- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07719231
Interoception and Symptom Perception in Acute COPD Exacerbation
Investigation of the Relationship Between Interoception, Disease Severity, Perception of Dyspnea, Depression, and Sleep Quality in Hospitalized Patients With Acute COPD Exacerbation
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.
Přehled studie
Postavení
Intervence / Léčba
Detailní popis
Acute exacerbations of chronic obstructive pulmonary disease (AECOPD) represent critical events characterized by a sudden worsening of respiratory symptoms, including dyspnea, cough, and sputum production, often leading to increased healthcare utilization, hospitalization, and mortality. Despite advances in pharmacological and supportive management, considerable heterogeneity exists in how patients perceive and report symptoms during exacerbations. This variability cannot be fully explained by physiological impairment alone and suggests an important role for altered interoceptive processing.
Interoception refers to the sensing, interpretation, and integration of internal bodily signals, including respiratory sensations such as dyspnea, air hunger, and breathing effort. In COPD, especially during acute exacerbations, structural and functional changes in the respiratory system (e.g., airflow limitation, dynamic hyperinflation, and gas exchange abnormalities) interact with central perceptual and cognitive-emotional processes. Consequently, symptom perception is not solely determined by objective physiological parameters but is shaped by interoceptive accuracy, interoceptive sensibility, and interoceptive awareness.
Emerging evidence suggests that patients with COPD may exhibit altered interoceptive processing, leading to either heightened sensitivity (over-perception) or blunted awareness (under-perception) of respiratory symptoms. Under-perception may delay care-seeking behavior and increase the risk of severe exacerbations and adverse outcomes, whereas over-perception may contribute to anxiety, increased symptom burden, and unnecessary healthcare use. However, the mechanisms underlying these differences remain insufficiently understood, particularly in the acute exacerbation setting.
This study aims to investigate the relationship between interoception and symptom perception in patients experiencing AECOPD. Specifically, the study will evaluate how different dimensions of interoception-such as interoceptive accuracy (objective performance in detecting internal signals), interoceptive sensibility (self-reported perception), and metacognitive awareness-are associated with the intensity and variability of respiratory symptoms during exacerbation.
Participants diagnosed with AECOPD will be recruited in a hospital setting. Following eligibility screening and informed consent, participants will undergo a comprehensive assessment protocol. Demographic and clinical data, including age, sex, smoking history, disease severity, comorbidities, and prior exacerbation frequency, will be collected. Clinical status during exacerbation will be documented using standard measures such as symptom scores, vital signs, and, where available, pulmonary function parameters.
Interoceptive processing will be assessed using a multimodal approach. Behavioral tasks designed to quantify interoceptive accuracy (e.g., respiratory-related perception tasks or adapted detection paradigms) will be administered. In parallel, validated self-report instruments will be used to evaluate interoceptive sensibility and awareness, including multidimensional questionnaires capturing attention to bodily sensations, emotional appraisal, and regulatory aspects of interoception. Symptom perception will be quantified using standardized dyspnea scales and patient-reported outcome measures specific to COPD.
The study will also explore the influence of psychological factors, such as severity of symptoms, sleep, anxiety and depression, on the relationship between interoception and symptom perception.
Typ studie
Zápis (Odhadovaný)
Kontakty a umístění
Studijní kontakt
- Jméno: Gamze Koyutürk, PhD
- Telefonní číslo: +905065798671
- E-mail: gamzealtinkaynak@gmail.com
Studijní záloha kontaktů
- Jméno: Mehmet Burak Uyaroglu, Asst Prof
Studijní místa
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Istanbul, Turecko (Türkiye)
- Goztepe Prof Dr Suleyman Yalcin City Hospital
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Kontakt:
- Mehmet Burak Uyaroglu, Asst Prof
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Kontakt:
- Gamze Koyutürk, Asst. Prof
- E-mail: gamzekoyuturk@topkapi.edu.tr
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Metoda odběru vzorků
Studijní populace
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
Kohorty a intervence
Skupina / kohorta |
Intervence / Léčba |
|---|---|
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Acute COPD Exacerbation
Hospitalized Patients With Acute COPD Exacerbation
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Participants' sleep quality, COPD symptom burden, dyspnea severity, anxiety and depression levels, and interoceptive processing will be assessed cross-sectionally.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Interoception Assessment
Časové okno: baseline
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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.
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baseline
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COPD Symptom Burden Assessment
Časové okno: baseline
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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.
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baseline
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Dyspnea Severity Assessment
Časové okno: baseline
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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.
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baseline
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Sleep Quality Assessment
Časové okno: baseline
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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.
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baseline
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Anxiety and Depression Assessment
Časové okno: baseline
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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.
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baseline
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Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Gamze Koyutürk, Asst Prof, Topkapı University
- Ředitel studie: Mehmet Burak Uyaroğlu, Asst Prof, Fenerbahce University
- Studijní židle: Hüsna Güzel, Fenerbahce University
- Studijní židle: Yiğit Ege Güney, Topkapı University
- Studijní židle: Esra Ertan Yazar, Prof Dr, Medeniyet University
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
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