- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07563283
Singing Intervention for Chronic Obstructive Pulmonary Disease (COPD) (EMPOWER)
Why is this study being done? Chronic Obstructive Pulmonary Disease (COPD) causes airflow blockage creating breathing issues, distress, and lower well-being. COPD also causes hyperinflation of the lungs. The investigators are doing the study to learn more about improving lung function for patients with COPD by using voice-based experiences.
What is being tested in this study? If singing/vocalizing can improve lung function.
How long will I be in the study? The study will last 4 weeks and involve 2 in-person visits to KUMC with virtual vocal sessions two times a week over Zoom.
연구 개요
상세 설명
Study Significance: This study is intended to show if air trapping in functional small airways disease (fSAD) in COPD patients is reduced by a targeted music-based singing intervention.
Air trapping in fSAD in COPD is associated with the experience of breathlessness or dyspnea, which is a primary source of patient distress. Air trapping may be mitigated by activities that support slow, controlled, and more complete exhalation. Because singing requires sustained delivery of consistent air pressure for sound production, training in this activity aims to strengthen respiratory musculature to improve airflow control and increase efficient use of each breath. The investigators believe that singing training will be beneficial in strengthening the respiratory musculature and emptying the lungs, possibly reducing the amount of trapped air.
A major gap exists in understanding whether singing is effective for improving lung function in COPD. Previous interventions based in group singing have been focused on improving social and emotional outcomes, but they do not specifically address the potential physiological benefits of singing as described above. The investigators aim to show specific targeted manipulation of music elements within tailored vocalization activities can successfully improve lung function and reduce dyspnea in patients with COPD, while preserving social and emotional benefits of other more generalized singing interventions. The investigators are focusing on air trapping due to small airways disease as a key symptom that leads to patient experience of dyspnea.(13, 14) Other aspects of COPD pathology and symptoms may be improved by the singing intervention, including a sense of hope through a sense of agency in their own psychological health.
The goal of the pilot study is to determine the feasibility of providing a music-based intervention targeting the issue of air trapping, improve functional small airways disease, and improve other symptoms of COPD and further define the details of the intervention.
This study will determine participant acceptability of a newly developed music-based intervention hoped to be beneficial for people with COPD. If successful, our proposed singing intervention will improve lung function health through reduced air trapping due to hyperinflation, improve patient experience of dyspnea and foster positive psychological health.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Kansas
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Kansas City, Kansas, 미국, 66160
- University Of Kansas Medical Center
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Participants 18 years of age or older
- Diagnosis of COPD
- Airflow obstruction and resting hyperinflation of the lung
- Able to hear within normal range with correction if needed
Exclusion Criteria:
- Pregnancy will be excluded for CT imaging safety and radiation safety
- Alpha-1 antitrypsin
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 다른
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 4-week singing intervention
Individual virtual singing sessions with a board-certified music therapist designed to target complete exhalation and reduce air trapping
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Using the Therapeutic Function of Music Plan, this individually tailored music therapy used singing and vocal exercises, guided by a board-certified music therapist, to aid in complete exhalation and reduce air trapping that occurs in chronic obstructive pulmonary disease (COPD).
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Quantitative Computed Tomography (qCT) Air Trapping
기간: Change from baseline after four weeks of the EMPOWER intervention
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Functional Small Airways Disease Percent (range 0-100), indicating non-emphysematous air trapping percentage (fSAD) as lung volume percent of low attenuation areas below a radiodensity of -856 Hounsfield units (HU) on expiratory computed tomography (CT) and above -950HU on inspiratory CT.
Higher values indicate greater air trapping and worse lung function.
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Change from baseline after four weeks of the EMPOWER intervention
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Forced Expiratory Volume in 1 second (FEV1)
기간: Change from baseline after four weeks of the EMPOWER intervention
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FEV1 measures the maximum volume of air (in Liters) forcefully exhaled in the first second of a coached spirometric assessment or pulmonary function test (PFT).
Lower FEV1 indicates worse lung function and obstructive defect in the lungs.
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Change from baseline after four weeks of the EMPOWER intervention
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Chronic Obstructive Pulmonary Disease (COPD) Assessment Test (CAT)
기간: Change from baseline after four weeks of the EMPOWER intervention
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Patient reported symptoms of COPD.
The CAT scale contains eight patient-completed questions to assess and monitor COPD symptoms, including the impact on daily life, cough, phlegm, breathlessness, sleep, confidence, and energy.
Scores range from 0-5 on each question for a total scale range of 0-40, with higher scores indicating worse respiratory symptoms.
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Change from baseline after four weeks of the EMPOWER intervention
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공동 작업자 및 조사자
수사관
- 수석 연구원: Rebecca J Lepping, PhD, University Of Kansas Medical Center
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- STUDY00160422
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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singing intervention for COPD에 대한 임상 시험
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University of North Carolina, Chapel HillEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)아직 모집하지 않음