Ignite Creation Date:
2024-05-05 @ 4:37 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00287638
Status:
COMPLETED
Last Update Posted:
2010-01-22
First Post:
2006-02-06
Brief Title:
Markers in Exhaled Breath Condensate in Obstructive Sleep Apnoea OSA Patients
Sponsor:
Chinese University of Hong Kong
Organization:
Chinese University of Hong Kong
Study Overview
Official Title:
To Assess the Differences in Chemokines and Oxidative Stress Markers in Exhaled Breath Condensate of Obstructive Sleep Apnoea Patients
Status:
COMPLETED
Status Verified Date:
2010-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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
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 timeson admissionthe morning after sleep studyimmediately 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 hisher breakfast until after the test which will take less than half an hour
OSA is defined as patients having a respiratory disturbance index of 5hr
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 mlsec 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
For the tests in the morning patients will be asked to postpone hisher breakfast until after the test which will take less than half an hour
OSA is defined as patients having a respiratory disturbance index of 5hr
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 mlsec 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None