COPDDUAL-INHNCT07786220
Cognitive Load and Inhaler Technique in COPD
A study testing Working-Memory Cognitive Load During Inhaler Use and Single-Task Inhaler Use in people with COPD, run by Spitalul Clinic de Boli Infecțioase și Pneumoftiziologie Dr. Victor Babeș Timișoara at 1 site in Romania.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- COPD
- What is being tested?
- Working-Memory Cognitive Load During Inhaler Use and Single-Task Inhaler Use
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteRomania
- Study dates
- 21 Aug 2026to 30 Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Romania1 site, 1 recruiting
- Recruiting
"Dr. Victor Babeș" Clinical Hospital of Infectious Diseases and Pneumophthisiology, Timișoara
Timișoara, Timiș County, 300041
Alexandru Crișan, 0765525688, crisan@umft.ro
About this study
Official title: Cognitive Load-Induced Inhaler Errors in COPD: Linking Dual-Task Mobility to Treatment Self-Management
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
- Being tested
- Working-Memory Cognitive Load During Inhaler Use, Single-Task Inhaler Use
- Keywords
- Chronic Obstructive Pulmonary Disease, Inhaler Technique, Cognitive Load, Dual-Task Performance, Timed Up and Go
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Working-Memory Cognitive Load During Inhaler UseBehavioural
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 UseBehavioural
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Working-Memory Cognitive Load During Inhaler Use; Behavioral: Single-Task Inhaler Use |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During the single study visit, immediately after completion of both inhaler conditions
Secondary outcomes (7)
New Inhaler Error Under Cognitive Load
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.
Measured: During the single study visit, immediately after completion of both inhaler conditions
Worsening of Inhaler Technique Classification Under Cognitive Load
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.
Measured: During the single study visit, immediately after completion of both inhaler conditions
Inhaler Time Dual-Task Cost
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.
Measured: During the single study visit, immediately after completion of both inhaler conditions
Inhaler Cognitive Dual-Task Cost
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.
Measured: During the single study visit, immediately after completion of the inhaler cognitive assessments
Physical Dual-Task Cost During Timed Up and Go
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.
Measured: During the single study visit, immediately after completion of the single-task and dual-task Timed Up and Go assessments
Cognitive Dual-Task Cost During Timed Up and Go
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.
Measured: During the single study visit, immediately after completion of the cognitive single-task and dual-task Timed Up and Go assessments
Change in Inhaler Completion Time Under Cognitive Load
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.
Measured: During the single study visit, immediately after completion of both inhaler conditions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2026
- Study start21 Aug 2026
- Primary completion30 Sep 2027 (estimated)
- Study completion30 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Spitalul Clinic de Boli Infecțioase și Pneumoftiziologie Dr. Victor Babeș Timișoara
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Crisan Alexandru Florian, Spitalul Clinic de Boli Infecțioase și Pneumoftiziologie Dr. Victor Babeș Timișoara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07786220
- Sponsor's protocol ID
- COPD-DT-INHALER-2026-01
- Acronym
- DUAL-INH
- Status last verified
- Aug 2026
- First submitted
- 21 Aug 2026
- Last updated
- 26 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be made publicly available. De-identified data may be provided by the corresponding investigator upon reasonable request, subject to approval by the study team and, where required, the relevant ethics committee and institutional data-protection requirements.
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Load-Induced Inhaler Errors in COPD: Linking Dual-Task Mobility to Treatment Self-Management
- ClinicalTrials.gov ID
- NCT07786220
- Acronym / sponsor ID
- DUAL-INH / COPD-DT-INHALER-2026-01
- Conditions
- COPD
- Keywords
- Chronic Obstructive Pulmonary Disease, Inhaler Technique, Cognitive Load, Dual-Task Performance, Timed Up and Go
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Spitalul Clinic de Boli Infecțioase și Pneumoftiziologie Dr. Victor Babeș TimișoaraOther government
- Study start
- 21 Aug 2026 (actual)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 30 Nov 2027 (estimated)
- First posted
- 25 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Single-Task Followed by Cognitive Dual-Task | Experimental | Behavioral: Working-Memory Cognitive Load During Inhaler Use, Behavioral: Single-Task Inhaler UseParticipants 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. |
| Cognitive Dual-Task Followed by Single-Task | Experimental | Behavioral: Working-Memory Cognitive Load During Inhaler Use, Behavioral: Single-Task Inhaler UseParticipants 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. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Working-Memory Cognitive Load During Inhaler UseParticipants 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. | Behavioural | Cognitive Dual-Task Followed by Single-Task, Single-Task Followed by Cognitive Dual-Task |
| Single-Task Inhaler UseParticipants 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. | Behavioural | Cognitive Dual-Task Followed by Single-Task, Single-Task Followed by Cognitive Dual-Task |
Primary outcome
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.
7 secondary outcomes
New Inhaler Error Under Cognitive Load
Time frame: During the single study visit, immediately after completion of both inhaler conditions
Worsening of Inhaler Technique Classification Under Cognitive Load
Time frame: During the single study visit, immediately after completion of both inhaler conditions
Inhaler Time Dual-Task Cost
Time frame: During the single study visit, immediately after completion of both inhaler conditions
Inhaler Cognitive Dual-Task Cost
Time frame: During the single study visit, immediately after completion of the inhaler cognitive assessments
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
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
Change in Inhaler Completion Time Under Cognitive Load
Time frame: During the single study visit, immediately after completion of both inhaler conditions
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be made publicly available. De-identified data may be provided by the corresponding investigator upon reasonable request, subject to approval by the study team and, where required, the relevant ethics committee and institutional data-protection requirements.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Working-Memory Cognitive Load During Inhaler Use and Single-Task Inhaler Use in people with COPD, run by Spitalul Clinic de Boli Infecțioase și Pneumoftiziologie Dr. Victor Babeș Timișoara at 1 site in Romania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Romania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alexandru Crișan (0765525688, crisan@umft.ro), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2026.