Central Sleep Apnea Treated by CO2 Supplied by a Novel Device

State Key Laboratory of Respiratory Disease

Status: Completed

Conditions: Central Sleep Apnea

Treatments: Device: novel device with a comfortable mask

Study type: Interventional

Funder types: Other

Identifiers

NCT04907058

202037

Details and patient eligibility

About

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.

Full 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.

Enrollment: 18 patients

Sex: All

Ages: 18 to 82 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Sequential Assignment

Masking: None (Open label)

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18 participants in 1 patient group

Treatment with CO2

Experimental group

Description:

Patients were treated with an effective lowest concentration of CO2 delivered by the novel CO2 supply system.

Treatment:

Device: novel device with a comfortable mask