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Mechanism of Endothelial Dysfunction in Obstructive Sleep Apnea (OSA)

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ClinicalTrials.gov Identifier: NCT01027078
Recruitment Status : Active, not recruiting
First Posted : December 7, 2009
Last Update Posted : March 21, 2019
Sponsor:
Information provided by (Responsible Party):
Rami Khayat, Ohio State University

Tracking Information
First Submitted Date December 4, 2009
First Posted Date December 7, 2009
Last Update Posted Date March 21, 2019
Study Start Date November 2009
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 3, 2013)
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.
Original Primary Outcome Measures Not Provided
Change History Complete list of historical versions of study NCT01027078 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: July 3, 2013)
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.
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures
 (submitted: July 3, 2013)
  • 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).
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Mechanism of Endothelial Dysfunction in Obstructive Sleep Apnea (OSA)
Official Title Mechanism of Endothelial Dysfunction in Obstructive Sleep Apnea
Brief Summary 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.
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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
skin biopsies
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.

Condition Obstructive Sleep Apnea
Intervention Not Provided
Study 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Estimated Enrollment
 (submitted: December 4, 2009)
72
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2019
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01027078
Other Study ID Numbers 2009H0212
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Rami Khayat, Ohio State University
Study Sponsor Rami Khayat
Collaborators Not Provided
Investigators
Principal Investigator: Rami Khayat, MD Ohio State University
PRS Account Ohio State University
Verification Date March 2019