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NCT Number: NCT07786220

Cognitive Load and Inhaler Technique in COPD

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.

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Key information

Conditions

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

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Timișoara, Timiș County, 300041, Romania

Location status: Recruiting

Location contact

Alexandru Crișan

CONTACT

[email protected]

0765525688

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Age ≥18 years. Established diagnosis of chronic obstructive pulmonary disease (COPD). Clinically stable at the time of assessment. Current use of at least one maintenance handheld inhaler (pMDI, SMI, or DPI). Ability to perform the Timed Up and Go test and the study cognitive tasks. Ability to understand the study procedures and provide written informed consent.

Exclusion criteria

Acute COPD exacerbation or incomplete recovery from a recent exacerbation at the time of assessment.

Clinical condition preventing safe completion of the Timed Up and Go test. Inability to complete the cognitive or inhaler assessment procedures required by the protocol.

Inability to provide informed consent.

Treatment and study plan

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.

Primary outcomes

  1. Change in Inhaler Technique Performance Under Cognitive Load

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

    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.

Secondary outcomes

  1. New Inhaler Error Under Cognitive Load

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

    Binary outcome indicating whether inhaler technique deteriorates under cognitive load. A new inhaler error is defined as having fewer satisfactory items on the standardized 5-item inhaler technique checklist during the cognitive dual-task condition than during the single-task condition. Coded as 1 = deterioration under cognitive load and 0 = no deterioration.

  2. Worsening of Inhaler Technique Classification Under Cognitive Load

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

    Binary outcome indicating whether the participant's inhaler technique classification worsens from Acceptable during the single-task condition to Unacceptable during the cognitive dual-task condition. Inhaler technique is classified using the standardized 5-item checklist, with 4-5 satisfactory steps classified as Acceptable and 0-3 satisfactory steps classified as Unacceptable. Coded as 1 = classification worsened and 0 = no worsening.

  3. Inhaler Time Dual-Task Cost

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

    Percentage change in inhaler-use time between the cognitive dual-task and single-task conditions. It is calculated as [(dual-task inhaler time - single-task inhaler time) / single-task inhaler time] × 100. Positive values indicate slower inhaler use under cognitive load.

  4. Inhaler Cognitive Dual-Task Cost

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

    Percentage change in working-memory performance between the cognitive single-task condition and the inhaler cognitive dual-task condition. It is calculated as [(single-task cognitive accuracy - dual-task cognitive accuracy) / single-task cognitive accuracy] × 100. Positive values indicate poorer cognitive performance while using the inhaler under cognitive load.

  5. Physical Dual-Task Cost During Timed Up and Go

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

    Percentage increase in Timed Up and Go completion time during the cognitive dual-task condition compared with the single-task condition. It is calculated as [(TUG dual-task time - TUG single-task time) / TUG single-task time] × 100. Positive values indicate slower mobility performance during dual-tasking.

  6. Cognitive Dual-Task Cost During Timed Up and Go

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

    Percentage reduction in cognitive performance during the dual-task Timed Up and Go condition compared with the cognitive single-task condition. Cognitive performance is quantified using the rate of correct responses per second. The outcome is calculated as [(single-task correct-response rate - dual-task correct-response rate) / single-task correct-response rate] × 100. Positive values indicate poorer cognitive performance during dual-task walking.

  7. Change in Inhaler Completion Time Under Cognitive Load

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

    Absolute difference in inhaler-use time between the cognitive dual-task and single-task conditions. It is calculated as dual-task inhaler time minus single-task inhaler time, expressed in seconds. Positive values indicate longer inhaler-use time under cognitive load.

Study contacts

Contact information is provided by the study sponsor or research team.

Alexandru Crișan

CONTACT

[email protected]

0765525688

Sponsors and collaborators

Lead sponsor

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

Other Gov

Registry information

Official study title

Cognitive Load-Induced Inhaler Errors in COPD: Linking Dual-Task Mobility to Treatment Self-Management

Acronym: DUAL-INH

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 25, 2026
Registry last updated
Aug 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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