Obstructive Sleep ApneaNCT00287638
Markers in Exhaled Breath Condensate in Obstructive Sleep Apnoea (OSA) Patients
A study testing CPAP in people with Obstructive Sleep Apnea, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
Patients with obstructive sleep apnoea (OSA) have repetitive episodes of partial or complete upper airway obstruction during sleep. This leads to sleep fragmentation and symptoms like excessive daytime sleepiness and impaired psychosocial well-being. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- CPAP
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteHong Kong
- Study dates
- Jan 2006to Jan 2010
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients will be recruited upon admission for sleep study under the Division of Respiratory Medicine, Prince of Wales Hospital.
- Patients who are aged 18 to 60 will be recruited.
Who cannot join
- Known history of respiratory disease that will affect inflammatory markers in EBC like asthma, chronic obstructive pulmonary disease and bronchiectasis.
- Upper or lower respiratory tract infection within 6 weeks from the study.
- Current smokers, or ex-smoker who quitted for less than a year.
- Pregnant subjects.
- Any form of malignancies or serious medical illness that will affect the survival of the subject significantly in 1 year period.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: To Assess the Differences in Chemokines and Oxidative Stress Markers in Exhaled Breath Condensate of Obstructive Sleep Apnoea Patients
Patients with obstructive sleep apnoea (OSA) have repetitive episodes of partial or complete upper airway obstruction during sleep. This leads to sleep fragmentation and symptoms like excessive daytime sleepiness and impaired psychosocial well-being. More evidence now suggested OSA is associated with cardiovascular diseases like hypertension, myocardial infarction, pulmonary hypertension and stroke.
The upper airway structure and function are altered in OSA. Some studies suggested that an increase in the levels of systemic biomarkers of inflammation and oxidative stress in patients with OSA. So far, there is only very limited data on non-invasive monitoring of inflammation involved in the upper airway of OSA patients. The inflammatory mechanisms involved in the upper airway may give some insights to the systemic effect, like cardiovascular complications, of OSA.
Read more
Measurement of the constituents of exhaled breath and exhaled breath condensate (EBC) is a non-invasive method to assess the degree of inflammation of the airway. Exhaled nitric oxide (eNO) can be measured with the subject exhaling to a mouthpiece connected to a machine measuring real-time eNO level. With the subject exhaling to a cooling unit, EBC can be collected as liquid is formed as a result of condensation.
This study will assess the eNO in exhaled breath, oxidative stress marker (8-isoprostane) and cellular inflammatory markers (eotaxin, monocyted derived chemokine, growth related oncogene- alpha, monocyte chemoattractant protein-1) in the EBC and blood of OSA patients before and after 1 night and 3 months of continuous positive airway pressure treatment.
Read the detailed description
Measurement of exhaled Nitric Oxide and collection of exhaled breath condensate and peripheral blood. This will be done 2 to 4 times(on admission,the morning after sleep study,immediately after CPAP titration, after CPAP use for 3 months). Each time eNO will be measured first, followed by EBC collection.
For the tests in the morning, patients will be asked to postpone his/her breakfast until after the test which will take less than half an hour.
OSA is defined as patients having a respiratory disturbance index of ≥5/hr.
Measurement of Exhaled Nitric Oxide:
eNO will be measured using a Sievers 280i chemiluminescence analyser (Sievers Instruments, Boulder, CO, USA) sensitive to NO from 1 ppb to 200 ppm and with a resolution of 1 ppb and accuracy of 1 ppb designed for online recording. The eNO measurement will be performed according to ATS standards. Briefly, subjects should remain seated without nose clip during the procedure, with 2-minute rest between eNO measurements. The eNO will be measured online at an expiratory flow rate of 50 ml/sec, a dead space of 10 ml and 2-second plateau duration. Repeated exhalations are performed until three NO plateau values agree at the 10% level or two agree at the 5% level. The mean NO value will then be recorded.
