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

NCT ID: NCT02152566

Last Updated: 2016-02-08

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-04-30
• Study Completion Date: 2014-08-31

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.

Conditions

Sleep Disordered Breathing; Congestive Heart Failure

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Nasal High flow therapy device

Intervention Type: DEVICE

Nasal high flow therapy via nasal cannula.

Interventions

Nasal High flow therapy device

Nasal high flow therapy via nasal cannula.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fisher and Paykel Healthcare

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rachel Vicars, PhD - Eng

Role: PRINCIPAL_INVESTIGATOR

Fisher & Paykel Healthcare

Locations

Fisher & Paykel Healthcare Ltd.

Auckland, East Tamaki, New Zealand

Middlemore Hospital

Auckland, Otahuhu, New Zealand

Countries

New Zealand

Other Identifiers

CIA-117

Identifier Type: -

Identifier Source: org_study_id