirometry is objective and noninvasive.
Before performing the forced expiration, tidal (normal) breaths can be taken first, then a deep breath taken in while still using the mouthpiece, followed by a further quick, full inspiration.
Measured: After the individuals permission, in first 22 minutes
Vestibular Assessment 2
Head Trust Test: A brief, high-acceleration head thrust can test vestibular function of all semicircular canals. Depending on the semicircular canal tested, the head is rotated in a different direction. A corrective catch-up saccade is made in case of vestibular hypofunction.
Measured: After the individuals permission, in first 8 minutes
Vestibular Assessment 3
Unterberger test: Subjects will close their eyes and begin stepping in place for 60 seconds with shoulder at 90 degrees flexion, arms extended forward. The distance will be measured from the start point to end point.
Measured: After the individuals permission, in first 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2020
- Study start25 Feb 2024 (estimated)
- Primary completion15 May 2024 (estimated)
- Study completion15 Jun 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.
- 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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nimet Sermenli Aydın
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Nimet Sermenli Aydın, Trakya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04280211
- Sponsor's protocol ID
- 061
- Status last verified
- Dec 2022
- First submitted
- 6 Feb 2020
- Last updated
- 2 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Vestibular System Influence in Individuals With Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT04280211
- Acronym / sponsor ID
- 061
- Conditions
- Vestibular Disorder
- Keywords
- vestibular dysfunction, COPD, balance
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Nimet Sermenli AydınUniversity, hospital or other
- Study start
- 25 Feb 2024 (estimated)
- Primary completion
- 15 May 2024 (estimated)
- Study completion
- 15 Jun 2024 (estimated)
- First posted
- 21 Feb 2020 (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 main question is whether the vestibular system is affected by COPD. If there is an influence, the second question is what is the relationship between balance and vestibular interaction in COPD patients. A total of 10 COPD patients and 10 healthy adults will include the study. Respiratory functions, vestibular functions and postural stability of participants will be assessed. This research is planned to be carried out as a cross-sectional/descriptive research. It's planned as a pilot study. Comparisons between study and control groups will be made with independent samples t-test for parametric values and Mann Whitney U for non-parametric values.
Detailed description
Chronic Obstructive Pulmonary Disorder (COPD) is a common preventable and treatable disease that is characterized by persistent airflow limitation that is usually progressive and associated with an enhanced chronic inflammatory response in the airways and the lung to noxious particles or gases. Hypoxia caused by restrictive airflow is one of the symptoms of COPD. Hypoxia can affect the inner ear and vestibular nuclei. Also, balance impairment can be caused by hypoxia. Previous studies show that balance affected negatively in COPD patients. The aim of this study is to investigate of vestibular system influence in individuals with COPD. A total of 10 COPD patients and 10 healthy adults will include the study. This research is planned to be carried out as a cross-sectional/descriptive research. It's planned as a pilot study. Respiratory functions (respiratory function test), vestibular functions (head shake test, head trust test, unterberger test) and postural stability (sensory organization test) of participants will be assessed.Comparisons between study and control groups will be made with independent samples t-test for parametric values and Mann Whitney U for non-parametric values.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| COPD Group | – | Other: Respiratory Assessment, Other: Vestibular Assessment, Other: Balance AssessmentPatients who are over 40 years old, diagnosed with COPD |
| Control Group | – | Other: Respiratory Assessment, Other: Vestibular Assessment, Other: Balance AssessmentHealthy adults over 40 years old |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study group will be selected from Respiratory Disease Hospital - (Süreyyapaşa Göğüs Hastalıkları ve Göğüs Cerrahisi Eğitim ve Araştırma Hastanesi) The control group will be invited from the community by announcements.
Key inclusion criteria (3 listed)
- Volunteering to participate in the study
- Diagnosed with COPD
- Volunteering to participate in the study
Key exclusion criteria (9 listed)
- Communication - Coordination problems of patients
- Using medicine which is increasing the risk of fall
- Any neurologic or musculoskeletal disorders which affect mobility and balance
- Loss of hearing
- For control group
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 |
|---|---|---|
| Respiratory AssessmentAlso: Respiratory Function TestSpirometric measurement | Other | COPD Group, Control Group |
| Vestibular AssessmentAlso: Head shake test, Head trust test, Unterberger testAssessment of peripheral vestibular dysfunction, angular vestibule ocular reflex, vestibular dysfunction | Other | COPD Group, Control Group |
| Balance AssessmentAlso: Sensory organization testPostural stability | Other | COPD Group, Control Group |
Primary outcome
Vestibular Assessment 1
Time frame: After the individuals permission, in first 4 minutes
Head Shake Test:The head shake test is performed by shaking the head of the patient. The head is rotated at a comfortable range at a frequency of about 2 to 3 Hertz for 10- to 15 seconds. After shaking, the head remains in the center and the eyes of the patient are observed for nystagmus. The head shake test is used to look for signs of dynamic imbalance of vestibular function by evaluating the post-shaking nystagmus.
