Obstructive Sleep Apnea (OSA)BOSANCT00834509
Biomarkers for Obstructive Sleep Apnea
An observational study of Obstructive Sleep Apnea (OSA), run by University of Pennsylvania at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 30 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Obstructive Sleep Apnea (OSA)
- What is being tested?
- CPAP
- Type of treatment
- Medical device
- How many people
- 181 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2008to 1 Feb 2015
- Phase
- Observational
- 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 30 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: OSA patients with moderate to severe disease as confirmed by apnea-hypopnea index (AHI > 15) in a polysomnography. Healthy controls, both snorers and nonsnorers, with an apnea-hypopnea index (AHI < 5) in a polysomnography.
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- visual/hearing/cognitive impairments
- smoker who's not willing to refrain from all nicotine during study
- not willing to try CPAP treatment
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: Towards a Blood Test for Diagnosis of Obstructive Sleep Apnea
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
Read the detailed description
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 Continuous Positive Airway Pressure (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 tumor necrosis factor alpha (TNFα) (inflammation); plasma norepinephrine (sympathetic activation); and free fatty acids. Secondary biomarkers will be: Interleukin 6 (IL-6), urinary norepinephrine; urinary normetanephrine; glucose, Intercellular Adhesion Molecule (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.
- Conditions
- Obstructive Sleep Apnea (OSA)
- 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
Use CPAP for 4-6 weeks as clinically prescribed.
| Study group | Role | What they receive |
|---|---|---|
| Obstructive Sleep Apnea (OSA) | OSA participants will be treated with a CPAP/APAP treatment, per standard clinical care. Receives: Device: CPAP | |
| Control | Control participants will not receive APAP/CPAP treatment, if not diagnosed with OSA. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Magnitude of change in biomarkers during sleep in persons with OSA before & after successful treatment with CPAP, & differences in magnitude of change in persons with different degrees of visceral adiposity, & in those w/ & w/o specific comorbidities.
Measured: End of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2009 (estimated)
- Study startApr 2008
- Primary completion1 Feb 2015
- Study completion1 Feb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Obstructive Sleep Apnea (OSA)Studies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 181 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Allan Pack, University of Pennsylvania
- Investigators
- Allan I Pack, MD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00834509
- Sponsor's protocol ID
- 807416
- Other IDs
- P01HL094307
- Acronym
- BOSA
- Status last verified
- Apr 2017
- First submitted
- 2 Feb 2009
- Last updated
- 18 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Lim DC, Brady DC, Po P, Chuang LP, Marcondes L, Kim EY, Keenan BT, Guo X, Maislin G, Galante RJ, Pack AI. Simulating obstructive sleep apnea patients' oxygenation characteristics into a mouse model of cyclical intermittent hypoxia. J Appl Physiol (1985). 2015 Mar 1;118(5):544-57. doi: 10.1152/japplphysiol.00629.2014. Epub 2014 Nov 26.
PubMed 25429097
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Towards a Blood Test for Diagnosis of Obstructive Sleep Apnea
- ClinicalTrials.gov ID
- NCT00834509
- Acronym / sponsor ID
- BOSA / 807416
- Conditions
- Obstructive Sleep Apnea (OSA)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 181 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Apr 2008
- Primary completion
- 1 Feb 2015 (actual)
- Study completion
- 1 Feb 2015 (actual)
- First posted
- 3 Feb 2009 (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 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
Detailed description
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 Continuous Positive Airway Pressure (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 tumor necrosis factor alpha (TNFα) (inflammation); plasma norepinephrine (sympathetic activation); and free fatty acids. Secondary biomarkers will be: Interleukin 6 (IL-6), urinary norepinephrine; urinary normetanephrine; glucose, Intercellular Adhesion Molecule (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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Obstructive Sleep Apnea (OSA) | – | Device: CPAPOSA participants will be treated with a CPAP/APAP treatment, per standard clinical care. |
| Control | – | –Control participants will not receive APAP/CPAP treatment, if not diagnosed with OSA. |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- OSA patients with moderate to severe disease as confirmed by apnea-hypopnea index (AHI > 15) in a polysomnography. Healthy controls, both snorers and nonsnorers, with an apnea-hypopnea index (AHI < 5) in a polysomnography.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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
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 |
|---|---|---|
| CPAPUse CPAP for 4-6 weeks as clinically prescribed. | Device | Obstructive Sleep Apnea (OSA) |
Primary outcome
Magnitude of change in biomarkers during sleep in persons with OSA before & after successful treatment with CPAP, & differences in magnitude of change in persons with different degrees of visceral adiposity, & in those w/ & w/o specific comorbidities.
Time frame: End of study
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 18 Apr 2017.
- Derived from this study: PubMed 25429097Lim DC, Brady DC, Po P, Chuang LP, Marcondes L, Kim EY, Keenan BT, Guo X, Maislin G, Galante RJ, Pack AI. Simulating obstructive sleep apnea patients' oxygenation characteristics into a mouse model of cyclical intermittent hypoxia. J Appl Physiol (1985). 2015 Mar 1;118(5):544-57. doi: 10.1152/japplphysiol.00629.2014. Epub 2014 Nov 26.
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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.
Allan I Pack, MD principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obstructive Sleep Apnea (OSA), run by University of Pennsylvania at 1 site in United States.
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 5 inclusion and 9 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 18 Apr 2017. 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 United States. 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?
Magnitude of change in biomarkers during sleep in persons with OSA before & after successful treatment with CPAP, & differences in magnitude of change in persons with different degrees of visceral adiposity, & in those w/ & w/o specific comorbidities. (time frame: End of study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00834509, which also lists 1 linked publication.
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 18 Apr 2017.