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Completed

NCT Number: NCT04907058

Central Sleep Apnea Treated by CO2 Supplied by a Novel Device

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.

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Key information

Conditions

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

Age range

18 year–82 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 510230, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

novel device with a comfortable mask

Device

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

Primary outcomes

  1. Apnea Hypopnea Index

    Time frame: One full night

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

  2. Central sleep apnea index

    Time frame: One full night

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

  3. Arousal Index

    Time frame: One full night

    Total number of arousals/total sleep time(h)

  4. Oxygen Desaturation Index

    Time frame: One full night

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

  5. Sleep structure

    Time frame: One full night

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

  6. Sleep structure

    Time frame: 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)

  7. Adverse effects

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

State Key Laboratory of Respiratory Disease

Other

Registry information

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
May 28, 2021
Registry last updated
Mar 31, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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