Central Sleep ApneaNCT04907058
Central Sleep Apnea Treated by CO2 Supplied by a Novel Device
A study testing novel device with a comfortable mask in people with Central Sleep Apnea, run by State Key Laboratory of Respiratory Disease at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 82 years
- Conditions the study is for
- Central Sleep Apnea
- What is being tested?
- novel device with a comfortable mask
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteChina
- Study dates
- 20 May 2021to 23 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 82 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Obstructive sleep apnea
- Severe COPD，FEV1/FVC<70% and FEV1<60%
- Chronic CO2 retention with unknown reason
- Severe nasal congestion
- Poor understanding
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510230
About this study
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.
Read the 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.
- Conditions
- Central Sleep Apnea
- Being tested
- novel device with a comfortable mask
- Keywords
- CSA
- Medical subject headings
- Sleep Apnea, Central
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
novel device with a comfortable maskDevice
Using a device with a comfortable mask to supply constant low dose CO2 to treat patients.
| Study group | Role | What they receive |
|---|---|---|
| Treatment with CO2 | Experimental | Patients were treated with an effective lowest concentration of CO2 delivered by the novel CO2 supply system. Receives: Device: novel device with a comfortable mask |
What is being measured
The primary outcome is the main question the study is designed to answer.
Apnea Hypopnea Index
Total number of apneas and hypopneas/total sleep time (h)
Measured: One full night
Central sleep apnea index
Total number of central sleep apneas/total sleep time (h)
Measured: One full night
Arousal Index
Total number of arousals/total sleep time(h)
Measured: One full night
Oxygen Desaturation Index
Total number of oxygen desaturations≥3% /total sleep time(h)
Measured: One full night
Sleep structure
Assessment of the sleep efficiency (percentage is calculated by dividing Total Sleep Time by Total Time in bed)
Measured: 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)
Measured: 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.
Measured: One full night
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2021
- Study start20 May 2021
- Primary completion30 Aug 2021
- Study completion23 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Central Sleep ApneaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- State Key Laboratory of Respiratory Disease
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yuan-Ming Luo, State Key Laboratory of Respiratory Disease
- Investigators
- Yuanming Luo, PhD, Principal investigator, The First Affiliated Hospital of Guangzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04907058
- Sponsor's protocol ID
- 202037
- Status last verified
- Mar 2022
- First submitted
- 20 May 2021
- Last updated
- 31 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Central Sleep Apnea Treated by CO2 Supplied by a Novel Device
- ClinicalTrials.gov ID
- NCT04907058
- Acronym / sponsor ID
- 202037
- Conditions
- Central Sleep Apnea
- Keywords
- CSA
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- State Key Laboratory of Respiratory DiseaseUniversity, hospital or other
- Study start
- 20 May 2021 (actual)
- Primary completion
- 30 Aug 2021 (actual)
- Study completion
- 23 Sep 2021 (actual)
- First posted
- 28 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment with CO2 | Experimental | Device: novel device with a comfortable maskPatients were treated with an effective lowest concentration of CO2 delivered by the novel CO2 supply system. |
Who may qualify
- Ages
- 18 to 82 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- Obstructive sleep apnea
- Severe COPD，FEV1/FVC<70% and FEV1<60%
- Chronic CO2 retention with unknown reason
- Severe nasal congestion
- Poor understanding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| novel device with a comfortable maskUsing a device with a comfortable mask to supply constant low dose CO2 to treat patients. | Device | Treatment with CO2 |
Primary outcome
Apnea Hypopnea Index
Time frame: One full night
Total number of apneas and hypopneas/total sleep time (h)
Central sleep apnea index
Time frame: One full night
Total number of central sleep apneas/total sleep time (h)
Arousal Index
Time frame: One full night
Total number of arousals/total sleep time(h)
Oxygen Desaturation Index
Time frame: One full night
Total number of oxygen desaturations≥3% /total sleep time(h)
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)
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)
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2022.
- Individual participant dataSharing planned: Undecided
Related trials for Central Sleep Apnea
RecruitingObservational study
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Supplemental Oxygen for Sleep-Disordered Breathing in Adults With Chronic Opioid Use.
Sleep-disordered Breathing, Chronic Opioid Use
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Orthognathic Surgery and Obstructive Sleep Apnea Assessed by Mandibular Jaw Movement Monitoring (SUNRISE-ORTHO)
Obstructive Sleep Apnea, Sleep Apnea, Obstructive
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Registry of Central Sleep Apnea Patients Undergoing remedē System Implant
Central Sleep Apnea (Diagnosis), Central Sleep Apnea Syndrome
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yuanming Luo, PhD principal investigator
The First Affiliated Hospital of Guangzhou Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing novel device with a comfortable mask in people with Central Sleep Apnea, run by State Key Laboratory of Respiratory Disease at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Apnea Hypopnea Index (time frame: One full night). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2022.