Clinical trial NCT03085641: Treatment of Central Sleep Apnoea in Patients With Heart Failure With Nasal High Flow Therapy (nHFT)
Official title: Treatment of Central Sleep Apnoea and Cheyne Stokes Respiration in Patients With Heart Failure: Nasal High-flow Oxygen Therapy?
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Central Sleep Apnea
Cheyne-Stokes Respiration
Keywords: High flow oxygen therapy
Lead sponsor: University Medical Center Groningen
Sponsor class: OTHER
First posted: 2017-03-21
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: prospective one armed uncontrolled intervention pilot study
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Reduction of apnea/hypopnea index
timeFrame: Baseline, 4 weeks
Secondary outcomes:
measure: Improvement physical condition
timeFrame: Baseline, 4 weeks
measure: Work of breathing
timeFrame: Baseline titration night
measure: Drive to breath
timeFrame: Baseline titration night, 4 weeks
measure: Sleep latency
timeFrame: Baseline, 4 weeks
measure: Cardiac functioning
timeFrame: Baseline, 4 weeks
measure: change in oxygen desaturation index (ODI) during sleep while on nHFT
timeFrame: Baseline, 4 weeks
measure: Sleep efficiency
timeFrame: Baseline, 4 weeks
measure: Total rapid-eye movement (REM) stage sleep cycles recorded
timeFrame: Baseline, 4 weeks
measure: Heart rate variability
timeFrame: Baseline, 4 weeks
measure: N-terminal natriuretic peptide (NTproBNP)
timeFrame: Baseline, 4 weeks
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: Department of Pulmonary diseases
Study officials:
affiliation: University Medical Center Groningen
name: Marieke Duiverman
role: STUDY_DIRECTOR
References: