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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03085641
Other study ID # 201700147
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


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
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