Nasal High Flow Therapy for the Treatment of Respiratory Insufficiencies During Sleep
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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
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|
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.
- 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.
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
|Fisher & Paykel Healthcare Ltd.|
|Auckland, East Tamaki, New Zealand, 1010|
|Auckland, Otahuhu, New Zealand, 2025|
|Principal Investigator:||Rachel Vicars, PhD - Eng||Fisher & Paykel Healthcare|