Obstructive Sleep ApneaNCT00307424
Comparison Between Auto CPAP and Fixed CPAP in Chinese Patients With OSA
A study testing AutoCPAP and FixCPAP in people with Obstructive Sleep Apnea, run by Chinese University of Hong Kong at 2 sites in China.
Trial summary
AutoCPAP would lead to better compliance than FixCPAP Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- AutoCPAP and FixCPAP
- Type of treatment
- Medical device
- How many people
- Not given
- Where
- 2 sitesChina
- Study dates
- Aug 2004to Jun 2005
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All subjects should be CPAP naïve.
- OSA confirmed with sleep study
- Presence of daytime symptoms with excessive daytime sleepiness
- Age between 18 to 65
- RDI greater than 30
- Agreed to participate in trial with informed consent signed
Who cannot join
- Patients not suitable to nasal CPAP because of facial abnormality leading to poor mask fitting.
- Patients with known COPD with type II failure
- Patients with known heart failure.
- Patients with predominant central sleep apnea.
- Patients need bilevel positive airway pressure ventilation.
- Patients refusing to participate the trial.
- Patients have difficulty to follow up regularly.
- patients with untreated or under treatment of hypothyroidism
Trial locations and contacts
2 sites in 1 country.
China2 sites
North District Hospital
Hong Kong
Prince of Wales Hospital
Hong Kong
About this study
Official title: Comparison of Auto-Continuous Positive Airway Pressure Device(Auto-CPAP) With Conventional Fixed CPAP in Chinese Patients With Obstructive Sleep Apnea (OSA)
AutoCPAP would lead to better compliance than FixCPAP
Read the detailed description
A prospective, randomized crossover cohort. Study subjects consisted of patients newly diagnosed with obstructive sleep apnea (OSA) confirmed with sleep study. All are CPAP naïve.
Randomization:
Arm 1: auto CPAP sleep study then auto CPAP for 2 months Arm 2: fixed CPAP titration then fixed CPAP for 2 months
Then switch over to the other arm
Trial end after 4 months, compliance and other parameters would be compared between two arms as described in the endpoint session.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- AutoCPAP, FixCPAP
- 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.
AutoCPAPDevice
FixCPAPDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the compliance of auto-CPAP and fixed CPAP in terms of CPAP usage hours.
To compare the clinical efficacy of auto-CPAP and fixed CPAP in terms of pressure level to abolish OSA, Epworth sleepiness scale and quality of life questionnaire.
To compare patient acceptance of the different type of treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2006 (estimated)
- Study startAug 2004
- Study completionJun 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- 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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Investigators
- To K Wang, FHKCP, Principal investigator, Prince of Wales Hosptial
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00307424
- Sponsor's protocol ID
- CRE-2004.258-T
- Status last verified
- Aug 2004
- First submitted
- 27 Mar 2006
- Last updated
- 28 Mar 2006
- Results posted
- No
Publications
To KW, Chan WC, Choo KL, Lam WK, Wong KK, Hui DS. A randomized cross-over study of auto-continuous positive airway pressure versus fixed-continuous positive airway pressure in patients with obstructive sleep apnoea. Respirology. 2008 Jan;13(1):79-86. doi: 10.1111/j.1440-1843.2007.01138.x.
PubMed 18197915
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Auto-Continuous Positive Airway Pressure Device(Auto-CPAP) With Conventional Fixed CPAP in Chinese Patients With Obstructive Sleep Apnea (OSA)
- ClinicalTrials.gov ID
- NCT00307424
- Acronym / sponsor ID
- CRE-2004.258-T
- Conditions
- Obstructive Sleep Apnea
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- Aug 2004
- Study completion
- Jun 2005
- First posted
- 28 Mar 2006 (estimated)
- 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.
AutoCPAP would lead to better compliance than FixCPAP
Detailed description
A prospective, randomized crossover cohort. Study subjects consisted of patients newly diagnosed with obstructive sleep apnea (OSA) confirmed with sleep study. All are CPAP naïve.
Randomization:
Arm 1: auto CPAP sleep study then auto CPAP for 2 months Arm 2: fixed CPAP titration then fixed CPAP for 2 months
Then switch over to the other arm
Trial end after 4 months, compliance and other parameters would be compared between two arms as described in the endpoint session.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- All subjects should be CPAP naïve.
- OSA confirmed with sleep study
- Presence of daytime symptoms with excessive daytime sleepiness
- Age between 18 to 65
- RDI greater than 30
Key exclusion criteria (8 listed)
- Patients not suitable to nasal CPAP because of facial abnormality leading to poor mask fitting.
- Patients with known COPD with type II failure
- Patients with known heart failure.
- Patients with predominant central sleep apnea.
- Patients need bilevel positive airway pressure ventilation.
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 |
|---|---|---|
| AutoCPAP | Device | – |
| FixCPAP | Device | – |
Primary outcome
To compare the compliance of auto-CPAP and fixed CPAP in terms of CPAP usage hours.
To compare the clinical efficacy of auto-CPAP and fixed CPAP in terms of pressure level to abolish OSA, Epworth sleepiness scale and quality of life questionnaire.
To compare patient acceptance of the different type of treatment.
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 28 Mar 2006.
- Derived from this study: PubMed 18197915To KW, Chan WC, Choo KL, Lam WK, Wong KK, Hui DS. A randomized cross-over study of auto-continuous positive airway pressure versus fixed-continuous positive airway pressure in patients with obstructive sleep apnoea. Respirology. 2008 Jan;13(1):79-86. doi: 10.1111/j.1440-1843.2007.01138.x.
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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.
To K Wang, FHKCP principal investigator
Prince of Wales Hosptial
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AutoCPAP and FixCPAP in people with Obstructive Sleep Apnea, run by Chinese University of Hong Kong at 2 sites 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 6 inclusion and 8 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 28 Mar 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
To compare the compliance of auto-CPAP and fixed CPAP in terms of CPAP usage hours.. The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00307424, which also lists 1 linked publication.
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 28 Mar 2006.