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.
Aperçu de l'étude
Statut
Intervention / Traitement
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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East Tamaki
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Auckland, East Tamaki, Nouvelle-Zélande, 1010
- Fisher & Paykel Healthcare Ltd.
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Otahuhu
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Auckland, Otahuhu, Nouvelle-Zélande, 2025
- Middlemore Hospital
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Science basique
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: 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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Treatment Efficacy
Délai: 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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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Rachel Vicars, PhD - Eng, Fisher & Paykel Healthcare
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- CIA-117
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