Sleep Apnea, ObstructiveNCT03782844
Efficacy of Simple Continuous Positive Airway Pressure on Patients With Obstructive Sleep Apnea
A study testing Simple CPAP+Conventional fixed CPAP and Simple CPAP + Auto CPAP in people with Sleep Apnea, Obstructive and Continuous Positive Airway Pressure, run by State Key Laboratory of Respiratory Disease at 1 site in China.
Trial summary
Obstructive sleep apnea (OSA) is a common and frequently-occurring disease. The incidence of OSA is more than 4% in general population, and as high as 20% - 40% in the elderly. At present, CPAP machines commonly used for OSA treatment includes traditional pressure fixed single-level CPAP machine and automatic pressure… Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Sleep Apnea, Obstructive, Continuous Positive Airway Pressure, Polysomnography
- What is being tested?
- Simple CPAP+Conventional fixed CPAP and Simple CPAP + Auto CPAP
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 2 Jan 2019to 15 Oct 2019
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, 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 OSA with an apnoea-hypopnoea- index (AHI)≥5/h by overnight polysomnography
Who cannot join
- Central Sleep Apnoea/Cheyne Stokes Respiration
- Opioid or sedative use; Alcohol abuse
- Nasal congestion or tonsils more than Ⅱ degrees enlarged
- Optimal treatment CPAP pressure over 10cmH2O
- Poor understanding or being disabled
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong
About this study
Obstructive sleep apnea (OSA) is a common and frequently-occurring disease. The incidence of OSA is more than 4% in general population, and as high as 20% - 40% in the elderly. At present, CPAP machines commonly used for OSA treatment includes traditional pressure fixed single-level CPAP machine and automatic pressure regulation CPAP machine. Studies have shown that the CPAP treatment pressure of OSA patients is normally below 11 cmH2O. Since the condition of OSA patients and the required CPAP treatment pressure may change over time, a CPAP machine with automatic pressure regulation function may theoretically better meet the needs of treatment. However, a recent large-scale clinical study with an average follow-up of four years showed that there was little need to change CPAP treatment pressure after titration. Although different types of CPAP have different functions, the basic principle is to keep the upper airway open and unobstructed to eliminate sleep apnea and hypopnea by continuously applying positive pressure to the upper respiratory tract through an air pump. A complex CPAP machine with functions such as pressure regulation, boost delay, end-expiratory pressure release will cost more than a single-function CPAP machine. Some patients from poor areas, even with severe OSA, may give up treatment when they can not afford CPAP machines that have not yet been included in national health insurance in China. In view of the current economic level in China, it is urgent to find an inexpensive and effective CPAP machine for the treatment of OSA and related complications. Recently, Guangzhou Yinghui Medical Technology Co., Ltd.and State Key Laboratory of Respiratory Disease have developed a new simple CPAP machine. The CPAP treatment pressure is fixed at the factory to 6 cm H2O (SKL), 8 cm H2O (SKM) and 10 cm H2O (SKH). Compared to traditional CPAP machine, only a power switch button is attached on the body, and the additional adjustment devices including display screen are removed, which not only reduces the cost of the CPAP machine, but also facilitates the operation of patients.
Read the detailed description
Study Design: A randomized, cross-over and double blind study . Objective: To investigate the efficacy of simple device of continuous positive airway pressure (CPAP) in the treatment of obstructive sleep apnea (OSA). Methods: A randomized, cross-over and double blind study would be performed on 100 OSA patients using both simple CPAP and traditional CPAP during overnight polysomnography. Pressure for CPAP treatment would be manual titrated. The sleep apnea hypopnea index (AHI), arousal index (ArI), Oxygen desaturation Index (ODI), sleep structure and the preference of CPAP model were to be observed.
- Being tested
- Simple CPAP+Conventional fixed CPAP, Simple CPAP + Auto CPAP
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Simple CPAP+Conventional fixed CPAPDevice
Patients used simple CPAP and conventional fixed CPAP during overnight polysomnography.
Simple CPAP + Auto CPAPDevice
Patients used simple CPAP and Auto CPAP during overnight polysomnography.
| Study group | Role | What they receive |
|---|---|---|
| Conventional fixed CPAP and simple CPAP | Experimental | Participants in this group were manually titrated . They were treated with conventional fixed pressure CPAP and Simple CPAP for two separate nights in random order monitored by full polysomnography. Receives: Device: Simple CPAP+Conventional fixed CPAP |
| Auto CPAP and simple CPAP | Experimental | Participants in this group after being manually titrated were treated with Auto RemStar CPAP and Simple CPAP for two separate nights in random order monitored by full polysomnography. Receives: Device: Simple CPAP + Auto CPAP |
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×60/total sleep time
Measured: One full night
Arousal Index
Total number of arousals×60/total sleep time
Measured: One full night
Oxygen Desaturation Index
Total number of oxygen desaturations≥3%×60/total sleep time
Measured: One full night
Sleep structure
Sleep stage distribution(N1, N2, N3, NREM)
Measured: One full night
Adverse effects
Using questionnaire to assess adverse effects including dyspnea, noise, bloating, et al
Measured: Onefull night
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2018
- Study start2 Jan 2019
- Primary completion1 Oct 2019
- Study completion15 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep Apnea, ObstructiveStudies 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
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03782844
- Sponsor's protocol ID
- 2011 No. 5
- Status last verified
- May 2021
- First submitted
- 5 Nov 2018
- Last updated
- 25 May 2021
- Results posted
- No
- 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 25 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Simple Continuous Positive Airway Pressure on Patients With Obstructive Sleep Apnea
- ClinicalTrials.gov ID
- NCT03782844
- Acronym / sponsor ID
- 2011 No. 5
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- State Key Laboratory of Respiratory DiseaseUniversity, hospital or other
- Study start
- 2 Jan 2019 (actual)
- Primary completion
- 1 Oct 2019 (actual)
- Study completion
- 15 Oct 2019 (actual)
- First posted
- 20 Dec 2018 (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.
