Nasal High Flow Therapy for the Treatment of Respiratory Insufficiencies During Sleep
Study of the Effects of Nasal High Flow Therapy as a Treatment Option for Patients With Respiratory Insufficiencies During Sleep.
Respiratory insufficiencies during sleep can lead to reductions in the level of oxygen in the blood during the night, which has been shown to contribute to a range of morbidities.
The purpose of this study is to assess the possibility that a nasal high flow therapy device may be able to treat respiratory insufficiencies, by stabilizing breathing and preventing reduction in blood oxygen.
Heart failure patients will be screened at a heart failure clinic, and will be asked to undergo an overnight sleep study to determine is they exhibit respiratory insufficiencies during sleep. This sleep study may be completed in the sleep laboratory (attended polysomnography, PSG) or in-home (in-home polygraphy, PG). If they are diagnosed with respiratory insufficiencies, they will be asked to attend further overnight studies to see if treatment with nasal high flow therapy can be used to stabilize breathing.
연구 개요
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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East Tamaki
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Auckland, East Tamaki, 뉴질랜드, 1010
- Fisher & Paykel Healthcare Ltd.
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Otahuhu
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Auckland, Otahuhu, 뉴질랜드, 2025
- Middlemore Hospital
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Men and Women aged ≥ 18 years
- Heart Failure from ischemic or non-ischemic dilated cardiomyopathy for ≥ 6 months
- Left ventricular systolic dysfunction (LVEF ≤45% by echocardiography performed within 3 months of the screening visit, or if not within 3 months, a justification provided by the cardiologist for why a repeat echocardiography is not required, for example, because the subject's condition has remained stable since their echocardiography). All echocardiography must be within a maximum of 1 year of the screening visit.
- New York Heart Association Class II or III after optimization of medical therapy
- Stable Clinical Status on stable optimal medical therapy for ≥ 1 month before entry
Exclusion Criteria:
- Unstable angina
- Myocardial infarction within the last 12 months
- Cardiac surgery within the previous 6 months
- Pregnancy
- Unwilling or unable to provide informed consent
- Uncontrolled arrhythmias
- Severe valvular heart disease
- Current/prior use of mechanical ventilation (including CPAP). At the investigator's discretion.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 기초 과학
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Diagnostic PSG/PG, PSG w. nasal high flow therapy
All patients recruited will undergo a diagnostic sleep study, either a full in laboratory attended polysomnography (PSG), or an in-home polygraphy (PG).
If respiratory insufficiencies with Cheyne-Stokes respiration (CSR) are detected, these patients will undergo an overnight in laboratory attended PSG on a nasal high flow therapy device to test the primary endpoint of this study.
Patients without respiratory insufficiencies after the first PSG/PG will take no further part in the trial.
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Nasal high flow therapy via nasal cannula.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Treatment Efficacy
기간: During 1 night of Sleep on PSG
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The primary endpoint of the trial is to the efficacy of using nasal high flow therapy to stabilize breathing, as measured by the breath flow signal from PSG.
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During 1 night of Sleep on PSG
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공동 작업자 및 조사자
수사관
- 수석 연구원: Rachel Vicars, PhD - Eng, Fisher & Paykel Healthcare
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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