NCT07344649

Brief Summary

Dysfunctional breathing is a common and clinically relevant problem in patients with chronic obstructive pulmonary disease (COPD), contributing to increased dyspnea perception, reduced exercise tolerance, and impaired quality of life. The Nijmegen Questionnaire (NQ) is a widely used symptom-based instrument for screening dysfunctional breathing; however, a validated Turkish version for patients with COPD is currently unavailable. This observational methodological study aims to translate, culturally adapt, and evaluate the validity and reliability of the Turkish version of the Nijmegen Questionnaire (NQ-TR) in individuals with stable COPD.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
7mo left

Started Apr 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress24%
Apr 2026Jan 2027

First Submitted

Initial submission to the registry

January 1, 2026

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 15, 2026

Completed
3 months until next milestone

Study Start

First participant enrolled

April 13, 2026

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2027

Last Updated

April 15, 2026

Status Verified

April 1, 2026

Enrollment Period

9 months

First QC Date

January 1, 2026

Last Update Submit

April 13, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Turkish version of the Nijmegen Questionnaire (NQ-TR)

    The Nijmegen Questionnaire is a validated self-report instrument used to assess symptoms related to dysfunctional breathing and hyperventilation. It consists of 16 items evaluating the frequency of respiratory and non-respiratory symptoms, with higher total scores indicating greater symptom severity. In this study, the Turkish-validated version of the Nijmegen Questionnaire (NQ-TR) will be used to evaluate dysfunctional breathing symptoms in participants.

    Baseline and 1 week

Secondary Outcomes (4)

  • COPD Assessment Test (CAT)

    Baseline

  • Modified Medical Research Council (mMRC) Dyspnea Scale

    Baseline

  • Dyspnea-12 (D-12) Scale

    Baseline

  • Hospital Anxiety and Depression Scale (HADS)

    Baseline

Study Arms (1)

COPD

Other: Questionnaires

Interventions

Administration of validated self-reported questionnaires (Nijmegen Questionnaire, CAT, mMRC, HADS, Dyspnea-12)

COPD

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The study population consists of adults aged 18 years and older with a confirmed diagnosis of chronic obstructive pulmonary disease (COPD) according to GOLD criteria. Eligible participants are clinically stable patients attending the pulmonology outpatient clinic of a tertiary care hospital, with no acute exacerbation or hospitalization within the previous four weeks. All participants are Turkish-speaking, able to complete self-reported questionnaires, and provide written informed consent.

You may qualify if:

  • Adults aged 18 years and older
  • Diagnosis of COPD confirmed according to GOLD criteria
  • Clinically stable disease (no acute exacerbation or hospitalization within the last 4 weeks)
  • Ability to read and understand Turkish
  • Willingness to participate and provide written informed consent

You may not qualify if:

  • Acute COPD exacerbation or respiratory infection within the previous 4 weeks
  • Presence of severe cardiac, neurological, or systemic disease affecting questionnaire responses
  • Coexisting pulmonary conditions such as bronchiectasis, lung cancer, prior pulmonary tuberculosis, pleural disease, or history of lung surgery
  • Moderate to severe cognitive impairment or communication difficulties
  • Severe visual or hearing impairment preventing questionnaire completion
  • Pregnancy
  • Refusal to participate or withdrawal during the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Esra Pehlivan

Istanbul, 34668, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 1, 2026

First Posted

January 15, 2026

Study Start

April 13, 2026

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

January 1, 2027

Last Updated

April 15, 2026

Record last verified: 2026-04

Locations