Hyperventilation SyndromeNCT04254952
Turkish Version of Nijmegen Questionnaire
An observational study of Hyperventilation Syndrome, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
The study aims to provide Turkish version of Nijmegen Questionnaire for the evaluation of respiratory dysfunction in asthmatic subjects. The incidence of hyperventilation syndrome in asthmatic patients can be determined with the results of the study. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hyperventilation Syndrome
- How many people
- 54 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Sep 2019to 21 Feb 2021
- 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 18 to 75 years
- All sexes
- Adult, Older adult
Study population: Asthmatic patients
Who may be able to join
- Having mild to moderate clinically stable asthmatic patients
- Being able to cooperate
- Being 18 years old or older
Who cannot join
- Having severe orthopedic, neurological, cardiovascular disorders or cognitive problems
- Unable to cooperte
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Validity and Reliability of the Turkish Version of the Nijmegen Questionnaire in Evaluating Respiratory Dysfunction in Asthmatic Patients
The study aims to provide Turkish version of Nijmegen Questionnaire for the evaluation of respiratory dysfunction in asthmatic subjects. The incidence of hyperventilation syndrome in asthmatic patients can be determined with the results of the study.
Read the detailed description
Nijmegen Questionnaire allows to assess and identify respiratory symptoms and dysfunction, and to assess unexplained respiratory symptoms and symptoms of hyperventilation syndrome. Determining whether Turkish version of Nijmegen Questionnaire is a valid and reliable tool in asthmatic individuals will guide researchers for further studies on identifying appropriate treatment approaches for the patient and developing different treatment strategies. Hyperventilation syndrome is a recognized form of respiratory dysfunction associated with biochemical factors. Hyperventilation syndrome is defined as breathing above the body's metabolic requirements. This results in decreased carbon dioxide pressure in the arterial blood, respiratory alkalosis, and increased symptoms. Complex symptoms such as shortness of breath, chest tightness, paresthesia, anxiety, and dizziness may occur. There is no laboratory test which is the gold standard in the diagnosis of hyperventilation syndrome. If it is concluded that the Turkish version of the Nijmegen Questionnaire is a valid and reliable test in individuals with asthma, a new tool will be introduced to the literature for the evaluation of pulmonary dysfunction in asthmatic individuals.
- Conditions
- Hyperventilation Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
Dyspnea perception
Dyspnea will be evaluated with a modified Borg scale. The modified Borg scale is a category scale that evaluates dyspnea between the scores of 0-10. Patients will be asked to mark the appropriate value on the scale.
Measured: 1st day
Breathe-holding time
Individuals are asked to hold their breaths in the sitting position by closing their nostrils and in functional residual volume (after a normal exhalation). In order to eliminate the learning effect, the measurement is repeated three times and the averages of the times are recorded in seconds.
Measured: 1st day
End-tidal CO2 measurement
A portable capnograph with a nasal cannula will be used for the measurement of mean ETCO2 and resting respiration rate over a ten-minute period. Individuals will be asked to breathe through the nose and not speak during the measurement.
Measured: 1st day
Asthma control test
Test is used to evaluate asthma control. The questionnaire consists of five items. The total test score ranges from 5 (weak control) to 25 (fully controlled) (14). A total score of <20 indicates uncontrollable asthma.
Measured: 1st day
Nijmegen Questionnaire
The Nijmegen Questionnaire has been validated as a screening tool for the detection of hyperventilation syndrome (HVS), consisting 16 items. A score of over 23 out of 64 suggests a positive diagnosis of HVS. It has also been used to detect dysfunctional breathing in patients with asthma.
Measured: 1st day
Secondary outcomes (3)
Quality of life questionnaire
The overall quality of life will be determined by the Nottingham Health Profile (NHP). The NHP consists of 38 substances that the individual can complete without the need for a person. The questionnaire has six sub scales: energy (3 items), pain (8 items), emotional reactions (9 items), sleep (5 items), social isolation (5 items) and physical mobility (8 items). For each subsection there is a possible range of points ranging from 0-100 points. Higher scores indicate more limitations in quality of life.
Measured: 1st day
Disease-specific quality of life
Disease-specific quality of life will be determined by the Asthma Quality of Life Questionnaire (AQLQ). The Asthma Quality of Life Questionnaire was found to be valid and reliable in Turkish. The quality of life questionnaire in individuals with asthma is a 32-item disease-specific questionnaire in four health domains, including activity limitation (11 items), symptoms (12 items), emotional function (5 items), and environmental stimuli (4 items). Scores range 1-7, with higher scores indicating better quality of life.
Measured: 1st day
Assessment of anxiety and depression
The Beck Depression Inventory (BDI) measures physical, emotional, cognitive, and motivational symptoms of depression. The aim of the scale is to determine the level of depression symptoms and the change in severity. BDI is a scale that includes 21 self-assessment sentences and there are four options in each symptom category. Each item is scored between 0-3 points and the total score varies between 0 and 63. The validity and reliability study of the scale was conducted in Turkish. The cut-off value of the Turkish form was determined to be 17.
