Mechanism of Endothelial Dysfunction in Obstructive Sleep Apnea (OSA)

Obstructive Sleep Apnea Clinical Trial

Official title:

Mechanism of Endothelial Dysfunction in Obstructive Sleep Apnea

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01027078
• Other study ID #: 2009H0212
• Status: Terminated
• Start date: November 2009
• Est. completion date: February 4, 2022

Study information

• Verified date: June 2022
• Source: Ohio State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 90
• Est. completion date: February 4, 2022
• Est. primary completion date: February 4, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Locations

Country	Name	City	State
United States	The Davis Heart and Lung Research Institute	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Ohio State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Superoxide Production	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
Other	Plasma BH2 and BH4 Levels	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).	Measured at basline and 3-months post-treatment (CPAP) initiation
Other	Plasma ADMA Levels	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).	Measured at basline and 3-months post-treatment (CPAP) initiation
Primary	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	Peroxynitrite Formation	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