Not provided
Not provided
Not provided
Not provided
Side effects
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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:
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nasal high flow oxygen therapy | Experimental | 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:
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nasal high flow oxygen therapy | Device | nHFT will be titrated during a first titration night and used at home during the night for 4 weeks consecutively |
|
| Measure | Description | Time Frame |
|---|---|---|
| Reduction of apnea/hypopnea index | the change/reduction in AHI after 4 weeks of treatment with nHFT. | Baseline, 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement physical condition | Exercise tolerance assessed with the 6-minute walking test | Baseline, 4 weeks |
| Work of breathing | Transdiaphragmatic pressure as a marker of diaphragmatic true work of breathing, measured with the use of oesophageal and gastric balloon catheters |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Marieke Duiverman | University Medical Center Groningen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Pulmonary diseases | Groningen | Netherlands |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D020182 | Sleep Apnea, Central |
| D002639 | Cheyne-Stokes Respiration |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
prospective one armed uncontrolled intervention pilot study
Not provided
Not provided
Not provided
Not provided
| Baseline titration night |
| Drive to breath | Drive to breath assessed with surface electromyography (EMG) of the respiratory muscles | Baseline titration night, 4 weeks |
| 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 |
| Cardiac functioning | Left ventricular injection fraction (LVEF), | Baseline, 4 weeks |
| 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 |
| Sleep efficiency | The percentage of total time in bed actually spent in sleep, assessed with polysomnography | Baseline, 4 weeks |
| Total rapid-eye movement (REM) stage sleep cycles recorded | Assessed with polysomnography | Baseline, 4 weeks |
| Heart rate variability | Heart rate variability will be assessed by 24-uur ECG recordings | Baseline, 4 weeks |
| N-terminal natriuretic peptide (NTproBNP) | Assessed in venous blood | Baseline, 4 weeks |
| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |