Sleep Apnea, ObstructiveNCT00491088
The CPAP Effect in Severe Obstructive- Sleep- Apnea Patients Without Daytime Sleepiness: A Control Randomized Trial
A study testing CPAP in people with Sleep Apnea, Obstructive, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Specific Aim: 1. To prove our hypothesis that in severe OSA patients without daytime sleepiness, CPAP worked as effectively as in severe OSA patients with daytime sleepiness. Using sham CPAP as the optimal placebo, we conduct a randomized double-blind placebo controlled trial to assess the CPAP effect in severe OSA… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Sleep Apnea, Obstructive
- What is being tested?
- CPAP
- Type of treatment
- Medical device
- How many people
- 96 participants
- Where
- 1 siteTaiwan
- Study dates
- Jun 2007to Dec 2009
- 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 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Severe obstructive sleep apnea (AHI>=30/hr) age, sex, BMI match control subject
Who cannot join
- Patients were excluded when they:
- Refused to participate in this study
- Had severe obstructive pulmonary disease or active neurological events
- Enrolled in other studies at the same time
Trial locations and contacts
1 site in 1 country.
About this study
Specific Aim:
- To prove our hypothesis that in severe OSA patients without daytime sleepiness, CPAP worked as effectively as in severe OSA patients with daytime sleepiness. Using sham CPAP as the optimal placebo, we conduct a randomized double-blind placebo controlled trial to assess the CPAP effect in severe OSA patients without daytime sleepiness.
- To establish a model to predict the CPAP effect We use the parameters of five aspects, including changes of polysomnographic parameters, improvement of sleepiness, fatigue and QOL, sympathetic activity, inflammatory mediators and metabolism, to establish a model to predict CPAP effect.
Read the detailed description
Obstructive sleep apnea (OSA) is a common disease, which affects 4% middle-aged men and 2% women. Daytime sleepiness is one of the symptoms of OSA which drive patients to seek medical help. Sleepiness in OSA has been reported to be raised by microarousal, altered sleep structure and somnogenic cytokine and modifications in body metabolism. The assessments of daytime sleepiness included objective measures, like multiple sleep latency test and subjective measures, like Epworth sleepiness scale (ESS).
So far, continuous positive airway pressure (CPAP) is the standard treatment for patients with severe OSA. CPAP could improve daytime wakefulness, blood pressure and quality of life (QOL). Several studies tried to identify factors predicting the CPAP effect and most concluded CPAP was not effective for patients with high apnea-hypopnea index but not sleepy. All of them determine the CPAP effect in terms of daytime function, lowering of blood pressure and QOL. None of these studies evaluate the CPAP effects in terms of improvement of sympathetic hyperactivity, inflammatory mediators and metabolic abnormalities. Therefore, we assumed patients whose daytime functions didn't improve after CPAP treatment still possibly got benefit from altering factors contributing to cardiovascular consequences.
Our previous study showed that CPAP effect in OSA patients without sleepiness was as well as in patients with sleepiness, except that plasma level of norepinephrine and 24hr mean arterial blood pressure could be lowered more in patients with sleepiness. However, without optimal placebo and randomization, the actual role of CPAP in treating non-sleepy OSA patients still couldn't be determined.
Recently sham CPAP was developed, which mimicked all the characteristics of a true CPAP except for the null pressure applied to the upper airway of the patient. Moreover, sham CPAP doesn't influence sleep efficiency, arousals, or apnea-hypopnea index. Therefore, in this project, using sham CPAP as a placebo, we propose a randomized double-blind placebo controlled trial to assess the effectiveness of CPAP in severe OSA patients without daytime sleepiness. We also establish a model to predict the CPAP effect. The results would change the current practice of managing severe OSA patients without daytime sleepiness.
- Conditions
- Sleep Apnea, Obstructive
- Being tested
- 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.
CPAPDevice
CPAP for 12 weeks
What is being measured
The primary outcome is the main question the study is designed to answer.
improvement of sleepiness
Measured: after 4-week and 12-week CPAP treatment
Secondary outcomes (1)
improvement of fatigue and QOL, sympathetic activity, inflammatory mediators and metabolism
Measured: after 4-week and 12-week CPAP treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2007 (estimated)
- Study startJun 2007
- Primary completionAug 2009
- Study completionDec 2009
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.
