Central Sleep Apnea Clinical Trial
— RELAXOfficial title:
Treatment of Central Sleep Apnoea and Cheyne Stokes Respiration in Patients With Heart Failure: Nasal High-flow Oxygen Therapy?
Verified date | December 2018 |
Source | University Medical Center Groningen |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
Country | Name | City | State |
---|---|---|---|
Netherlands | Department of Pulmonary diseases | Groningen |
Lead Sponsor | Collaborator |
---|---|
University Medical Center Groningen |
Netherlands,
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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