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CompletedNCT04254952Updated May 25, 2021

Turkish Version of Nijmegen Questionnaire

An observational study in Hyperventilation Syndrome, sponsored by Hacettepe University. Completed at 1 site in Turkey. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2021-05-25.

Sponsored by Hacettepe University · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
54
Ages
18 Years to 75 Years
Sex
All
01

Study 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 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.

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Conditions studied

  • Hyperventilation Syndrome

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03

In context

Hyperventilation

43 studies on the registry are indexed under Hyperventilation; 6 are open to participants now.

This study's enrollment of 54 is close to the median of 54 across 11 observational studies indexed under Hyperventilation.

Browse Hyperventilation studies →

Lead sponsor

Hacettepe University is the lead sponsor of 1,007 studies on the registry; 214 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Sampling method
Probability sample

Study population

Asthmatic patients

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Having mild to moderate clinically stable asthmatic patients
  • Being able to cooperate
  • Being 18 years old or older

Exclusion criteria

Exclusion Criteria:

  • Having severe orthopedic, neurological, cardiovascular disorders or cognitive problems
  • Unable to cooperte
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Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
54 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 1st day

  2. 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.

    Time frame: 1st day

  3. 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.

    Time frame: 1st day

  4. 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.

    Time frame: 1st day

  5. 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.

    Time frame: 1st day

Secondary outcomes

  1. 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.

    Time frame: 1st day

  2. 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.

    Time frame: 1st day

  3. 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.

    Time frame: 1st day

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Study locations

1 site
  • Aslihan Cakmak
    Ankara, 06100, Turkey
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 25, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04254952
Responsible party
Aslihan Cakmak (Research Assistant, Hacettepe University) — Principal investigator
First posted
Feb 5, 2020
Start date
Sep 15, 2019
Primary completion
Feb 21, 2021
Completion
Feb 21, 2021
Last update
May 25, 2021

Study contacts

Deniz Inal-Ince, Prof
study director · Hacettepe University
Gul Karakaya, Prof
principal investigator · Hacettepe University
Aslihan Cakmak, MSc
principal investigator · Hacettepe University
Senem Simsek, MSc
principal investigator · Hacettepe University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2021. You cannot join it, but the record below documents what was studied.

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