Central Sleep Apnea
Conditions
Keywords
CSA
Brief summary
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.
Detailed description
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.
Interventions
DEVICEnovel device with a comfortable mask
Using a device with a comfortable mask to supply constant low dose CO2 to treat patients.
Sponsors
State Key Laboratory of Respiratory Disease
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 82 Years
Healthy volunteers
No
Inclusion criteria
1. Willing to participate after informed consent 2. Males and females, any race and aged≥18yeras 3. Objectively confirmed central sleep apnea/Cheyne Stokes Respiration with an apnoea-hypopnoea- index (AHI)≥5/h by overnight polysomnography
Exclusion criteria
1. Obstructive sleep apnea 2. Severe COPD，FEV1/FVC\<70% and FEV1\<60% 3. Chronic CO2 retention with unknown reason 4. Severe nasal congestion 5. Poor understanding
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Apnea Hypopnea Index | One full night | Total number of apneas and hypopneas/total sleep time (h) |
| Central sleep apnea index | One full night | Total number of central sleep apneas/total sleep time (h) |
| Arousal Index | One full night | Total number of arousals/total sleep time(h) |
| Oxygen Desaturation Index | One full night | Total number of oxygen desaturations≥3% /total sleep time(h) |
| Sleep structure | One full night | Assessment of the sleep efficiency (percentage is calculated by dividing Total Sleep Time by Total Time in bed) |
| Adverse effects | One full night | 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. |
Countries
China
Outcome results
None listed