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

NCT ID: NCT03085641

Last Updated: 2018-12-17

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-06-15
• Study Completion Date: 2018-10-18

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 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

Keywords

High flow oxygen therapy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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%

Group Type: EXPERIMENTAL

Nasal high flow oxygen therapy

Intervention Type: DEVICE

nHFT will be titrated during a first titration night and used at home during the night for 4 weeks consecutively

Interventions

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

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Medical Center Groningen

OTHER

Sponsor Role: lead

Responsible Party

Marieke Duiverman

Pneumologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Marieke Duiverman

Role: STUDY_DIRECTOR

University Medical Center Groningen

Locations

Department of Pulmonary diseases

Groningen, , Netherlands

Countries

Netherlands

Other Identifiers

201700147

Identifier Type: -

Identifier Source: org_study_id