Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
In general, central sleep apnea is not as common as obstructive sleep apnea but it is common in patients with heart failure. It has been repeatedly shown that central sleep apnea worsens the prognosis of heart failure. The current concept in the development of CSA is hypocapnia which causes temporary cessation of respiratory neural output. Different methods for supplement of CO2 have been used to eliminate CSA. However, variation of CO2 concentration during overnight treatment and tight-fitting mask made the treatment uncomfortable. It is important to develop a device with a comfortable mask to supply constant low dose CO2 without breathing difficulty. We recently developed a device for treatment of CSA.
Objective: To determine whether the device could improve sleep quality while eliminating CSA during the overnight study. Methods: Patients with central sleep apnea diagnosed by diaphragm EMG will be recruited in this study. CO2 concentration for treatment would be manually titrated during overnight PSG. Patients were then treated with an effective lowest concentration of CO2 derived from titration under PSG on the third night. The sleep apnea hypopnea index (AHI), central sleep apnea index (CHI), arousal index (ArI), Oxygen desaturation index (ODI), sleep structure, blood pressure, heart rate, diaphragm EMG, treatment side effects and treatment preference were to be observed.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment with CO2 | Experimental | Patients were treated with an effective lowest concentration of CO2 delivered by the novel CO2 supply system. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| novel device with a comfortable mask | Device | Using a device with a comfortable mask to supply constant low dose CO2 to treat patients. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Apnea Hypopnea Index | Total number of apneas and hypopneas/total sleep time (h) | One full night |
| Central sleep apnea index | Total number of central sleep apneas/total sleep time (h) | One full night |
| Arousal Index | Total number of arousals/total sleep time(h) | One full night |
| Oxygen Desaturation Index | Total number of oxygen desaturations≥3% /total sleep time(h) | One full night |
| Sleep structure | Assessment of the sleep efficiency (percentage is calculated by dividing Total Sleep Time by Total Time in bed) | One full night |
| Sleep structure | Assessment of the sleep stage distribution (percentage calculated by diving the time of stage N1, N2, N3, NREM by total sleep time) | One full night |
| Adverse effects | Using questionnaire named side effects of feeling to assess adverse effects exiting or not, including dyspnea, noise, bloating, itchy face, dry mouth, ophthalmalgia, stuffy nose, et al. When the side effect events in intervening condition 2 times more than baseline is worse outcome. | One full night |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Yuanming Luo, PhD | The First Affiliated Hospital of Guangzhou Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Guangzhou Medical University | Guangzhou | Guangdong | 510230 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D020182 | Sleep Apnea, Central |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |