Central Sleep Apnea Treated by CO2 Supplied by a Novel Device

NCT ID: NCT04907058

Last Updated: 2022-03-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-20
• Study Completion Date: 2021-09-23

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.

Conditions

Central Sleep Apnea

Study Design

• Allocation Method: NA
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment with CO2

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

Group Type: EXPERIMENTAL

novel device with a comfortable mask

Intervention Type: DEVICE

Using a device with a comfortable mask to supply constant low dose CO2 to treat patients.

Interventions

novel device with a comfortable mask

Using a device with a comfortable mask to supply constant low dose CO2 to treat patients.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 82 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

State Key Laboratory of Respiratory Disease

OTHER

Sponsor Role: lead

Responsible Party

Yuan-Ming Luo

Proffessor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yuanming Luo, PhD

Role: PRINCIPAL_INVESTIGATOR

The First Affiliated Hospital of Guangzhou Medical University

Locations

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

Countries

China

Other Identifiers

202037

Identifier Type: -

Identifier Source: org_study_id