Treatment of Central Sleep Apnoea in Patients With Heart Failure With Nasal High Flow Therapy (nHFT)

Overview

To investigate whether nHFT is an effective treatment for patients with Chronic Heart Failure (CHF) and central sleep apnea (CSA). This study is a prospective one armed uncontrolled intervention pilot study investigating 4 weeks of nHFT at home in 10 patients with CHF and CSA.

Full Title of Study: “Treatment of Central Sleep Apnoea and Cheyne Stokes Respiration in Patients With Heart Failure: Nasal High-flow Oxygen Therapy?”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: October 18, 2018

Detailed Description

Study population: 10 CHF patients with a Left Ventricular Injection Fraction(LVEF)< 45% and CSA/Cheyne Stokes Respiration (CSR) (apnoea/hypopnea index (AHI) > 15/hour); with at least 50% of the total number of events having a central character will be included. Patients with other diseases that will influence the respiratory system negatively during sleep i.e. chronic obstructive pulmonary disease (COPD Global Initiative of Obstructive Lung Diseases (GOLD) class 3 and 4), neuromuscular diseases and thorax cage deformities, as well as patients with CHF and CSA that use another form of treatment for their CSA at the time of inclusion, will be excluded. Intervention: nHFT will be titrated during a first titration night and used at home during the night for 4 weeks consecutively. Main study parameters/endpoints: 1. To investigate the effect of nHFT with and without oxygen in reducing the apnoea/hypopnoea index during sleep after 4 weeks use nHFT. 2. To investigate improvements in oxygen desaturation index, sleep quality and sleepiness, physical condition, left ventricular ejection fraction (LVEF), heart beat variability (HRV), N-terminal natriuretic peptide (NTproBNP) after 4 weeks use nHFT . 3. Physiological condition; work of breathing and respiratory drive and measuring mouth-throat pressure.

Interventions

  • Device: Nasal high flow oxygen therapy
    • nHFT will be titrated during a first titration night and used at home during the night for 4 weeks consecutively

Arms, Groups and Cohorts

  • Experimental: Nasal high flow oxygen therapy
    • The patient is hospitalized for one night. Initially patients will start with a flow rate of 10 L/min and when they are asleep during the night 90-minute periods of the following settings will be performed: Moderate flow rate: 20 L/min without additional oxygen (with room air, which means a fractional inspired oxygen (FiO2) of 21%) High flow rate: 40-50 L/min without additional oxygen Moderate flow rate: 20 L/min with FiO2 of 28% (comparable to the 2 L/min additional oxygen through a nasal cannula) High flow rate: 40-50 L/min with FiO2 of 28%

Clinical Trial Outcome Measures

Primary Measures

  • Reduction of apnea/hypopnea index
    • Time Frame: Baseline, 4 weeks
    • the change/reduction in AHI after 4 weeks of treatment with nHFT.

Secondary Measures

  • Improvement physical condition
    • Time Frame: Baseline, 4 weeks
    • Exercise tolerance assessed with the 6-minute walking test
  • Work of breathing
    • Time Frame: Baseline titration night
    • Transdiaphragmatic pressure as a marker of diaphragmatic true work of breathing, measured with the use of oesophageal and gastric balloon catheters
  • Drive to breath
    • Time Frame: Baseline titration night, 4 weeks
    • Drive to breath assessed with surface electromyography (EMG) of the respiratory muscles
  • Sleep latency
    • Time Frame: Baseline, 4 weeks
    • Assessed as the the length of time that it takes to accomplish the transition from full wakefulness to sleep, measured by means of electro-encephalogram (ECG) as part of the polysomnography
  • Cardiac functioning
    • Time Frame: Baseline, 4 weeks
    • Left ventricular injection fraction (LVEF),
  • change in oxygen desaturation index (ODI) during sleep while on nHFT
    • Time Frame: Baseline, 4 weeks
    • measured after 4 weeks of home nHFT treatment, as compared to the baseline ODI during spontaneous nocturnal breathing.
  • Sleep efficiency
    • Time Frame: Baseline, 4 weeks
    • The percentage of total time in bed actually spent in sleep, assessed with polysomnography
  • Total rapid-eye movement (REM) stage sleep cycles recorded
    • Time Frame: Baseline, 4 weeks
    • Assessed with polysomnography
  • Heart rate variability
    • Time Frame: Baseline, 4 weeks
    • Heart rate variability will be assessed by 24-uur ECG recordings
  • N-terminal natriuretic peptide (NTproBNP)
    • Time Frame: Baseline, 4 weeks
    • Assessed in venous blood

Participating in This Clinical Trial

Inclusion Criteria

1. Moderate to severe CSA/CSR (AHI>15), in which CSA is defined when at least 50% of the apnoeas are central apnoeas 2. Heart failure with reduced ejection fraction, defined as a LVEF < 45% of predicted Exclusion Criteria:

1. Other diseases affecting respiration during sleep (COPD GOLD 3 or 4, neuromuscular disorders, thorax cage deformities) 2. At the moment of the inclusion, the patient does not have a therapy to treat the CSA, such as continuous positive airway pressure (CPAP), oxygen, bilevel intermittent positive airway pressure (BiPAP) or acetazolamide.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University Medical Center Groningen
  • Provider of Information About this Clinical Study
    • Principal Investigator: Marieke Duiverman, Pneumologist – University Medical Center Groningen
  • Overall Official(s)
    • Marieke Duiverman, Study Director, University Medical Center Groningen

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