- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT03756805
Upper Airway Stimulation Versus Continuous Positive Airway Pressure
Selective Upper Airway Stimulation Compared to Continuous Positive Airway Pressure Therapy in Patients With Obstructive Sleep Apnea: a Prospective Cohort Study
연구 개요
상세 설명
6% to 13% of the western industrialized population suffer from obstructive sleep apnea (OSA). During sleep in the pharyngeal airway a relaxation of the muscles occurs with increasing depth of sleep. Finally, this relaxation, due to the anatomical conditions, lead to obstructions of the respiratory tract, resulting in respiratory arrest (apnea) and minor respiratory changes such as hypopneas or flow limitations. The symptoms of this disease manifest themselves with varying degrees. Increased daytime sleepiness, snoring, and increased risk of cardiovascular disease can result. A significant reduction in overall quality of life can be associated with OSAS. The gold standard treatment for obstructive sleep apnea is CPAP (continuous positive airway pressure). But only about 50% to 70% of patients continue to use their device after 2 years of initial CPAP therapy. This means that 30% to 50% of patients are no longer cared for their obstructive sleep apnea. A certain proportion of younger patients, in particular, reject nocturnal ventilation therapy with CPAP from the beginning. For these patients selective upper airway stimulation (UAS) is a therapy option.
Therefore the patient receives surgically a subcutaneous stimulation device under the clavicle, which receives a signal from a respiratory sensor to selectively stimulate the hypoglossal nerve. The respiratory sensor is located in the 4th or 5th intercostal space between the patient's external and internal rib muscles. This can be used to record the patient's breathing, which allows a matched stimulation of the hypoglossal nerve. The actual stimulation lead is attached to the medial branches of the hypoglossal nerve, which are responsible for the protrusion of the tongue, in order to enable appropriate stimulation.
In this prospective cohort study, selective upper airway stimulation (UAS) will now be compared with CPAP therapy. Patients receiving CPAP therapy are compared to UAS patients who receive an upper airway stimulation. Both methods are procedures established in clinical routine, and during this investigation, the general clinical course is not deviated. Randomization does not occur because CPAP therapy is a conservative therapy and UAS therapy is a surgical therapy. Furthermore, for UAS therapy, there must be a CPAP incompliance, so that a surgical concept is justified. The CPAP group should comply with the body mass index and age of the UAS group.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Bavaria
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Munich, Bavaria, 독일, 81667
- Technical University of Munich
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- All consecutive patients who either received UAS implantation (Inspire therapy) in our Department of Otorhinolaryngology, Head and Neck Surgery at the Klinikum rechts der Isar and all patients who received a CPAP therapy since July 2013, are invited to participate in this clinical examination.
Exclusion Criteria:
- patients with the age under 18 years
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위화되지 않음
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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활성 비교기: Group 1 (CPAP)
Patient, who are receiving a CPAP
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One group of patients with CPAP
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실험적: Group 2 (UAS)
Patient, who are receiving a device for upper airway stimulation
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One group of patients with UAS
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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AHI
기간: reduction from baseline to 12 months
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Apnea Hypopnea Index measured in events per hour
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reduction from baseline to 12 months
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ODI
기간: reduction from baseline to 12 months
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Oxygen desaturation index measured in events per hour
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reduction from baseline to 12 months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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ESS
기간: improvement from baseline to 12 months
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Epworth Sleepiness Scale
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improvement from baseline to 12 months
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FOSQ
기간: improvement from baseline to 12 months
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Functional Outcome of Sleep Questionnaire
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improvement from baseline to 12 months
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Usage
기간: usage hours per night at 12 months
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Usage Hour per Night
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usage hours per night at 12 months
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공동 작업자 및 조사자
간행물 및 유용한 링크
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
- UAS vs. CPAP
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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. .
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