Collection of Exhaled Breath Condensate:
EBC will be collected using the ECoscreen (Jaeger, Germany) according to manufacturer instructions. After rinsing their mouth, the recruited subjects will breathe tidally through a mouthpiece that is connected through a unique one-way valve into a cooled collection tube where vapours, aerosols and moisture in the breath condense along the walls of the tube. The one-way valve is then used as a plunger that collects droplets stuck to the inside wall and holds the sample near the top of the tube. The device inherently prevents salivary contamination as shown by the absence of salivary amylase in EBC. On average, this device will be able to collect 300 microL per minute of EBC for an adult. Each subject will be asked to breathe through the collection kit for 5 minutes, which should be sufficiently long to yield 1 ml of condensate for inflammatory marker analysis. EBC will be stored immediately at -70oC until analysis for inflammatory markers.
Measurement of 8 isoprostane, GRO alpha, MCP1, eotaxin and MDC levels in exhaled breath condensate:
EBC stored at -70oC will be analysed for 8-isoprostane, GROalpha, MCP1, eotaxin and MDC levels concentrations in batches. We will use 96-well polystyrene microplates coated with murine monoclonal antibodies against human 8 isoprostane, GRO alpha, MCP1, eotaxin and MDC levels. The levels of these markers in EBC will be measured in duplicates by sandwich enzyme immunoassay (R \& D Systems, Minneapolis, MN, USA) according to instructions provided by the manufacturer.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- CPAP, placebo
- Keywords
- Obstructive sleep apnea
- 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
Continuous positive pressure device with a time clock
placeboDevice
no CPAP
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | CPAP Receives: Device: CPAP |
| 2 | Placebo comparator | no CPAP Receives: Device: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in the biomarkers in breath over a period of time in subjects with CPAP and no CPAP treatment for the OSA
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 posted7 Feb 2006 (estimated)
- Study startJan 2006
- Primary completionJan 2010
- Study completionJan 2010
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.
- 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Investigators
- Fanny WS Ko, MBChB, Principal investigator, CUHK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00287638
- Sponsor's protocol ID
- Resp/ko/2006/002
- Status last verified
- Jan 2010
- First submitted
- 6 Feb 2006
- Last updated
- 22 Jan 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Assess the Differences in Chemokines and Oxidative Stress Markers in Exhaled Breath Condensate of Obstructive Sleep Apnoea Patients
- ClinicalTrials.gov ID
- NCT00287638
- Acronym / sponsor ID
- Resp/ko/2006/002
- Conditions
- Obstructive Sleep Apnea
- Keywords
- Obstructive sleep apnea
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- Jan 2006
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 7 Feb 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.
Patients with obstructive sleep apnoea (OSA) have repetitive episodes of partial or complete upper airway obstruction during sleep. This leads to sleep fragmentation and symptoms like excessive daytime sleepiness and impaired psychosocial well-being. More evidence now suggested OSA is associated with cardiovascular diseases like hypertension, myocardial infarction, pulmonary hypertension and stroke.
The upper airway structure and function are altered in OSA. Some studies suggested that an increase in the levels of systemic biomarkers of inflammation and oxidative stress in patients with OSA. So far, there is only very limited data on non-invasive monitoring of inflammation involved in the upper airway of OSA patients. The inflammatory mechanisms involved in the upper airway may give some insights to the systemic effect, like cardiovascular complications, of OSA.
Measurement of the constituents of exhaled breath and exhaled breath condensate (EBC) is a non-invasive method to assess the degree of inflammation of the airway. Exhaled nitric oxide (eNO) can be measured with the subject exhaling to a mouthpiece connected to a machine measuring real-time eNO level. With the subject exhaling to a cooling unit, EBC can be collected as liquid is formed as a result of condensation.
This study will assess the eNO in exhaled breath, oxidative stress marker (8-isoprostane) and cellular inflammatory markers (eotaxin, monocyted derived chemokine, growth related oncogene- alpha, monocyte chemoattractant protein-1) in the EBC and blood of OSA patients before and after 1 night and 3 months of continuous positive airway pressure treatment.
