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

Primary Purpose

Sleep Disordered Breathing, Congestive Heart Failure

Status

Terminated

Phase

Not Applicable

Locations

New Zealand

Study Type

Interventional

Intervention

Nasal High flow therapy device

About this trial

This is an interventional basic science trial for Sleep Disordered Breathing

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Fisher & Paykel Healthcare Ltd.
Middlemore Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Diagnostic PSG/PG, PSG w. nasal high flow therapy

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT02152566

First Posted

May 29, 2014

Last Updated

January 13, 2016

Sponsor

Fisher and Paykel Healthcare

1. Study Identification

Unique Protocol Identification Number

NCT02152566

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2016

Overall Recruitment Status

Terminated

Why Stopped

Difficulty with recruitment

Study Start Date

April 2014 (undefined)

Primary Completion Date

August 2014 (Actual)

Study Completion Date

August 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Fisher and Paykel Healthcare

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Sleep Disordered Breathing, Congestive Heart Failure

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

6 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Diagnostic PSG/PG, PSG w. nasal high flow therapy

Arm Type

Experimental

Arm Description

Intervention Type

Device

Intervention Name(s)

Nasal High flow therapy device

Intervention Description

Nasal high flow therapy via nasal cannula.

Primary Outcome Measure Information:

Title

Treatment Efficacy

Description

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.

Time Frame

During 1 night of Sleep on PSG

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Rachel Vicars, PhD - Eng

Organizational Affiliation

Fisher & Paykel Healthcare

Official's Role

Principal Investigator

Facility Information:

Facility Name

Fisher & Paykel Healthcare Ltd.

City

Auckland

State/Province

East Tamaki

ZIP/Postal Code

1010

Country

New Zealand

Facility Name

Middlemore Hospital

City

Auckland

State/Province

Otahuhu

ZIP/Postal Code

2025

Country

New Zealand

12. IPD Sharing Statement

Learn more about this trial

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

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