Central Sleep Apnea Treated by CO2 Supplied by a Novel Device

Not Applicable

Completed

• Conditions: Central Sleep Apnea
• Interventions: Device: novel device with a comfortable mask

• Registration Number: NCT04907058
• Lead Sponsor: State Key Laboratory of Respiratory Disease

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.

Study Timeline

• Study Start: 2021-05-20
• Study First Submitted: 2021-05-20
• Study First Submitted QC: 2021-05-27
• Study First Posted: 2021-05-28
• Primary Completion: 2021-08-30
• Study Completion: 2021-09-23
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-29
• Last Update Posted: 2022-03-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Treatment with CO2	novel device with a comfortable mask	Patients were treated with an effective lowest concentration of CO2 delivered by the novel CO2 supply system.

Primary Outcome Measures

Name	Time	Method
Oxygen Desaturation Index	One full night	Total number of oxygen desaturations≥3% /total sleep time(h)
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)
Sleep structure	One full night	Assessment of the sleep stage distribution (percentage calculated by diving the time of stage N1, N2, N3, NREM by total sleep time)
Arousal Index	One full night	Total number of arousals/total sleep time(h)
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.

Trial Locations

Locations (1)

The First Affiliated Hospital of Guangzhou Medical University; 🇨🇳 Guangzhou, Guangdong, China