Measured: 1st day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start15 Sep 2019
- Primary completion21 Feb 2021
- Study completion21 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hyperventilation SyndromeStudies 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 only
- Time perspective
- Prospective
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aslihan Cakmak, Hacettepe University
- Investigators
- Deniz Inal-Ince, Prof, Study director, Hacettepe UniversityGul Karakaya, Prof, Principal investigator, Hacettepe UniversityAslihan Cakmak, MSc, Principal investigator, Hacettepe UniversitySenem Simsek, MSc, Principal investigator, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04254952
- Sponsor's protocol ID
- GO 20/199
- Status last verified
- May 2021
- First submitted
- 15 Oct 2019
- Last updated
- 25 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Validity and Reliability of the Turkish Version of the Nijmegen Questionnaire in Evaluating Respiratory Dysfunction in Asthmatic Patients
- ClinicalTrials.gov ID
- NCT04254952
- Acronym / sponsor ID
- GO 20/199
- Conditions
- Hyperventilation Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 15 Sep 2019 (actual)
- Primary completion
- 21 Feb 2021 (actual)
- Study completion
- 21 Feb 2021 (actual)
- First posted
- 5 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 study aims to provide Turkish version of Nijmegen Questionnaire for the evaluation of respiratory dysfunction in asthmatic subjects. The incidence of hyperventilation syndrome in asthmatic patients can be determined with the results of the study.
Detailed description
Nijmegen Questionnaire allows to assess and identify respiratory symptoms and dysfunction, and to assess unexplained respiratory symptoms and symptoms of hyperventilation syndrome. Determining whether Turkish version of Nijmegen Questionnaire is a valid and reliable tool in asthmatic individuals will guide researchers for further studies on identifying appropriate treatment approaches for the patient and developing different treatment strategies. Hyperventilation syndrome is a recognized form of respiratory dysfunction associated with biochemical factors. Hyperventilation syndrome is defined as breathing above the body's metabolic requirements. This results in decreased carbon dioxide pressure in the arterial blood, respiratory alkalosis, and increased symptoms. Complex symptoms such as shortness of breath, chest tightness, paresthesia, anxiety, and dizziness may occur. There is no laboratory test which is the gold standard in the diagnosis of hyperventilation syndrome. If it is concluded that the Turkish version of the Nijmegen Questionnaire is a valid and reliable test in individuals with asthma, a new tool will be introduced to the literature for the evaluation of pulmonary dysfunction in asthmatic individuals.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Asthmatic patients
Key inclusion criteria (3 listed)
- Having mild to moderate clinically stable asthmatic patients
- Being able to cooperate
- Being 18 years old or older
Key exclusion criteria (2 listed)
- Having severe orthopedic, neurological, cardiovascular disorders or cognitive problems
- Unable to cooperte
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
Dyspnea perception
Time frame: 1st day
Dyspnea will be evaluated with a modified Borg scale. The modified Borg scale is a category scale that evaluates dyspnea between the scores of 0-10. Patients will be asked to mark the appropriate value on the scale.
Breathe-holding time
Time frame: 1st day
Individuals are asked to hold their breaths in the sitting position by closing their nostrils and in functional residual volume (after a normal exhalation). In order to eliminate the learning effect, the measurement is repeated three times and the averages of the times are recorded in seconds.
End-tidal CO2 measurement
Time frame: 1st day
A portable capnograph with a nasal cannula will be used for the measurement of mean ETCO2 and resting respiration rate over a ten-minute period. Individuals will be asked to breathe through the nose and not speak during the measurement.
Asthma control test
Time frame: 1st day
Test is used to evaluate asthma control. The questionnaire consists of five items. The total test score ranges from 5 (weak control) to 25 (fully controlled) (14). A total score of <20 indicates uncontrollable asthma.
Nijmegen Questionnaire
Time frame: 1st day
The Nijmegen Questionnaire has been validated as a screening tool for the detection of hyperventilation syndrome (HVS), consisting 16 items. A score of over 23 out of 64 suggests a positive diagnosis of HVS. It has also been used to detect dysfunctional breathing in patients with asthma.
3 secondary outcomes
Quality of life questionnaire
Time frame: 1st day
Disease-specific quality of life
Time frame: 1st day
Assessment of anxiety and depression
Time frame: 1st day
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 25 May 2021.
- Individual participant dataSharing planned: No
Related trials for Hyperventilation Syndrome
Not yet recruitingObservational study
Symptomatic Hyperventilation in Individuals Living With Stroke
Stroke, Hyperventilation Syndrome
RecruitingObservational study
Dysfunctional Breathing in Post COVID-19 Condition.
Post COVID-19 Condition (PCC), Dysfunctional Breathing
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.
Deniz Inal-Ince, Prof study director
Hacettepe University
Gul Karakaya, Prof principal investigator
Hacettepe University
Aslihan Cakmak, MSc principal investigator
Hacettepe University
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 Hyperventilation Syndrome, run by Hacettepe 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 3 inclusion and 2 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 25 May 2021. 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?
Dyspnea perception (time frame: 1st day). The study lists 5 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 25 May 2021.