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Recruiting Observational

Interoception and Symptom Perception in Acute COPD Exacerbation

NCT07719231 · tracked via the Priya Life Science Turkey tracker
Phase
Observational
Started
2026-07-20
Last updated
2026-09-17

Condition(s) studied

Acute Exacerbation of Chronic Obstructive Pulmonary DiseaseInteroceptive Awareness

Investigational drug(s) / intervention(s)

No Intervention: Observational Cohort

No Intervention: Observational Cohort: Participants' sleep quality, COPD symptom burden, dyspnea severity, anxiety and depression levels, and interoceptive processing will be assessed cross-sectionally.

Study summary

Interoception refers to the process of perceiving and interpreting internal physiological signals and plays a central role in symptom perception. In conditions with a high symptom burden such as chronic obstructive pulmonary disease (COPD), clinical features including dyspnea perception, depression, and sleep quality may be influenced not only by disease severity but also by the interpretation of internal bodily signals.

Recent evidence suggests that respiratory-related internal signals are transmitted to the central nervous system through multiple afferent pathways and integrated within cortical and subcortical networks, contributing to subjective experiences such as dyspnea. In this context, dyspnea perception may arise from the interaction between disease severity and interoceptive processes.

Depressive symptoms and impaired sleep quality are also closely associated with interoceptive processes and may contribute to the perception of respiratory symptoms. However, studies simultaneously examining interoception, disease severity, dyspnea perception, depression, and sleep quality in hospitalized patients with acute COPD exacerbation are limited.

This prospective, observational, cross-sectional study will include 50 individuals aged 40 years and older who are hospitalized with acute COPD exacerbation in a Chest Diseases clinic. Data will be collected at a single time point when patients are clinically stable, without interfering with routine clinical care. Participants will be recruited using a consecutive sampling method.

Sociodemographic and clinical data will be obtained from patient records and a structured data collection form. Disease severity will be assessed using oxygen requirement, respiratory rate, oxygen saturation, and arterial blood gas values when available. Interoception will be evaluated using the Multidimensional Assessment of Interoceptive Awareness (MAIA-2). Symptom burden will be assessed with the COPD Assessment Test (CAT), dyspnea with the Modified Medical Research Council (mMRC) scale, sleep quality with the Richards-Campbell Sleep Questionnaire (RCSQ), and depressive symptoms with the Hospital Anxiety and Depression Scale - Depression subscale (HADS-D).

Statistical analyses will be performed using IBM SPSS Statistics software. Relationships between variables will be analyzed using Pearson or Spearman correlation depending on data distribution, with a significance level of p\<0.05.

Eligibility

Sex
ALL
Min age
40 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: * Physician-confirmed diagnosis of acute exacerbation of COPD with hospitalization * Age 40 years or older * Conscious and able to communicate * Willing to participate and provide written informed consent Exclusion Criteria: * Presence of delirium or severe cognitive impairment * Requirement for invasive mechanical ventilation * Clinical instability preventing safe administration of assessment tools * History of severe neurological or psychiatric disorders * Any history of malignancy * Presence of pneumonia * History of stroke

Primary outcome measure(s)

  • Interoception Assessment — baseline
    Interoception will be assessed using the Multidimensional Assessment of Interoceptive Awareness (MAIA), a validated self-report questionnaire that evaluates multiple dimensions of interoceptive processing, including awareness of bodily sensations, emotional and attentional responses to these sensations, and self-regulation abilities; the MAIA consists of several subscales scored on a Likert-type scale (typically 0-5), with higher scores indicating greater interoceptive awareness in the corresponding domain.
  • COPD Symptom Burden Assessment — baseline
    COPD symptom burden will be assessed using the COPD Assessment Test (CAT), an 8-item patient-reported questionnaire; each item is scored on a 6-point Likert scale (0-5), yielding a total score ranging from 0 to 40, with higher scores indicating greater symptom burden and disease impact.
  • Dyspnea Severity Assessment — baseline
    Dyspnea severity will be assessed using the Modified Medical Research Council (mMRC) scale, a widely used grading system that classifies breathlessness from grade 0 to 4 based on activity limitation, with higher scores indicating more severe dyspnea.
  • Sleep Quality Assessment — baseline
    Sleep quality will be assessed using the Richard-Campbell Sleep Questionnaire (RCSQ), a patient-reported instrument evaluating perceived sleep depth, sleep latency, number of awakenings, sleep efficiency, and overall sleep quality; each item is rated on a visual analog scale (0-100), with higher scores indicating better perceived sleep quality.
  • Anxiety and Depression Assessment — baseline
    Anxiety and depression will be assessed separately using the Hospital Anxiety and Depression Scale (HADS), which consists of two subscales-HADS-Anxiety (HADS-A) and HADS-Depression (HADS-D)-each including 7 items scored from 0 to 3, yielding subscale scores ranging from 0 to 21, with higher scores indicating greater symptom severity.

Trial sites (1)

FacilityCityRegionStatus
Goztepe Prof Dr Suleyman Yalcin City Hospital Istanbul Turkey (Türkiye) Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07719231 on ClinicalTrials.gov ↗ ← All trials in Turkey