Mechanism of Endothelial Dysfunction in Obstructive Sleep Apnea (OSA)

NCT01027078 | Terminated DMC

• 1 other identifier: 2009H0212
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Obstructive Sleep Apnea

Outcome Measures

Primary Outcomes (1)

• eNOS Expression

  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.

  Measured at basline and 3-months post-treatment (CPAP) initiation

Secondary Outcomes (1)

• Peroxynitrite Formation

  Measured at basline and 3-months post-treatment (CPAP) initiation

Other Outcomes (3)

• Superoxide Production

  Measured at basline and 3-months post-treatment (CPAP) initiation

• Plasma BH2 and BH4 Levels

  Measured at basline and 3-months post-treatment (CPAP) initiation

• Plasma ADMA Levels

  Measured at basline and 3-months post-treatment (CPAP) initiation

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• Hypertension defined by existing treatment with antihypertensives or any measurement of systolic pressure above 130 mmHg, or diastolic pressure above 85 mmHg;
• Dyslipidemia defined by fasting cholesterol above 200; or fasting LDL over 150 mg/dl;
• Diabetes defined as existing diagnosis, hemoglobin A1C \>7 or fasting glucose \>110 on two separate measurements (standard fasting glucose or HbA1C criteria);
• CAD defined by history of angina, coronary event or abnormal stress test;
• Peripheral Vascular Disease (PVD) defined by history of stroke, claudication or abnormal Ankle brachial index;
• Concurrent smoking;
• Pregnancy;
• 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.

Sponsors & Collaborators

• Ohio State University: lead

Study Sites (1)

The Davis Heart and Lung Research Institute

Columbus, Ohio, 43210, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

skin biopsies

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Rami Khayat, MD

  Ohio State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2009
• First Posted: December 7, 2009
• Study Start: November 1, 2009
• Primary Completion: February 4, 2022
• Study Completion: February 4, 2022
• Last Updated: June 28, 2022

Record last verified: 2022-06

Locations

US (1)