The Roles of Prostanoids in Patients With Sleep Apnea Syndrome
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| First Received Date ICMJE | November 17, 2009 | ||||||||
| Last Updated Date | March 25, 2013 | ||||||||
| Start Date ICMJE | December 2009 | ||||||||
| Primary Completion Date | March 2013 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
metabolites of arachidonic acid in the urine and blood [ Time Frame: 3 months ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01015872 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
polysomnography measurements, sleepiness and health-related quality of life, blood pressure and pulse rate, endothelial dysfunction, platelet aggregation, cardiac echo cardiography [ Time Frame: 3 months ] [ Designated as safety issue: No ] | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | The Roles of Prostanoids in Patients With Sleep Apnea Syndrome | ||||||||
| Official Title ICMJE | The Investigation of the Roles of Prostanoids in Patients With Sleep Apnea Syndrome | ||||||||
| 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. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Not Provided | ||||||||
| Study Design ICMJE | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Sleep Apnea | ||||||||
| Intervention ICMJE | Device: CPAP treatment
CPAP treatment is to improve airway obstruct for obstructive sleep apnea, and after 3 months' treatment, we evaluate the effects. |
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| Study Arm (s) | Experimental: CPAP
the subjects introduced with CPAP treatment
Intervention: Device: CPAP treatment |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Completed | ||||||||
| Enrollment ICMJE | 46 | ||||||||
| Completion Date | March 2013 | ||||||||
| Primary Completion Date | March 2013 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 20 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | Japan | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01015872 | ||||||||
| Other Study ID Numbers ICMJE | C368-kyoto | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Toru Oga, Kyoto University, Graduate School of Medicine | ||||||||
| Study Sponsor ICMJE | Kyoto University, Graduate School of Medicine | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | Kyoto University, Graduate School of Medicine | ||||||||
| Verification Date | March 2013 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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