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The Roles of Prostanoids in Patients With Sleep Apnea Syndrome

Primary Purpose

Sleep Apnea

Status

Completed

Phase

Not Applicable

Locations

Japan

Study Type

Interventional

Intervention

CPAP treatment

About this trial

This is an interventional treatment trial for Sleep Apnea focused on measuring sleep apnea syndrome, CPAP, prostanoids

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Kyoto University, Graduate School of Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CPAP

Arm Description

the subjects introduced with CPAP treatment

Outcomes

Primary Outcome Measures

metabolites of arachidonic acid in the urine and blood

Secondary Outcome Measures

Polysomnography measurements

Sleepiness and health-related quality of life

Blood pressure and pulse rate

Endothelial dysfunction

Platelet aggregation

Cardiac and neck echo cardiography

Full Information

NCT ID

NCT01015872

First Posted

November 17, 2009

Last Updated

March 25, 2013

Sponsor

Kyoto University, Graduate School of Medicine

1. Study Identification

Unique Protocol Identification Number

NCT01015872

Brief Title

The Roles of Prostanoids in Patients With Sleep Apnea Syndrome

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2013

Overall Recruitment Status

Completed

Study Start Date

December 2009 (undefined)

Primary Completion Date

March 2013 (Actual)

Study Completion Date

March 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Kyoto University, Graduate School of Medicine

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Sleep Apnea

Keywords

sleep apnea syndrome, CPAP, prostanoids

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

46 (Actual)

8. Arms, Groups, and Interventions

Arm Title

CPAP

Arm Type

Experimental

Arm Description

the subjects introduced with CPAP treatment

Intervention Type

Device

Intervention Name(s)

CPAP treatment

Intervention Description

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

Primary Outcome Measure Information:

Title

metabolites of arachidonic acid in the urine and blood

Time Frame

3 months

Secondary Outcome Measure Information:

Title

Polysomnography measurements

Time Frame

3 months

Title

Sleepiness and health-related quality of life

Time Frame

3 months

Title

Blood pressure and pulse rate

Time Frame

3 months

Title

Endothelial dysfunction

Time Frame

3 months

Title

Platelet aggregation

Time Frame

3 months

Title

Cardiac and neck echo cardiography

Time Frame

3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kazuo Chin, MD, PhD

Organizational Affiliation

Kyoto Universuty, Graduate School of Medicine

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Toru Oga, MD, PhD

Organizational Affiliation

Kyoto University, Graduate School of Medicine

Official's Role

Principal Investigator

Facility Information:

Facility Name

Kyoto University, Graduate School of Medicine

City

Kyoto

ZIP/Postal Code

6068507

Country

Japan

12. IPD Sharing Statement

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The Roles of Prostanoids in Patients With Sleep Apnea Syndrome

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