Obstructive Sleep ApneaNCT00780923
Effect of Continuous Positive Airway Pressure Treatment on Inflammation in Patients With Obstructive Sleep Apnea
A study testing CPAP treatment in people with Obstructive Sleep Apnea and Inflammation, run by Kyoto University, Graduate School of Medicine at 1 site in Japan.
Trial summary
The purpose of this study is to evaluate the effects of CPAP treatment on airway and systemic inflammation in obstructive sleep apnea. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obstructive Sleep Apnea, Inflammation, Continuous Positive Airway Pressure
- What is being tested?
- CPAP treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteJapan
- Study dates
- Jan 2009to Mar 2011
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects on admission for sleep study under the Respiratory Care and Sleep Control Medicine, Kyoto University Hospital.
- Subjects diagnosed with OSA (apnea hypopnea index >=20/hour) by overnight polysomnography.
Who cannot join
- Known history of respiratory diseases that will affect airway inflammatory markers like asthma, chronic obstructive pulmonary disease and bronchiectasis.
- Treatments with corticosteroids or other immunosuppressive drugs.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Longitudinal Study of Short-Term Effects of CPAP Treatment on Airway and Systemic Inflammation in Patients With Obstructive Sleep Apnea
The purpose of this study is to evaluate the effects of CPAP treatment on airway and systemic inflammation in obstructive sleep apnea.
Read the detailed description
Obstructive sleep apnea (OSA) is characterised by repetitive episodes of upper airway obstruction during sleep. Systemic and airway inflammation has been recently shown to be associated with OSA and is hypothesized to contribute to the clinical manifestation and the complications of OSA patients.
Continuous positive airway pressure (CPAP) is a first-line treatment for OSA and improves diurnal and nocturnal symptoms. However, the effectiveness of CPAP in reversing airway inflammation is less compelling in comparison to systemic inflammation.
This study will assess NO in exhaled breath, inflammatory biomarkers in induced sputum and blood of OSA patients and other clinical measurements before and after 3 months of CPAP treatment.
- Being tested
- CPAP treatment
- Medical subject headings
- Sleep Apnea, Obstructive, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPAP treatmentDevice
Also called REMstar(Respironics), SleepMate(ResMed)
maintains upper airway patency and minimizes the obstructive events
| Study group | Role | What they receive |
|---|---|---|
| CPAP | Experimental | Not described Receives: Device: CPAP treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inflammatory biomarkers in induced sputum and blood. Cell counts in induced sputum.
Measured: 3 months
Secondary outcomes (6)
NO in exhaled breath
Measured: 3 months
Airway resistance
Measured: 3 months
PSG measurement(AHI,etc.)
Measured: 3 months
Quality of Life
Measured: 3 months
Psychological status
Measured: 3 months
Sleep quality
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2008 (estimated)
- Study startJan 2009
- Primary completionMar 2011
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kyoto University, Graduate School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Toru Oga, Kyoto University, Graduate School of Medicine
- Investigators
- Kazuo Chin, MD,PhD, Principal investigator, Kyoto University, Graduate School of MedicineToru Oga, MD,PhD, Principal investigator, Kyoto University, Graduate School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00780923
- Sponsor's protocol ID
- E-558
- Status last verified
- Mar 2013
- First submitted
- 27 Oct 2008
- Last updated
- 27 Mar 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Longitudinal Study of Short-Term Effects of CPAP Treatment on Airway and Systemic Inflammation in Patients With Obstructive Sleep Apnea
- ClinicalTrials.gov ID
- NCT00780923
- Acronym / sponsor ID
- E-558
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Kyoto University, Graduate School of MedicineUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 28 Oct 2008 (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.
The purpose of this study is to evaluate the effects of CPAP treatment on airway and systemic inflammation in obstructive sleep apnea.
Detailed description
Obstructive sleep apnea (OSA) is characterised by repetitive episodes of upper airway obstruction during sleep. Systemic and airway inflammation has been recently shown to be associated with OSA and is hypothesized to contribute to the clinical manifestation and the complications of OSA patients.
Continuous positive airway pressure (CPAP) is a first-line treatment for OSA and improves diurnal and nocturnal symptoms. However, the effectiveness of CPAP in reversing airway inflammation is less compelling in comparison to systemic inflammation.
This study will assess NO in exhaled breath, inflammatory biomarkers in induced sputum and blood of OSA patients and other clinical measurements before and after 3 months of CPAP treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CPAP | Experimental | Device: CPAP treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subjects on admission for sleep study under the Respiratory Care and Sleep Control Medicine, Kyoto University Hospital.
- Subjects diagnosed with OSA (apnea hypopnea index >=20/hour) by overnight polysomnography.
Key exclusion criteria (2 listed)
- Known history of respiratory diseases that will affect airway inflammatory markers like asthma, chronic obstructive pulmonary disease and bronchiectasis.
- Treatments with corticosteroids or other immunosuppressive drugs.
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 |
|---|---|---|
| CPAP treatmentAlso: REMstar(Respironics), SleepMate(ResMed)maintains upper airway patency and minimizes the obstructive events | Device | CPAP |
Primary outcome
Inflammatory biomarkers in induced sputum and blood. Cell counts in induced sputum.
Time frame: 3 months
6 secondary outcomes
NO in exhaled breath
Time frame: 3 months
Airway resistance
Time frame: 3 months
PSG measurement(AHI,etc.)
Time frame: 3 months
Quality of Life
Time frame: 3 months
Psychological status
Time frame: 3 months
Sleep quality
Time frame: 3 months
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 27 Mar 2013.
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Supplemental Oxygen for Sleep-Disordered Breathing in Adults With Chronic Opioid Use.
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Nightly Wearable Monitoring During Home-Based Submental Electrical Stimulation for Obstructive Sleep Apnea
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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.
Kazuo Chin, MD,PhD principal investigator
Kyoto University, Graduate School of Medicine
Toru Oga, MD,PhD principal investigator
Kyoto University, Graduate School of Medicine
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 treatment in people with Obstructive Sleep Apnea and Inflammation, run by Kyoto University, Graduate School of Medicine at 1 site in Japan.
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 2 inclusion and 2 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 27 Mar 2013. 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 Japan. 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?
Inflammatory biomarkers in induced sputum and blood. Cell counts in induced sputum. (time frame: 3 months). 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 27 Mar 2013.