Nasal High Flow Therapy for the Treatment of Respiratory Insufficiencies During Sleep

Not Applicable

Terminated

• Conditions: Congestive Heart Failure; Sleep Disordered Breathing
• Interventions: Device: Nasal High flow therapy device

• Registration Number: NCT02152566
• Lead Sponsor: Fisher and Paykel Healthcare

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-04
• Study First Submitted: 2014-05-29
• Study First Submitted QC: 2014-05-29
• Study First Posted: 2014-06-02
• Primary Completion: 2014-08
• Study Completion: 2014-08
• Results First Submitted: 2015-08-19
• Results First Submitted QC: 2015-08-19
• Results First Posted: 2015-09-17
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-13
• Last Update Posted: 2016-02-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 6

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Diagnostic PSG/PG, PSG w. nasal high flow therapy	Nasal High flow therapy device	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.

Primary Outcome Measures

Name	Time	Method
Treatment Efficacy	During 1 night of Sleep on PSG	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.

Trial Locations

Locations (2)

Fisher & Paykel Healthcare Ltd.; 🇳🇿 Auckland, East Tamaki, New Zealand

Middlemore Hospital; 🇳🇿 Auckland, Otahuhu, New Zealand