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

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

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

Brief Summary:

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.


Detailed Summary:

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.

Sponsor: University Medical Center Groningen

Current Primary Outcome: Reduction of apnea/hypopnea index [ Time Frame: Baseline, 4 weeks ]

the change/reduction in AHI after 4 weeks of treatment with nHFT.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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


Original Secondary Outcome:

  • 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-ecephalogram (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


Information By: University Medical Center Groningen

Dates:
Date Received: March 8, 2017
Date Started: June 15, 2017
Date Completion: April 1, 2018
Last Updated: March 21, 2017
Last Verified: March 2017