NCT03085641

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

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: University Medical Center Groningen · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 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.

Conditions

• Central Sleep Apnea
• Cheyne-Stokes Respiration

Interventions

Type	Name	Description
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

Timeline

• Start date: 2017-06-15
• Primary completion: 2018-10-18
• Completion: 2018-10-18
• First posted: 2017-03-21
• Last updated: 2018-12-17

Locations

1 site across 1 country: Netherlands