Biomarkers for Obstructive Sleep Apnea (BOSA)

This study is currently recruiting participants.
Verified December 2013 by University of Pennsylvania
Sponsor:
Collaborators:
Information provided by (Responsible Party):
Allan Pack, University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT00834509
First received: February 2, 2009
Last updated: December 20, 2013
Last verified: December 2013
  Purpose

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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: April 2008
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: October 2014 (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
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.

  Eligibility

Ages Eligible for Study:   30 Years to 70 Years
Genders Eligible for Study:   Both
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.

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00834509

Contacts
Contact: Colleen Walsh, MS 215-662-3189 colleen.walsh@uphs.upenn.edu
Contact: Frances Pack, RN 215-614-1807 fran.pack@uphs.upenn.edu

Locations
United States, Pennsylvania
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Principal Investigator: Allan I Pack, MB, ChB, PhD         
Sponsors and Collaborators
University of Pennsylvania
Investigators
Principal Investigator: Allan I Pack, MD University of Pennsylvania
  More Information

No publications provided

Responsible Party: Allan Pack, Principal Investigator, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT00834509     History of Changes
Other Study ID Numbers: 807416, P01HL094307
Study First Received: February 2, 2009
Last Updated: December 20, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on April 17, 2014