The Roles of Prostanoids in Patients With Sleep Apnea Syndrome

Not Applicable

Completed

• Conditions: Sleep Apnea
• Interventions: Device: CPAP treatment

• Registration Number: NCT01015872
• Lead Sponsor: Kyoto University, Graduate School of Medicine

Brief Summary

The purpose of this study is to evaluate the relationships between prostanoids and various outcomes such as sleep disturbance, hypertension and arteriosclerosis in patients with sleep apnea syndrome(SAS). In the patients introduced to continuous positive airway pressure(CPAP) treatment, the effects of CPAP are also evaluated.

Detailed Description

SAS is characterized by abnormality during sleep and hypoxemia from apnea and hypopnea, followed by systemic inflammation and organ dysfunction like cardiovascular diseases. Systemic inflammation causes the activation of arachidonic acid metabolism, producing prostaglandins (PGs) and leukotrienes (LTs). In addition, significant relationships between PGD2 and PGE2 and sleep, PGF2α and hypertension, PGI2 and thromboxane and platelet aggregation and so on are reported. Therefore, it is hypothesized that many prostanoids affect the pathophysiology of SAS. However, the relationships between prostanoids and clinical outcomes in patients with SAS are unknown. Although CPAP is the major treatment of SAS, the effects of CPAP on prostanoids are not known, either. Thus, the purpose of this study is to evaluate those relationships.

Study Timeline

• Study First Submitted: 2009-11-17
• Study First Submitted QC: 2009-11-17
• Study First Posted: 2009-11-18
• Study Start: 2009-12
• Status Verified: 2013-03
• Primary Completion: 2013-03
• Study Completion: 2013-03
• Last Update Submitted: 2013-03-25
• Last Update Posted: 2013-03-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

Inclusion Criteria

• Subjects hospitalized in Kyoto University Hospital for careful examination of SAS

Exclusion Criteria

• Subjects with severe respiratory diseases, severe heart diseases, severe vascular diseases, or severe diabetes mellitus.
• Subjects taking nonsteroidal anti-inflammatory drugs, steroids or immunosuppressants.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CPAP	CPAP treatment	the subjects introduced with CPAP treatment

Primary Outcome Measures

Name	Time	Method
metabolites of arachidonic acid in the urine and blood	3 months

Secondary Outcome Measures

Name	Time	Method
Polysomnography measurements	3 months
Sleepiness and health-related quality of life	3 months
Blood pressure and pulse rate	3 months
Endothelial dysfunction	3 months
Platelet aggregation	3 months
Cardiac and neck echo cardiography	3 months

Trial Locations

Locations (1)

Kyoto University, Graduate School of Medicine; 🇯🇵 Kyoto, Japan