Obstructive sleep apnea (OSA) is a common and frequently-occurring disease. The incidence of OSA is more than 4% in general population, and as high as 20% - 40% in the elderly. At present, CPAP machines commonly used for OSA treatment includes traditional pressure fixed single-level CPAP machine and automatic pressure regulation CPAP machine. Studies have shown that the CPAP treatment pressure of OSA patients is normally below 11 cmH2O. Since the condition of OSA patients and the required CPAP treatment pressure may change over time, a CPAP machine with automatic pressure regulation function may theoretically better meet the needs of treatment. However, a recent large-scale clinical study with an average follow-up of four years showed that there was little need to change CPAP treatment pressure after titration. Although different types of CPAP have different functions, the basic principle is to keep the upper airway open and unobstructed to eliminate sleep apnea and hypopnea by continuously applying positive pressure to the upper respiratory tract through an air pump. A complex CPAP machine with functions such as pressure regulation, boost delay, end-expiratory pressure release will cost more than a single-function CPAP machine. Some patients from poor areas, even with severe OSA, may give up treatment when they can not afford CPAP machines that have not yet been included in national health insurance in China. In view of the current economic level in China, it is urgent to find an inexpensive and effective CPAP machine for the treatment of OSA and related complications. Recently, Guangzhou Yinghui Medical Technology Co., Ltd.and State Key Laboratory of Respiratory Disease have developed a new simple CPAP machine. The CPAP treatment pressure is fixed at the factory to 6 cm H2O (SKL), 8 cm H2O (SKM) and 10 cm H2O (SKH). Compared to traditional CPAP machine, only a power switch button is attached on the body, and the additional adjustment devices including display screen are removed, which not only reduces the cost of the CPAP machine, but also facilitates the operation of patients.
Detailed description
Study Design: A randomized, cross-over and double blind study . Objective: To investigate the efficacy of simple device of continuous positive airway pressure (CPAP) in the treatment of obstructive sleep apnea (OSA). Methods: A randomized, cross-over and double blind study would be performed on 100 OSA patients using both simple CPAP and traditional CPAP during overnight polysomnography. Pressure for CPAP treatment would be manual titrated. The sleep apnea hypopnea index (AHI), arousal index (ArI), Oxygen desaturation Index (ODI), sleep structure and the preference of CPAP model were to be observed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional fixed CPAP and simple CPAP | Experimental | Device: Simple CPAP+Conventional fixed CPAPParticipants in this group were manually titrated . They were treated with conventional fixed pressure CPAP and Simple CPAP for two separate nights in random order monitored by full polysomnography. |
| Auto CPAP and simple CPAP | Experimental | Device: Simple CPAP + Auto CPAPParticipants in this group after being manually titrated were treated with Auto RemStar CPAP and Simple CPAP for two separate nights in random order monitored by full polysomnography. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Willing to participate after informed consent
- Males and females, any race and aged≥18yeras
- Objectively confirmed OSA with an apnoea-hypopnoea- index (AHI)≥5/h by overnight polysomnography
Key exclusion criteria (5 listed)
- Central Sleep Apnoea/Cheyne Stokes Respiration
- Opioid or sedative use; Alcohol abuse
- Nasal congestion or tonsils more than Ⅱ degrees enlarged
- Optimal treatment CPAP pressure over 10cmH2O
- Poor understanding or being disabled
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 |
|---|---|---|
| Simple CPAP+Conventional fixed CPAPPatients used simple CPAP and conventional fixed CPAP during overnight polysomnography. | Device | Conventional fixed CPAP and simple CPAP |
| Simple CPAP + Auto CPAPPatients used simple CPAP and Auto CPAP during overnight polysomnography. | Device | Auto CPAP and simple CPAP |
Primary outcome
Apnea Hypopnea Index
Time frame: One full night
Total number of apneas and hypopneas×60/total sleep time
Arousal Index
Time frame: One full night
Total number of arousals×60/total sleep time
Oxygen Desaturation Index
Time frame: One full night
Total number of oxygen desaturations≥3%×60/total sleep time
Sleep structure
Time frame: One full night
Sleep stage distribution(N1, N2, N3, NREM)
Adverse effects
Time frame: Onefull night
Using questionnaire to assess adverse effects including dyspnea, noise, bloating, et al
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 25 May 2021.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Simple CPAP+Conventional fixed CPAP and Simple CPAP + Auto CPAP in people with Sleep Apnea, Obstructive and Continuous Positive Airway Pressure, 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 25 May 2021. 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 5 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 25 May 2021.