Balance Assessment
Time frame: After the individuals permission, in first 20 minutes
Subjects stands on dual force plates and and their anterior posterior sway recorded in different test conditions. 1. Eyes open- stable support 2. Eyes closed- stable support 3. Eyes open- stable support 4. Eyes open-Foam surface 5. Eyes closed-Foam surface 6. Eyes open-Foam surface
Respiratory Assessment - Spirometry - Forced expiratory volume in 1 s (FEV1)
Time frame: After the individuals permission, in first 22 minutes
*We will supply the information of test results from patients' folders.* Forced expiratory volume in 1 s (FEV1) Spirometry is the term given to the basic lung function -volume, time and flow- tests that measure the air that is expired and inspired. Spirometry is objective and noninvasive. Before performing the forced expiration, tidal (normal) breaths can be taken first, then a deep breath taken in while still using the mouthpiece, followed by a further quick, full inspiration.
Respiratory Assessment - Spirometry - Forced vital capacity (FVC)
Time frame: After the individuals permission, in first 22 minutes
*We will supply the information of test results from patients' folders.* FVC, the maximum amount of air that can be exhaled when blowing out as fast as possible Spirometry is the term given to the basic lung function -volume, time and flow- tests that measure the air that is expired and inspired. Spirometry is objective and noninvasive. Before performing the forced expiration, tidal (normal) breaths can be taken first, then a deep breath taken in while still using the mouthpiece, followed by a further quick, full inspiration.
Respiratory Assessment - Spirometry - Vital capacity (VC)
Time frame: After the individuals permission, in first 22 minutes
*We will supply the information of test results from patients' folders.* Vital capacity (VC), the maximum amount of air that can be exhaled when blowing out as fast as possible Spirometry is the term given to the basic lung function -volume, time and flow- tests that measure the air that is expired and inspired. Spirometry is objective and noninvasive. Before performing the forced expiration, tidal (normal) breaths can be taken first, then a deep breath taken in while still using the mouthpiece, followed by a further quick, full inspiration.
Respiratory Assessment - Spirometry - Peak expiratory flow (PEF)
Time frame: After the individuals permission, in first 22 minutes
*We will supply the information of test results from patients' folders.* Peak expiratory flow (PEF), the maximal flow that can be exhaled when blowing out at a steady rate Spirometry is the term given to the basic lung function -volume, time and flow- tests that measure the air that is expired and inspired. Spirometry is objective and noninvasive. Before performing the forced expiration, tidal (normal) breaths can be taken first, then a deep breath taken in while still using the mouthpiece, followed by a further quick, full inspiration.
Respiratory Assessment - Spirometry - Forced expiratory flow (FEF)
Time frame: After the individuals permission, in first 22 minutes
*We will supply the information of test results from patients' folders.* Forced expiratory flow, also known as mid-expiratory flow; the rates at 25%, 50% and 75% FVC are given Spirometry is the term given to the basic lung function -volume, time and flow- tests that measure the air that is expired and inspired. Spirometry is objective and noninvasive. Before performing the forced expiration, tidal (normal) breaths can be taken first, then a deep breath taken in while still using the mouthpiece, followed by a further quick, full inspiration.
Respiratory Assessment - Spirometry - •Inspiratory vital capacity (IVC)
Time frame: After the individuals permission, in first 22 minutes
*We will supply the information of test results from patients' folders.* Inspiratory vital capacity (IVC), the maximum amount of air that can be inhaled after a full expiration Spirometry is the term given to the basic lung function -volume, time and flow- tests that measure the air that is expired and inspired. Spirometry is objective and noninvasive. Before performing the forced expiration, tidal (normal) breaths can be taken first, then a deep breath taken in while still using the mouthpiece, followed by a further quick, full inspiration.
Vestibular Assessment 2
Time frame: After the individuals permission, in first 8 minutes
Head Trust Test: A brief, high-acceleration head thrust can test vestibular function of all semicircular canals. Depending on the semicircular canal tested, the head is rotated in a different direction. A corrective catch-up saccade is made in case of vestibular hypofunction.
Vestibular Assessment 3
Time frame: After the individuals permission, in first 10 minutes
Unterberger test: Subjects will close their eyes and begin stepping in place for 60 seconds with shoulder at 90 degrees flexion, arms extended forward. The distance will be measured from the start point to end point.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2022.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Vestibular Disorder, run by Nimet Sermenli Aydın.
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 3 inclusion and 9 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 2 Dec 2022. 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?
Contact Nimet Sermenli Aydın, MSc (+905079955111, nimetsermenli@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vestibular Assessment 1 (time frame: After the individuals permission, in first 4 minutes). The study lists 10 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 2 Dec 2022.