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

Central Sleep Apnea Clinical Trial

— RELAX  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03085641
• Other study ID #: 201700147
• Status: Terminated
• Phase: N/A
• Start date: June 15, 2017
• Est. completion date: October 18, 2018

Study information

• Verified date: December 2018
• Source: University Medical Center Groningen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: October 18, 2018
• Est. primary completion date: October 18, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Apnea
• Central Sleep Apnea
• Cheyne-Stokes Respiration
• Heart Failure
• Sleep Apnea Syndromes
• Sleep Apnea, Central

Intervention

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

Locations

Country	Name	City	State
Netherlands	Department of Pulmonary diseases	Groningen

Sponsors (1)

Lead Sponsor	Collaborator
University Medical Center Groningen

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction of apnea/hypopnea index	the change/reduction in AHI after 4 weeks of treatment with nHFT.	Baseline, 4 weeks
Secondary	Improvement physical condition	Exercise tolerance assessed with the 6-minute walking test	Baseline, 4 weeks
Secondary	Work of breathing	Transdiaphragmatic pressure as a marker of diaphragmatic true work of breathing, measured with the use of oesophageal and gastric balloon catheters	Baseline titration night
Secondary	Drive to breath	Drive to breath assessed with surface electromyography (EMG) of the respiratory muscles	Baseline titration night, 4 weeks
Secondary	Sleep latency	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	Baseline, 4 weeks
Secondary	Cardiac functioning	Left ventricular injection fraction (LVEF),	Baseline, 4 weeks
Secondary	change in oxygen desaturation index (ODI) during sleep while on nHFT	measured after 4 weeks of home nHFT treatment, as compared to the baseline ODI during spontaneous nocturnal breathing.	Baseline, 4 weeks
Secondary	Sleep efficiency	The percentage of total time in bed actually spent in sleep, assessed with polysomnography	Baseline, 4 weeks
Secondary	Total rapid-eye movement (REM) stage sleep cycles recorded	Assessed with polysomnography	Baseline, 4 weeks
Secondary	Heart rate variability	Heart rate variability will be assessed by 24-uur ECG recordings	Baseline, 4 weeks
Secondary	N-terminal natriuretic peptide (NTproBNP)	Assessed in venous blood	Baseline, 4 weeks