Detailed description
Measurement of exhaled Nitric Oxide and collection of exhaled breath condensate and peripheral blood. This will be done 2 to 4 times(on admission,the morning after sleep study,immediately after CPAP titration, after CPAP use for 3 months). Each time eNO will be measured first, followed by EBC collection.
For the tests in the morning, patients will be asked to postpone his/her breakfast until after the test which will take less than half an hour.
OSA is defined as patients having a respiratory disturbance index of ≥5/hr.
Measurement of Exhaled Nitric Oxide:
eNO will be measured using a Sievers 280i chemiluminescence analyser (Sievers Instruments, Boulder, CO, USA) sensitive to NO from 1 ppb to 200 ppm and with a resolution of 1 ppb and accuracy of 1 ppb designed for online recording. The eNO measurement will be performed according to ATS standards. Briefly, subjects should remain seated without nose clip during the procedure, with 2-minute rest between eNO measurements. The eNO will be measured online at an expiratory flow rate of 50 ml/sec, a dead space of 10 ml and 2-second plateau duration. Repeated exhalations are performed until three NO plateau values agree at the 10% level or two agree at the 5% level. The mean NO value will then be recorded.
Collection of Exhaled Breath Condensate:
EBC will be collected using the ECoscreen (Jaeger, Germany) according to manufacturer instructions. After rinsing their mouth, the recruited subjects will breathe tidally through a mouthpiece that is connected through a unique one-way valve into a cooled collection tube where vapours, aerosols and moisture in the breath condense along the walls of the tube. The one-way valve is then used as a plunger that collects droplets stuck to the inside wall and holds the sample near the top of the tube. The device inherently prevents salivary contamination as shown by the absence of salivary amylase in EBC. On average, this device will be able to collect 300 microL per minute of EBC for an adult. Each subject will be asked to breathe through the collection kit for 5 minutes, which should be sufficiently long to yield 1 ml of condensate for inflammatory marker analysis. EBC will be stored immediately at -70oC until analysis for inflammatory markers.
Measurement of 8 isoprostane, GRO alpha, MCP1, eotaxin and MDC levels in exhaled breath condensate:
EBC stored at -70oC will be analysed for 8-isoprostane, GROalpha, MCP1, eotaxin and MDC levels concentrations in batches. We will use 96-well polystyrene microplates coated with murine monoclonal antibodies against human 8 isoprostane, GRO alpha, MCP1, eotaxin and MDC levels. The levels of these markers in EBC will be measured in duplicates by sandwich enzyme immunoassay (R \& D Systems, Minneapolis, MN, USA) according to instructions provided by the manufacturer.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Device: CPAPCPAP |
| 2 | Placebo comparator | Device: placebono CPAP |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Patients will be recruited upon admission for sleep study under the Division of Respiratory Medicine, Prince of Wales Hospital.
- Patients who are aged 18 to 60 will be recruited.
Key exclusion criteria (5 listed)
- Known history of respiratory disease that will affect inflammatory markers in EBC like asthma, chronic obstructive pulmonary disease and bronchiectasis.
- Upper or lower respiratory tract infection within 6 weeks from the study.
- Current smokers, or ex-smoker who quitted for less than a year.
- Pregnant subjects.
- Any form of malignancies or serious medical illness that will affect the survival of the subject significantly in 1 year period.
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 |
|---|---|---|
| CPAPContinuous positive pressure device with a time clock | Device | 1 |
| placebono CPAP | Device | 2 |
Primary outcome
Changes in the biomarkers in breath over a period of time in subjects with CPAP and no CPAP treatment for the OSA
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 22 Jan 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.
Fanny WS Ko, MBChB principal investigator
CUHK
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 Obstructive Sleep Apnea, run by Chinese University of Hong Kong at 1 site in Hong Kong.
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 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 22 Jan 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 Hong Kong. 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. Some participants in this study may receive a placebo. 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?
Changes in the biomarkers in breath over a period of time in subjects with CPAP and no CPAP treatment for the OSA (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 22 Jan 2010.