Cognitive Load and Inhaler Technique in COPD

Sponsor
Spitalul Clinic de Boli Infecțioase și Pneumoftiziologie Dr. Victor Babeș Timișoara
Study ID
NCT07786220
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 100 Years
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

First listed
Aug 25, 2026
Start date
Aug 21, 2026
Status verified
Aug 2026
Primary completion
Sep 30, 2027
Completion
Nov 30, 2027

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER

Arms

  • Experimental: Single-Task Followed by Cognitive Dual-Task
    Participants first perform inhaler use under the single-task condition, without a concurrent cognitive task. After a short rest and without any inhaler-technique training or correction, they perform inhaler use under a working-memory cognitive load. In both conditions, inhaler technique is scored using the same standardized five-item device-specific checklist and inhaler-use time is recorded.
  • Experimental: Cognitive Dual-Task Followed by Single-Task
    Participants first perform inhaler use under a working-memory cognitive load. After a short rest and without any inhaler-technique training or correction, they perform inhaler use under the single-task condition without a concurrent cognitive task. In both conditions, inhaler technique is scored using the same standardized five-item device-specific checklist and inhaler-use time is recorded.

Primary Outcome Measure

Change in Inhaler Technique Performance Under Cognitive Load [ Time Frame: During the single study visit, immediately after completion of both inhaler conditions ]

Central Contacts

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