Cognitive Load and Inhaler Technique in COPD (DUAL-INH)
2026년 8월 25일 업데이트: 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.
연구 개요
상태
모병
정황
연구 유형
중재적
등록 (추정된)
100
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Alexandru Crișan
- 전화번호: 0765525688
- 이메일: crisan@umft.ro
연구 장소
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Timiș County
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Timișoara, Timiș County, 루마니아, 300041
- 모병
- "Dr. Victor Babeș" Clinical Hospital of Infectious Diseases and Pneumophthisiology, Timișoara
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연락하다:
- Alexandru Crișan
- 전화번호: 0765525688
- 이메일: crisan@umft.ro
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 다른
- 할당: 무작위
- 중재 모델: 크로스오버 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 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.
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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.
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실험적: 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.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in Inhaler Technique Performance Under Cognitive Load
기간: During the single study visit, immediately after completion of both inhaler conditions
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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.
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During the single study visit, immediately after completion of both inhaler conditions
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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New Inhaler Error Under Cognitive Load
기간: During the single study visit, immediately after completion of both inhaler conditions
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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.
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During the single study visit, immediately after completion of both inhaler conditions
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Worsening of Inhaler Technique Classification Under Cognitive Load
기간: During the single study visit, immediately after completion of both inhaler conditions
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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.
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During the single study visit, immediately after completion of both inhaler conditions
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Inhaler Time Dual-Task Cost
기간: During the single study visit, immediately after completion of both inhaler conditions
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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.
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During the single study visit, immediately after completion of both inhaler conditions
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Inhaler Cognitive Dual-Task Cost
기간: During the single study visit, immediately after completion of the inhaler cognitive assessments
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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.
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During the single study visit, immediately after completion of the inhaler cognitive assessments
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Physical Dual-Task Cost During Timed Up and Go
기간: During the single study visit, immediately after completion of the single-task and dual-task Timed Up and Go assessments
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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.
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During the single study visit, immediately after completion of the single-task and dual-task Timed Up and Go assessments
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Cognitive Dual-Task Cost During Timed Up and Go
기간: During the single study visit, immediately after completion of the cognitive single-task and dual-task Timed Up and Go assessments
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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.
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During the single study visit, immediately after completion of the cognitive single-task and dual-task Timed Up and Go assessments
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Change in Inhaler Completion Time Under Cognitive Load
기간: During the single study visit, immediately after completion of both inhaler conditions
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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.
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During the single study visit, immediately after completion of both inhaler conditions
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2026년 8월 21일
기본 완료 (추정된)
2027년 9월 30일
연구 완료 (추정된)
2027년 11월 30일
연구 등록 날짜
최초 제출
2026년 8월 21일
QC 기준을 충족하는 최초 제출
2026년 8월 21일
처음 게시됨 (실제)
2026년 8월 25일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 8월 26일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 8월 25일
마지막으로 확인됨
2026년 8월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- COPD-DT-INHALER-2026-01
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
아니요
IPD 계획 설명
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.
약물 및 장치 정보, 연구 문서
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아니
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .