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RECRUITING Not applicable ClinicalTrials.gov

Cognitive Load and Inhaler Technique in COPD

Sponsor: Spitalul Clinic de Boli Infecțioase și Pneumoftiziologie Dr. Victor Babeș Timișoara • ClinicalTrials.gov ID: NCT07786220

Registry updated: 2026-08-26
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Description

This study evaluates whether cognitive load affects inhaler technique in adults with chronic obstructive pulmonary disease (COPD). During a single study visit, participants will complete assessments of cognitive function, mobility, and respiratory status. Dual-task mobility will be assessed using the Timed Up and Go test performed alone and while completing a cognitive task. Inhaler technique will then be evaluated in two conditions: usual inhaler use without an additional task and inhaler use while maintaining a short sequence of digits in working memory. Inhaler technique will be scored using a standardized five-step device-specific checklist, and inhaler use time will also be recorded. The study will examine whether inhaler technique worsens under cognitive load and whether this deterioration is associated with dual-task mobility performance, cognitive function, respiratory symptoms, and functional capacity. No inhaler training or correction will be provided between the two inhaler conditions. All assessments are performed during a single visit.

Interventions

  • Working-Memory Cognitive Load During Inhaler Use (Behavioral)
    Participants are presented with a standardized five-digit sequence before inhaler use and are instructed to retain the sequence in working memory while completing their usual inhaler technique. The sequence is presented once at approximately one digit per second. Participants do not verbalize the digits during inhaler use. Immediately after completing the inhaler maneuver, they reproduce the sequence in reverse order. Inhaler technique is simultaneously assessed using a standardized five-item device-specific checklist, and inhaler-use time is recorded.
  • Single-Task Inhaler Use (Behavioral)
    Participants use their usual maintenance inhaler without a concurrent cognitive task. They are instructed to use the inhaler as they normally do at home. Inhaler technique is assessed using the same standardized five-item device-specific checklist, and inhaler-use time is recorded. No inhaler-technique training, correction, or feedback is provided before completion of both study conditions.

Eligibility criteria

Inclusion Criteria: * Adults aged 18 years or older * Confirmed diagnosis of chronic obstructive pulmonary disease (COPD) * Clinically stable at the time of assessment * Current use of at least one handheld maintenance inhaler (pMDI, SMI, or DPI) * Able to understand and follow study instructions * Able to perform the Timed Up and Go test * Able to complete the cognitive tasks and inhaler technique assessment * Able and willing to provide written informed consent Exclusion Criteria: * Recent COPD exacerbation with incomplete recovery to baseline clinical status * Acute respiratory or other acute medical condition at the time of assessment * Known severe cognitive impairment or dementia that prevents completion of study procedures * Neurological or musculoskeletal impairment that prevents safe completion of the Timed Up and Go test * Severe visual, hearing, or communication impairment that prevents completion of the cognitive or inhaler tasks * Inability to independently handle or use the study inhaler device for assessment purposes

Conditions

COPD

Locations

  • "Dr. Victor Babeș" Clinical Hospital of Infectious Diseases and Pneumophthisiology, Timișoara — Timișoara, Timiș County, Romania
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record