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Central Sleep Apnea Treated by CO2 Supplied by a Novel Device

Primary Purpose

Central Sleep Apnea

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
novel device with a comfortable mask
Sponsored by
State Key Laboratory of Respiratory Disease
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Central Sleep Apnea focused on measuring CSA

Eligibility Criteria

18 Years - 82 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The First Affiliated Hospital of Guangzhou Medical University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment with CO2

Arm Description

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

Outcomes

Primary Outcome Measures

Apnea Hypopnea Index
Total number of apneas and hypopneas/total sleep time (h)
Central sleep apnea index
Total number of central sleep apneas/total sleep time (h)
Arousal Index
Total number of arousals/total sleep time(h)
Oxygen Desaturation Index
Total number of oxygen desaturations≥3% /total sleep time(h)
Sleep structure
Assessment of the sleep efficiency (percentage is calculated by dividing Total Sleep Time by Total Time in bed)
Sleep structure
Assessment of the sleep stage distribution (percentage calculated by diving the time of stage N1, N2, N3, NREM by total sleep time)
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.

Secondary Outcome Measures

Full Information

First Posted
May 20, 2021
Last Updated
March 29, 2022
Sponsor
State Key Laboratory of Respiratory Disease
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1. Study Identification

Unique Protocol Identification Number
NCT04907058
Brief Title
Central Sleep Apnea Treated by CO2 Supplied by a Novel Device
Official Title
Central Sleep Apnea Treated by CO2 Supplied by a Novel Device
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
May 20, 2021 (Actual)
Primary Completion Date
August 30, 2021 (Actual)
Study Completion Date
September 23, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
State Key Laboratory of Respiratory Disease

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Central Sleep Apnea
Keywords
CSA

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment with CO2
Arm Type
Experimental
Arm Description
Patients were treated with an effective lowest concentration of CO2 delivered by the novel CO2 supply system.
Intervention Type
Device
Intervention Name(s)
novel device with a comfortable mask
Intervention Description
Using a device with a comfortable mask to supply constant low dose CO2 to treat patients.
Primary Outcome Measure Information:
Title
Apnea Hypopnea Index
Description
Total number of apneas and hypopneas/total sleep time (h)
Time Frame
One full night
Title
Central sleep apnea index
Description
Total number of central sleep apneas/total sleep time (h)
Time Frame
One full night
Title
Arousal Index
Description
Total number of arousals/total sleep time(h)
Time Frame
One full night
Title
Oxygen Desaturation Index
Description
Total number of oxygen desaturations≥3% /total sleep time(h)
Time Frame
One full night
Title
Sleep structure
Description
Assessment of the sleep efficiency (percentage is calculated by dividing Total Sleep Time by Total Time in bed)
Time Frame
One full night
Title
Sleep structure
Description
Assessment of the sleep stage distribution (percentage calculated by diving the time of stage N1, N2, N3, NREM by total sleep time)
Time Frame
One full night
Title
Adverse effects
Description
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.
Time Frame
One full night

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
82 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yuanming Luo, PhD
Organizational Affiliation
The First Affiliated Hospital of Guangzhou Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The First Affiliated Hospital of Guangzhou Medical University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510230
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Central Sleep Apnea Treated by CO2 Supplied by a Novel Device

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