The Roles of Prostanoids in Patients With Sleep Apnea Syndrome

Sleep Apnea Clinical Trial

Official title:

The Investigation of the Roles of Prostanoids in Patients With Sleep Apnea Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01015872
• Other study ID #: C368-kyoto
• Status: Completed
• Phase: N/A
• First received: November 17, 2009
• Last updated: March 25, 2013
• Start date: December 2009
• Est. completion date: March 2013

Study information

• Verified date: March 2013
• Source: Kyoto University, Graduate School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Apnea
• Sleep Apnea
• Sleep Apnea Syndromes

Intervention

Device:
• CPAP treatment
CPAP treatment is to improve airway obstruct for obstructive sleep apnea, and after 3 months' treatment, we evaluate the effects.

Locations

Country	Name	City	State
Japan	Kyoto University, Graduate School of Medicine	Kyoto

Sponsors (1)

Lead Sponsor	Collaborator
Kyoto University, Graduate School of Medicine

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	metabolites of arachidonic acid in the urine and blood		3 months	No
Secondary	Polysomnography measurements		3 months	No
Secondary	Sleepiness and health-related quality of life		3 months	No
Secondary	Blood pressure and pulse rate		3 months	No
Secondary	Endothelial dysfunction		3 months	No
Secondary	Platelet aggregation		3 months	No
Secondary	Cardiac and neck echo cardiography		3 months	No