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Oxidative Stress in Obstructive Sleep Apnea: Correlation of Biomarkers and Nasal CPAP Compliance

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01661699
First Posted: August 9, 2012
Last Update Posted: August 28, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Christina Reichner, M.D., Georgetown University
  Purpose
The purpose of this study is to check blood and urine levels to further define markers/tests in the blood and urine that would be useful in following patients with obstructive sleep apnea and then to see if by wearing CPAP every night, these markers can be reduced. This research is being done because currently there are no effective blood or urine markers to determine how well CPAP is working.

Condition
Sleep Apnea, Obstructive

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Oxidative Stress in Obstructive Sleep Apnea: Correlation of Biomarkers and Nasal CPAP Compliance

Resource links provided by NLM:


Further study details as provided by Christina Reichner, M.D., Georgetown University:

Primary Outcome Measures:
  • Determining biomarkers for polysomnography characteristics before and after CPAP treatment [ Time Frame: 6 months ]
    The primary objective of this pilot study will determine the biomarkers for polysomnography characteristics with CPAP treatment from baseline to 6 months in patients with obstructive sleep apnea. The results will guide biomarker selection for full scale studies.


Enrollment: 24
Study Start Date: August 2011
Study Completion Date: July 2014
Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Sleep apnea
Those suspected of sleep apnea and scheduled for polysomnography and treated with CPAP therapy.

Detailed Description:
The goal of this study is to further define biomarkers that would be useful in following patients with obstructive sleep apnea and examining their response to compliance to therapy with CPAP. To date no correlation between biomarkers of oxidative stress and compliance to CPAP has been measured. CPAP is the most effective treatment for obstructive sleep apnea and has been show to reduce blood pressure and decrease oxidative stress.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Those over 18 years suspected of having sleep apnea.
Criteria

Inclusion Criteria:

  • Men and Women over 18 years suspected of having sleep apnea

Exclusion Criteria:

  • Those under 18 years or not suspected of having sleep apnea
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01661699


Locations
United States, District of Columbia
Georgetown University Hospital
Washington, District of Columbia, United States, 20007
Sponsors and Collaborators
Georgetown University
Investigators
Principal Investigator: Cristina Reichner, MD Georgetown University
  More Information

Responsible Party: Christina Reichner, M.D., M.D., Associate Professor Medicine, Georgetown University
ClinicalTrials.gov Identifier: NCT01661699     History of Changes
Other Study ID Numbers: 2011-416
First Submitted: August 3, 2012
First Posted: August 9, 2012
Last Update Posted: August 28, 2014
Last Verified: August 2014

Keywords provided by Christina Reichner, M.D., Georgetown University:
Obstructive Sleep Apnea

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