Cognitive Load and Inhaler Technique in COPD

NCT07786220 | Recruiting

• 1 other identifier: COPD-DT-INHALER-2026-01
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

COPD

Keywords

Chronic Obstructive Pulmonary Disease; Inhaler Technique; Cognitive Load; Dual-Task Performance; Timed Up and Go

Outcome Measures

Primary Outcomes (1)

• Change in Inhaler Technique Performance Under Cognitive Load

  Difference in the number of satisfactory inhaler-technique steps between the cognitive dual-task condition and the single-task condition, assessed using the same standardized 5-item device-specific inhaler technique checklist. Each checklist item is scored as 1 = satisfactory or 0 = unsatisfactory/omitted, yielding a total score of 0 to 5 for each condition. The primary outcome is calculated as dual-task satisfactory score minus single-task satisfactory score, with a possible range from -5 to +5. Negative values indicate deterioration of inhaler technique under cognitive load.

  During the single study visit, immediately after completion of both inhaler conditions

Secondary Outcomes (7)

• New Inhaler Error Under Cognitive Load

  During the single study visit, immediately after completion of both inhaler conditions

• Worsening of Inhaler Technique Classification Under Cognitive Load

  During the single study visit, immediately after completion of both inhaler conditions

• Inhaler Time Dual-Task Cost

  During the single study visit, immediately after completion of both inhaler conditions

• Inhaler Cognitive Dual-Task Cost

  During the single study visit, immediately after completion of the inhaler cognitive assessments

• Physical Dual-Task Cost During Timed Up and Go

  During the single study visit, immediately after completion of the single-task and dual-task Timed Up and Go assessments

Study Arms (2)

Single-Task Followed by Cognitive Dual-Task

EXPERIMENTAL

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.

Behavioral: Working-Memory Cognitive Load During Inhaler Use; Behavioral: Single-Task Inhaler Use

Cognitive Dual-Task Followed by Single-Task

EXPERIMENTAL

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.

Behavioral: Working-Memory Cognitive Load During Inhaler Use; Behavioral: Single-Task Inhaler Use

Interventions

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.

Cognitive Dual-Task Followed by Single-Task; Single-Task Followed by Cognitive Dual-Task

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.

Cognitive Dual-Task Followed by Single-Task; Single-Task Followed by Cognitive Dual-Task

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Spitalul Clinic de Boli Infecțioase și Pneumoftiziologie Dr. Victor Babeș Timișoara: lead

Study Sites (1)

"Dr. Victor Babeș" Clinical Hospital of Infectious Diseases and Pneumophthisiology, Timișoara

Timișoara, Timiș County, 300041, Romania

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Alexandru Crișan

CONTACT

0765525688; crisan@umft.ro

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer, University Clinic of Medical rehabilitation, "Victor Babeș" University of Medicine and Pharmacy Timișoara

Model Details: Each participant completes both inhaler-use conditions during a single study visit: single-task inhaler use and inhaler use under working-memory cognitive load. The order of the two conditions is assigned according to one of two predefined sequences.

Study Record Dates

• First Submitted: August 21, 2026
• First Posted: August 25, 2026
• Study Start: August 21, 2026
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): November 30, 2027
• Last Updated: August 26, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

RO (1)