- More trials run by National Taiwan University HospitalThe 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Whey Dong Wu, M.D., Principal investigator, National Taiwan University HospitalPeilin Lee, M.D., Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00491088
- Sponsor's protocol ID
- 200701063R
- Status last verified
- Feb 2010
- First submitted
- 21 Jun 2007
- Last updated
- 1 Mar 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The CPAP Effect in Severe Obstructive- Sleep- Apnea Patients Without Daytime Sleepiness: A Control Randomized Trial
- ClinicalTrials.gov ID
- NCT00491088
- Acronym / sponsor ID
- 200701063R
- Conditions
- Sleep Apnea, Obstructive
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Jun 2007
- Primary completion
- Aug 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 25 Jun 2007 (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.
Specific Aim:
- To prove our hypothesis that in severe OSA patients without daytime sleepiness, CPAP worked as effectively as in severe OSA patients with daytime sleepiness. Using sham CPAP as the optimal placebo, we conduct a randomized double-blind placebo controlled trial to assess the CPAP effect in severe OSA patients without daytime sleepiness.
- To establish a model to predict the CPAP effect We use the parameters of five aspects, including changes of polysomnographic parameters, improvement of sleepiness, fatigue and QOL, sympathetic activity, inflammatory mediators and metabolism, to establish a model to predict CPAP effect.
Detailed description
Obstructive sleep apnea (OSA) is a common disease, which affects 4% middle-aged men and 2% women. Daytime sleepiness is one of the symptoms of OSA which drive patients to seek medical help. Sleepiness in OSA has been reported to be raised by microarousal, altered sleep structure and somnogenic cytokine and modifications in body metabolism. The assessments of daytime sleepiness included objective measures, like multiple sleep latency test and subjective measures, like Epworth sleepiness scale (ESS).
So far, continuous positive airway pressure (CPAP) is the standard treatment for patients with severe OSA. CPAP could improve daytime wakefulness, blood pressure and quality of life (QOL). Several studies tried to identify factors predicting the CPAP effect and most concluded CPAP was not effective for patients with high apnea-hypopnea index but not sleepy. All of them determine the CPAP effect in terms of daytime function, lowering of blood pressure and QOL. None of these studies evaluate the CPAP effects in terms of improvement of sympathetic hyperactivity, inflammatory mediators and metabolic abnormalities. Therefore, we assumed patients whose daytime functions didn't improve after CPAP treatment still possibly got benefit from altering factors contributing to cardiovascular consequences.
Our previous study showed that CPAP effect in OSA patients without sleepiness was as well as in patients with sleepiness, except that plasma level of norepinephrine and 24hr mean arterial blood pressure could be lowered more in patients with sleepiness. However, without optimal placebo and randomization, the actual role of CPAP in treating non-sleepy OSA patients still couldn't be determined.
Recently sham CPAP was developed, which mimicked all the characteristics of a true CPAP except for the null pressure applied to the upper airway of the patient. Moreover, sham CPAP doesn't influence sleep efficiency, arousals, or apnea-hypopnea index. Therefore, in this project, using sham CPAP as a placebo, we propose a randomized double-blind placebo controlled trial to assess the effectiveness of CPAP in severe OSA patients without daytime sleepiness. We also establish a model to predict the CPAP effect. The results would change the current practice of managing severe OSA patients without daytime sleepiness.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Severe obstructive sleep apnea (AHI>=30/hr) age, sex, BMI match control subject
Key exclusion criteria (4 listed)
- Refused to participate in this study
- Had severe obstructive pulmonary disease or active neurological events
- Enrolled in other studies at the same time
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 |
|---|---|---|
| CPAPCPAP for 12 weeks | Device | – |
Primary outcome
improvement of sleepiness
Time frame: after 4-week and 12-week CPAP treatment
1 secondary outcome
improvement of fatigue and QOL, sympathetic activity, inflammatory mediators and metabolism
Time frame: after 4-week and 12-week CPAP 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 1 Mar 2010.
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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.
Whey Dong Wu, M.D. principal investigator
National Taiwan University Hospital
Peilin Lee, M.D. principal investigator
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CPAP in people with Sleep Apnea, Obstructive, run by National Taiwan University Hospital at 1 site in Taiwan.
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 1 inclusion and 4 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 1 Mar 2010. 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 Taiwan. 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?
improvement of sleepiness (time frame: after 4-week and 12-week CPAP treatment). 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 1 Mar 2010; AzTrials last refreshed its copy on 1 Nov 2026.