NCT07719231

Brief 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.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
1mo left

Started Jul 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress35%
Jul 2026Aug 2026

First Submitted

Initial submission to the registry

May 6, 2026

Completed
3 months until next milestone

Study Start

First participant enrolled

July 20, 2026

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 22, 2026

Completed
29 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 20, 2026

Expected
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 25, 2026

Last Updated

July 22, 2026

Status Verified

July 1, 2026

Enrollment Period

1 month

First QC Date

May 6, 2026

Last Update Submit

July 17, 2026

Conditions

Keywords

Acute Exacerbation of COPDInteroceptive AwarenessDyspnea PerceptionSleep Quality

Outcome Measures

Primary Outcomes (5)

  • 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.

    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.

    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.

    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.

    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.

    baseline

Study Arms (1)

Acute COPD Exacerbation

Hospitalized Patients With Acute COPD Exacerbation

Other: No Intervention: Observational Cohort

Interventions

Participants' sleep quality, COPD symptom burden, dyspnea severity, anxiety and depression levels, and interoceptive processing will be assessed cross-sectionally.

Acute COPD Exacerbation

Eligibility Criteria

Age40 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Goztepe Prof Dr Suleyman Yalcin City Hospital

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Study Officials

  • Gamze Koyutürk, Asst Prof

    Topkapı University

    PRINCIPAL INVESTIGATOR
  • Mehmet Burak Uyaroğlu, Asst Prof

    Fenerbahce University

    STUDY DIRECTOR
  • Hüsna Güzel

    Fenerbahce University

    STUDY CHAIR
  • Yiğit Ege Güney

    Topkapı University

    STUDY CHAIR
  • Esra Ertan Yazar, Prof Dr

    Medeniyet University

    STUDY CHAIR

Central Study Contacts

Gamze Koyutürk, PhD

CONTACT

Mehmet Burak Uyaroğlu, Asst Prof

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

May 6, 2026

First Posted

July 22, 2026

Study Start

July 20, 2026

Primary Completion (Estimated)

August 20, 2026

Study Completion (Estimated)

August 25, 2026

Last Updated

July 22, 2026

Record last verified: 2026-07

Locations