The Roles of Prostanoids in Patients With Sleep Apnea Syndrome

March 25, 2013 updated by: Toru Oga, Kyoto University, Graduate School of Medicine

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

46

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Kyoto, Japan, 6068507
        • Kyoto University, Graduate School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CPAP
the subjects introduced with CPAP treatment
Device: CPAP treatment
CPAP treatment is to improve airway obstruct for obstructive sleep apnea, and after 3 months' treatment, we evaluate the effects.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
metabolites of arachidonic acid in the urine and blood
Time Frame: 3 months
3 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kyoto University, Graduate School of Medicine

Investigators

  • Principal Investigator: Kazuo Chin, MD, PhD, Kyoto Universuty, Graduate School of Medicine
  • Principal Investigator: Toru Oga, MD, PhD, Kyoto University, Graduate School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2009

Primary Completion (Actual)

March 1, 2013

Study Completion (Actual)

March 1, 2013

Study Registration Dates

First Submitted

November 17, 2009

First Submitted That Met QC Criteria

November 17, 2009

First Posted (Estimate)

November 18, 2009

Study Record Updates

Last Update Posted (Estimate)

March 27, 2013

Last Update Submitted That Met QC Criteria

March 25, 2013

Last Verified

March 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C368-kyoto

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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