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

Congestive Heart Failure Clinical Trial

Official title:

Study of the Effects of Nasal High Flow Therapy as a Treatment Option for Patients With Respiratory Insufficiencies During Sleep.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02152566
• Other study ID #: CIA-117
• Status: Terminated
• Phase: N/A
• First received: May 29, 2014
• Last updated: January 13, 2016
• Start date: April 2014
• Est. completion date: August 2014

Study information

• Verified date: January 2016
• Source: Fisher and Paykel Healthcare
• Contact: n/a
• Is FDA regulated: No
• Health authority: New Zealand: Health and Disability Ethics Committees
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Congestive Heart Failure
• Heart Failure
• Pulmonary Valve Insufficiency
• Respiratory Insufficiency
• Sleep Disordered Breathing

Intervention

Device:
• Nasal High flow therapy device
Nasal high flow therapy via nasal cannula.

Locations

Country	Name	City	State
New Zealand	Fisher & Paykel Healthcare Ltd.	Auckland	East Tamaki
New Zealand	Middlemore Hospital	Auckland	Otahuhu

Sponsors (1)

Lead Sponsor	Collaborator
Fisher and Paykel Healthcare

Country where clinical trial is conducted

New Zealand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment Efficacy	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.	During 1 night of Sleep on PSG	No