Central Sleep Apnea Treated by CO2 Supplied by a Novel Device

NCT04907058 | Completed DMC

• 1 other identifier: 202037
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Central Sleep Apnea

Keywords

CSA

Outcome Measures

Primary Outcomes (7)

• Apnea Hypopnea Index

  Total number of apneas and hypopneas/total sleep time (h)

  One full night

• Central sleep apnea index

  Total number of central sleep apneas/total sleep time (h)

  One full night

• Arousal Index

  Total number of arousals/total sleep time(h)

  One full night

• Oxygen Desaturation Index

  Total number of oxygen desaturations≥3% /total sleep time(h)

  One full night

• Sleep structure

  Assessment of the sleep efficiency (percentage is calculated by dividing Total Sleep Time by Total Time in bed)

  One full night

• 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

• 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

Study Arms (1)

Treatment with CO2

EXPERIMENTAL

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

Device: novel device with a comfortable mask

Interventions

novel device with a comfortable mask DEVICE

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

Treatment with CO2

Eligibility Criteria

• Age: 18 Years - 82 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Willing to participate after informed consent
• Males and females, any race and aged≥18yeras
• Objectively confirmed central sleep apnea/Cheyne Stokes Respiration with an apnoea-hypopnoea- index (AHI)≥5/h by overnight polysomnography

You may not qualify if:

• Obstructive sleep apnea
• Severe COPD，FEV1/FVC\<70% and FEV1\<60%
• Chronic CO2 retention with unknown reason
• Severe nasal congestion
• Poor understanding

Sponsors & Collaborators

• State Key Laboratory of Respiratory Disease: lead

Study Sites (1)

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 510230, China

Location

MeSH Terms

Conditions

Sleep Apnea, Central

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Yuanming Luo, PhD

  The First Affiliated Hospital of Guangzhou Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Proffessor

Study Record Dates

• First Submitted: May 20, 2021
• First Posted: May 28, 2021
• Study Start: May 20, 2021
• Primary Completion: August 30, 2021
• Study Completion: September 23, 2021
• Last Updated: March 31, 2022

Record last verified: 2022-03

Locations

CN (1)