Central Sleep Apnea Treated by CO2 Supplied by a Novel Device

Central Sleep Apnea Clinical Trial

Official title:

Central Sleep Apnea Treated by CO2 Supplied by a Novel Device

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04907058
• Other study ID #: 202037
• Status: Completed
• Phase: N/A
• Start date: May 20, 2021
• Est. completion date: September 23, 2021

Study information

• Verified date: March 2022
• Source: State Key Laboratory of Respiratory Disease
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: September 23, 2021
• Est. primary completion date: August 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 82 Years

Eligibility

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

Related Conditions & MeSH terms

• Apnea
• Central Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Central

Intervention

Device:
• novel device with a comfortable mask
Using a device with a comfortable mask to supply constant low dose CO2 to treat patients.

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Guangzhou Medical University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
State Key Laboratory of Respiratory Disease

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Apnea Hypopnea Index	Total number of apneas and hypopneas/total sleep time (h)	One full night
Primary	Central sleep apnea index	Total number of central sleep apneas/total sleep time (h)	One full night
Primary	Arousal Index	Total number of arousals/total sleep time(h)	One full night
Primary	Oxygen Desaturation Index	Total number of oxygen desaturations=3% /total sleep time(h)	One full night
Primary	Sleep structure	Assessment of the sleep efficiency (percentage is calculated by dividing Total Sleep Time by Total Time in bed)	One full night
Primary	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
Primary	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