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Biomarkers for Obstructive Sleep Apnea (BOSA)

This study is ongoing, but not recruiting participants.
National Institutes of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Allan Pack, University of Pennsylvania Identifier:
First received: February 2, 2009
Last updated: May 27, 2015
Last verified: May 2015

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

Condition Intervention
Obstructive Sleep Apnea (OSA)
Device: CPAP

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Towards a Blood Test for Diagnosis of Obstructive Sleep Apnea

Resource links provided by NLM:

Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 40
Study Start Date: April 2008
Estimated Study Completion Date: October 2016
Estimated Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Obstructive Sleep Apnea (OSA)
OSA participants will be treated with a CPAP/APAP treatment, per standard clinical care.
Device: CPAP
Use CPAP for 4-6 weeks as clinically prescribed.
Control participants will not receive APAP/CPAP treatment, if not diagnosed with OSA.

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.

Ages Eligible for Study:   30 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
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.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00834509

United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
National Institutes of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)
Principal Investigator: Allan I Pack, MD University of Pennsylvania
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Allan Pack, Principal Investigator, University of Pennsylvania Identifier: NCT00834509     History of Changes
Other Study ID Numbers: 807416
P01HL094307 ( US NIH Grant/Contract Award Number )
Study First Received: February 2, 2009
Last Updated: May 27, 2015

Additional relevant MeSH terms:
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases processed this record on March 27, 2017