Acute Exacerbation of Chronic Obstructive Pulmonary DiseaseNCT07719231
Interoception and Symptom Perception in Acute COPD Exacerbation
An observational study of Acute Exacerbation of Chronic Obstructive Pulmonary Disease and Interoceptive Awareness, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Acute Exacerbation of Chronic Obstructive Pulmonary Disease, Interoceptive Awareness
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Jul 2026to 1 Nov 2026
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population consists of adults aged 40 years and older who are hospitalized with a physician-confirmed diagnosis of acute exacerbation of chronic obstructive pulmonary disease (COPD) in a Chest Diseases clinic. Participants are recruited using a consecutive sampling method and include individuals who are clinically stable at the time of assessment.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Mehmet Burak Uyaroğlu, Asst Prof contact
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Goztepe Prof Dr Suleyman Yalcin City Hospital
Istanbul
Gamze Koyutürk, Asst. Prof, gamzekoyuturk@topkapi.edu.tr
Mehmet Burak Uyaroglu, Asst Prof
About this study
Official title: 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.
Read more
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.
Read the detailed description
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.
- Being tested
- No Intervention: Observational Cohort
- Keywords
- Acute Exacerbation of COPD, Interoceptive Awareness, Dyspnea Perception, Sleep Quality
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No Intervention: Observational CohortOther
Participants' sleep quality, COPD symptom burden, dyspnea severity, anxiety and depression levels, and interoceptive processing will be assessed cross-sectionally.
| Study group | Role | What they receive |
|---|---|---|
| Acute COPD Exacerbation | Hospitalized Patients With Acute COPD Exacerbation Receives: Other: No Intervention: Observational Cohort |
What is being measured
The primary outcome is the main question the study is designed to answer.
Interoception Assessment
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.
Measured: baseline
COPD Symptom Burden Assessment
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.
Measured: baseline
Dyspnea Severity Assessment
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.
Measured: baseline
Sleep Quality Assessment
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.
Measured: baseline
Anxiety and Depression Assessment
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.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2026
- Study start20 Jul 2026
- Primary completion20 Aug 2026
- Study completion1 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Exacerbation of Chronic Obstructive Pulmonary DiseaseStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gamze Altınkaynak, Saglik Bilimleri Universitesi
- Investigators
- Gamze Koyutürk, Asst Prof, Principal investigator, Topkapı UniversityMehmet Burak Uyaroğlu, Asst Prof, Study director, Fenerbahce UniversityHüsna Güzel, Study chair, Fenerbahce UniversityYiğit Ege Güney, Study chair, Topkapı UniversityEsra Ertan Yazar, Prof Dr, Study chair, Medeniyet University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07719231
- Sponsor's protocol ID
- TopkapiÜni
- Status last verified
- Sep 2026
- First submitted
- 6 May 2026
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Relationship Between Interoception, Disease Severity, Perception of Dyspnea, Depression, and Sleep Quality in Hospitalized Patients With Acute COPD Exacerbation
- ClinicalTrials.gov ID
- NCT07719231
- Acronym / sponsor ID
- TopkapiÜni
- Keywords
- Acute Exacerbation of COPD, Interoceptive Awareness, Dyspnea Perception, Sleep Quality
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Study start
- 20 Jul 2026 (actual)
- Primary completion
- 20 Aug 2026 (actual)
- Study completion
- 1 Nov 2026 (estimated)
- First posted
- 22 Jul 2026 (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.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Acute COPD Exacerbation | – | Other: No Intervention: Observational CohortHospitalized Patients With Acute COPD Exacerbation |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of adults aged 40 years and older who are hospitalized with a physician-confirmed diagnosis of acute exacerbation of chronic obstructive pulmonary disease (COPD) in a Chest Diseases clinic. Participants are recruited using a consecutive sampling method and include individuals who are clinically stable at the time of assessment.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No Intervention: Observational CohortParticipants' sleep quality, COPD symptom burden, dyspnea severity, anxiety and depression levels, and interoceptive processing will be assessed cross-sectionally. | Other | Acute COPD Exacerbation |
Primary outcome
Interoception Assessment
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
- Individual participant dataSharing planned: Undecided
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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.
Mehmet Burak Uyaroğlu, Asst Prof contact
Gamze Koyutürk, Asst Prof principal investigator
Topkapı University
Mehmet Burak Uyaroğlu, Asst Prof study director
Fenerbahce University
Hüsna Güzel study chair
Fenerbahce 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 Acute Exacerbation of Chronic Obstructive Pulmonary Disease and Interoceptive Awareness, run by Saglik Bilimleri Universitesi 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 4 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 17 Sep 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gamze Koyutürk, PhD (+905065798671, gamzealtinkaynak@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Interoception Assessment (time frame: baseline). 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 17 Sep 2026; AzTrials last refreshed its copy on 29 Oct 2026.