Cognitive Load and Inhaler Technique in COPD (DUAL-INH)
25 août 2026 mis à jour par: Crisan Alexandru Florian, Spitalul Clinic de Boli Infecțioase și Pneumoftiziologie Dr. Victor Babeș Timișoara
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.
Aperçu de l'étude
Statut
Recrutement
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Estimé)
100
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Alexandru Crișan
- Numéro de téléphone: 0765525688
- E-mail: crisan@umft.ro
Lieux d'étude
-
-
Timiș County
-
Timișoara, Timiș County, Roumanie, 300041
- Recrutement
- "Dr. Victor Babeș" Clinical Hospital of Infectious Diseases and Pneumophthisiology, Timișoara
-
Contact:
- Alexandru Crișan
- Numéro de téléphone: 0765525688
- E-mail: crisan@umft.ro
-
-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Non
La description
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
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Autre
- Répartition: Randomisé
- Modèle interventionnel: Affectation croisée
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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.
|
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.
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.
|
|
Expérimental: 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.
|
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.
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.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in Inhaler Technique Performance Under Cognitive Load
Délai: 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.
|
During the single study visit, immediately after completion of both inhaler conditions
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
New Inhaler Error Under Cognitive Load
Délai: 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.
|
During the single study visit, immediately after completion of both inhaler conditions
|
|
Worsening of Inhaler Technique Classification Under Cognitive Load
Délai: 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.
|
During the single study visit, immediately after completion of both inhaler conditions
|
|
Inhaler Time Dual-Task Cost
Délai: 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.
|
During the single study visit, immediately after completion of both inhaler conditions
|
|
Inhaler Cognitive Dual-Task Cost
Délai: 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.
|
During the single study visit, immediately after completion of the inhaler cognitive assessments
|
|
Physical Dual-Task Cost During Timed Up and Go
Délai: 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.
|
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
Délai: 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.
|
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
Délai: 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.
|
During the single study visit, immediately after completion of both inhaler conditions
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
21 août 2026
Achèvement primaire (Estimé)
30 septembre 2027
Achèvement de l'étude (Estimé)
30 novembre 2027
Dates d'inscription aux études
Première soumission
21 août 2026
Première soumission répondant aux critères de contrôle qualité
21 août 2026
Première publication (Réel)
25 août 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
26 août 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
25 août 2026
Dernière vérification
1 août 2026
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- COPD-DT-INHALER-2026-01
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
Description du régime IPD
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.
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .