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Mechanism of Endothelial Dysfunction in Obstructive Sleep Apnea (OSA)

This study is currently recruiting participants.
Verified January 2017 by Rami Khayat, The Ohio State University
Sponsor:
ClinicalTrials.gov Identifier:
NCT01027078
First Posted: December 7, 2009
Last Update Posted: January 16, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Rami Khayat, The Ohio State University
  Purpose
The investigators hypothesized that patients with Obstructive Sleep Apnea (OSA) who are free of any cardiovascular disease will have early microcirculatory changes that are unique to OSA, and therefore would resolve with treatment of OSA.

Condition
Obstructive Sleep Apnea

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Mechanism of Endothelial Dysfunction in Obstructive Sleep Apnea

Resource links provided by NLM:


Further study details as provided by Rami Khayat, The Ohio State University:

Primary Outcome Measures:
  • eNOS Expression [ Time Frame: Measured at basline and 3-months post-treatment (CPAP) initiation ]
    All measurements will be obtained upon diagnosis of OSA and 12 weeks after effective treatment with continuous positive airway pressure (CPAP). Controls will receive all measurements at baseline.


Secondary Outcome Measures:
  • Peroxynitrite Formation [ Time Frame: Measured at basline and 3-months post-treatment (CPAP) initiation ]
    All measurements will be obtained upon diagnosis of OSA and 12 weeks after effective treatment with continuous positive airway pressure (CPAP). Controls will receive all measurements at baseline.


Other Outcome Measures:
  • Superoxide Production [ Time Frame: Measured at basline and 3-months post-treatment (CPAP) initiation ]
    All measurements will be obtained upon diagnosis of OSA and 12 weeks after effective treatment with continuous positive airway pressure (CPAP). Controls will receive all measurements at baseline.

  • Plasma BH2 and BH4 Levels [ Time Frame: Measured at basline and 3-months post-treatment (CPAP) initiation ]
    All measurements will be obtained upon diagnosis of OSA and 12 weeks after effective treatment with continuous positive airway pressure (CPAP). Controls will receive all measurements at baseline. The BH2/BH4 ratio will be measured using high pressure liquid chromatography (HPLC).

  • Plasma ADMA Levels [ Time Frame: Measured at basline and 3-months post-treatment (CPAP) initiation ]
    All measurements will be obtained upon diagnosis of OSA and 12 weeks after effective treatment with continuous positive airway pressure (CPAP). Controls will receive all measurements at baseline. Plasma ADMA levels will be measured using high pressure liquid chromatography (HPLC).


Biospecimen Retention:   Samples With DNA
skin biopsies

Estimated Enrollment: 72
Study Start Date: November 2009
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts
OSA
patients diagnosed with obstructive sleep apnea who do not have existing cardiovascular disease
control
patients without obstructive sleep apnea who are matched in weight and age to the OSA patients

Detailed Description:

Impaired vascular regulation of the microcirculation is a consequence of Obstructive Sleep Apnea (OSA). Nitric Oxide (NO) related endothelial dysfunction occurs in OSA as the earliest vascular abnormality prior to the manifestation of vascular disease and it results in impaired vasodilatory response to hypoxia. These abnormalities have already been described in OSA patients. The role of oxidative stress in endothelial dysfunction is present in vascular disorders. The presence of oxidative stress in OSA patients is also well established. The effect of increased superoxide on endothelial function has also been described in the literature. The mechanism of this effect is unknown and is the focus of this research.

We hypothesized that patients with Obstructive Sleep Apnea (OSA) who are free of any cardiovascular disease will have early microcirculatory changes that are unique to OSA, and therefore would resolve with treatment of OSA.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Participants: will be 36 patients with newly diagnosed OSA and 36 age and BMI matched controls.

Patients with OSA will be enrolled from the sleep disorders center at OSU among patients who underwent a recent (past 4 weeks) polysomnography that is positive for OSA, and never were treated with CPAP.

Inclusion criteria will be AHI > 15 events per hours.

Criteria

Inclusion criteria:

1. Apnea-Hypopnea Index (AHI) > 15 events per hours.

Exclusion criteria:

  1. Hypertension defined by existing treatment with antihypertensives or any measurement of systolic pressure above 130 mmHg, or diastolic pressure above 85 mmHg;
  2. Dyslipidemia defined by fasting cholesterol above 200; or fasting LDL over 150 mg/dl;
  3. Diabetes defined as existing diagnosis, hemoglobin A1C >7 or fasting glucose >110 on two separate measurements (standard fasting glucose or HbA1C criteria);
  4. CAD defined by history of angina, coronary event or abnormal stress test;
  5. Peripheral Vascular Disease (PVD) defined by history of stroke, claudication or abnormal Ankle brachial index;
  6. Concurrent smoking;
  7. Pregnancy;
  8. Use of erectile dysfunction drugs, or any medications for chronic conditions; 9)Chronic liver or renal disease. Fasting blood test for glucose, cholesterol, on all participants who have not had these tests in the 6 month prior to enrollment, will be obtained at the time of screening. The remaining criteria will be evaluated by reviewing the medical records and history taking on the day of first visit.
  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): NCT01027078


Contacts
Contact: Angela Sow angela.sow@osumc.edu

Locations
United States, Ohio
The Davis Heart and Lung Research Institute Recruiting
Columbus, Ohio, United States, 43210
Contact: Angela Sow    614-292-3962    angela.sow@osumc.edu   
Sponsors and Collaborators
Rami Khayat
Investigators
Principal Investigator: Rami Khayat, MD Ohio State University
  More Information

Responsible Party: Rami Khayat, Associate Professor, The Ohio State University
ClinicalTrials.gov Identifier: NCT01027078     History of Changes
Other Study ID Numbers: 2009H0212
First Submitted: December 4, 2009
First Posted: December 7, 2009
Last Update Posted: January 16, 2017
Last Verified: January 2017

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 Wake Disorders
Nervous System Diseases