View Clinical Trial (Medical Research Study)
Towards a Blood Test for Diagnosis of Obstructive Sleep Apnea
| City: |
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Philadelphia |
| State: |
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Pennsylvania |
| Zip Code: |
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19104 |
| Conditions: |
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Obstructive Sleep Apnea (OSA) |
| Purpose: |
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The purpose of the study is to:
- recruit subjects with untreated sleep apnea; assess overnight changes in their blood
and urine chemicals
- review the overnight changes in blood and urine chemicals after they have been treated
for sleep apnea
- assess the overnight changes in blood and urine chemicals in healthy individuals with
no sleep problems
- compare the amount of fat in the belly using a Magnetic Resonance Imaging (MRI) scanner
on all subjects
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| Study Summary: |
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The overall goal of this project is to address the postulate that the optimal molecular
signature for the common disorder obstructive sleep apnea (OSA) is change in relevant
biomarkers during the sleep period. In sleep apnea, events lead to sleep fragmentation and
cyclical deoxygenation/reoxygenation. It is proposed that these changes will lead to
molecular consequences can be detected by assessing biomarkers in blood. To determine which
changes are due to OSA and which to circadian/sleep mechanisms, studies will be done in
patients with OSA before and after effective treatment with CPAP and also in controls of
similar visceral adiposity without OSA. Multiple assessments of biomarkers will be made
before, during and after sleep. Since it is proposed that the magnitude of these dynamic
changes across the sleep period will be affected by degree of visceral obesity and be
greater in OSA subjects with cardiovascular comorbidities, studies will be done in 4 groups
of subjects: lean and obese with and without such morbidities. In assessing biomarkers the
primary outcome variables will be: urinary isoprostanes (oxidative stress); plasma TNFα
(inflammation); plasma norepinephrine (sympathetic activation); and free fatty acids.
Secondary biomarkers will be: IL-6, urinary norepinephrine; urinary normetanephrine;
glucose, ICAM, leptin. To complement assessment of circulating biomarkers, an approach
utilizing a cellular window will be used. Monocytes will be separated from each blood sample
(before, during and after sleep) and RNA extracted. Expression of key genes will be assessed
by RT-PCR and microarray studies will be performed in a subset of subjects to assess changes
in expression of all genes as a result of OSA. A particular focus will be investigating
differences between individuals with OSA with and without cardiovascular comorbidities.
Three aspects will be evaluated: a)whether individuals with comorbidities have more
oxidative stress and inflammatory change for equivalent degrees of OSA than individuals
without such comorbidities; b) whether individuals with comorbidities have lower levels of
protective mechanisms—melatonin (an anti-oxidant secreted during sleep), IL-10
(antiinflammatory); c) different gene variants based on a genetic association study using a
recently developed CV SNP array. Finally, data will be used to determine whether there is a
diagnostic urine and/or blood test for OSA.
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| Criteria: |
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Inclusion Criteria:
- able to read and write in English
- if female, not pregnant
- goes to bed between 9:30pm-12:30am and sleeps minimum of 7 hours/night
- has telephone access
- BMI < 40
Exclusion Criteria:
- shift worker, irregular schedule
- previous diagnosis of sleep disorder other than OSA
- previous treatment with CPAP, BiPAP, oxygen, surgery for OSA
- current kidney disease, anemia, depression,
- substance abuse/dependence
- BMI > 40
- visual/hearing/cognitive impairments
- smoker who's not willing to refrain from all nicotine during study
- not willing to try CPAP treatment
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| NCT ID: |
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NCT00834509 |
| Primary Contact: |
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Colleen Walsh, MS
Phone: 215-662-3189
Email: colleen.walsh@uphs.upenn.edu
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| Backup Contact: |
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Email: fran.pack@uphs.upenn.edu
Frances Pack, RN
Phone: 215-614-1807
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| Location Contact: |
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Philadelphia, Pennsylvania 19104
United States
There is no listed contact information for this specific location.
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 23, 2013 |
| Modifications to this listing: |
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