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

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ClinicalTrials.gov Identifier: NCT02152566
Recruitment Status : Terminated (Difficulty with recruitment)
First Posted : June 2, 2014
Results First Posted : September 17, 2015
Last Update Posted : February 8, 2016
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Sleep Disordered Breathing Congestive Heart Failure Device: Nasal High flow therapy device Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Study of the Effects of Nasal High Flow Therapy as a Treatment Option for Patients With Respiratory Insufficiencies During Sleep.
Study Start Date : April 2014
Actual Primary Completion Date : August 2014
Actual Study Completion Date : August 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
Device: Nasal High flow therapy device
Nasal high flow therapy via nasal cannula.




Primary Outcome Measures :
  1. Treatment Efficacy [ Time Frame: 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02152566


Locations
New Zealand
Fisher & Paykel Healthcare Ltd.
Auckland, East Tamaki, New Zealand, 1010
Middlemore Hospital
Auckland, Otahuhu, New Zealand, 2025
Sponsors and Collaborators
Fisher and Paykel Healthcare
Investigators
Principal Investigator: Rachel Vicars, PhD - Eng Fisher & Paykel Healthcare

Responsible Party: Fisher and Paykel Healthcare
ClinicalTrials.gov Identifier: NCT02152566     History of Changes
Other Study ID Numbers: CIA-117
First Posted: June 2, 2014    Key Record Dates
Results First Posted: September 17, 2015
Last Update Posted: February 8, 2016
Last Verified: January 2016

Additional relevant MeSH terms:
Heart Failure
Respiratory Insufficiency
Pulmonary Valve Insufficiency
Heart Diseases
Cardiovascular Diseases
Respiration Disorders
Respiratory Tract Diseases
Heart Valve Diseases