Circadian Variations of Prostaglandin in Sleep Apnea

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the associations of circadian variations, sleep architecture, hypertension and prostanoids in the patients with sleep apnea. In addition, the patients introduced to continuous positive airway pressure(CPAP) treatment, the effects of CPAP are also evaluated.

Detailed Description
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Obstructive sleep apnea (OSA) is characterized by repetitive episodes of upper airway obstruction during sleep that provoke frequents arousals, sleep fragmentation, oxygen desaturation, and excessive daytime sleepiness. OSA may contribute to the development of systemic hypertension, cardiovascular disease. Many studies has reported a crucial role for the prostaglandin D system in sleep regulation. In addition, it has been described urinary or blood levels of prostaglandins was higher in the patients with hypertension, diabetes mellitus, and these values were associated with the severity of coronary artery disease. However, the relation between alterations of prostaglandin D system and sleep architecture, sleepiness, and clinical outcomes such as hypertension, arteriosclerosis in the patients with OSA are not known. Additionally, after CPAP treatment, we will investigate the association between change of prostaglandin system and sleep architecture, sleepiness, clinical outcomes.

Official Title
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Association of Circadian Variations,Sleep Architecture, Hypertension, and Prostaglandin in Sleep Apnea

Conditions
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Sleep Apnea, Continuous Positive Airway Pressure, Prostaglandins, Circadian Variations

Intervention / Treatment
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* Device: CPAP treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects on admission for sleep study under the Respiratory Care and Sleep Control Medicine, Kyoto University Hospital. Subjects diagnosed with OSA (apnea hypopnea index >=5/hour) by overnight polysomnography. Exclusion Criteria: Subjects treating for acute infections or malignancy. Subjects with severe cardiovascular disease, diabetes,and renal failure. Subjects taking nonsteroidal anti-inflammatory drugs, steroids or immunosuppressants.

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CPAP<br>The subjects introduced with CPAP treatment | Device: CPAP treatment<br>* maintains upper airway patency and minimizes the obstructive events<br>* Other names: REMstar (Respironics), Auto Set(Resmed), Goodnight (Tyco Healthcare);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prostaglandins in the urine and blood |  | baseline, and 2days, 3 months after CPAP | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| polysomnography measurements |  | baseline, and 2days, 3 months after CPAP | 
| sleepiness and health-related quality of life |  | baseline, and 2days, 3 months after CPAP | 
| Clinical measurements (blood pressure, heart rate, sympathetic activity etc) |  | baseline, and 2days, 3 months after CPAP | 
| serum and urinary biomarker (inflammation, oxidative stress etc.) |  | baseline, and 2days, 3 months after CPAP | 
| endothelial function |  | baseline, and 2days, 3 months after CPAP | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sleep apnea, CPAP, Prostaglandins, Circadian variations