Circadian Variations of Prostaglandin in Sleep Apnea

January 24, 2012 updated by: Yuichi Chihara, Kyoto University

Association of Circadian Variations,Sleep Architecture, Hypertension, and Prostaglandin in Sleep Apnea

The purpose of this study is to evaluate the associations of circadian variations, sleep architecture, hypertension and prostanoids in the patients with sleep apnea. In addition, 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

Obstructive sleep apnea (OSA) is characterized by repetitive episodes of upper airway obstruction during sleep that provoke frequents arousals, sleep fragmentation, oxygen desaturation, and excessive daytime sleepiness. OSA may contribute to the development of systemic hypertension, cardiovascular disease. Many studies has reported a crucial role for the prostaglandin D system in sleep regulation. In addition, it has been described urinary or blood levels of prostaglandins was higher in the patients with hypertension, diabetes mellitus, and these values were associated with the severity of coronary artery disease. However, the relation between alterations of prostaglandin D system and sleep architecture, sleepiness, and clinical outcomes such as hypertension, arteriosclerosis in the patients with OSA are not known. Additionally, after CPAP treatment, we will investigate the association between change of prostaglandin system and sleep architecture, sleepiness, clinical outcomes.

Study Type

Interventional

Enrollment (Actual)

64

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
        • 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 on admission for sleep study under the Respiratory Care and Sleep Control Medicine, Kyoto University Hospital.
  • Subjects diagnosed with OSA (apnea hypopnea index >=5/hour) by overnight polysomnography.

Exclusion Criteria:

  • Subjects treating for acute infections or malignancy.
  • Subjects with severe cardiovascular disease, diabetes,and renal failure.
  • 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: Non-Randomized
  • 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
maintains upper airway patency and minimizes the obstructive events
Other Names:
  • REMstar (Respironics), Auto Set(Resmed), Goodnight (Tyco Healthcare)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Prostaglandins in the urine and blood
Time Frame: baseline, and 2days, 3 months after CPAP
baseline, and 2days, 3 months after CPAP

Secondary Outcome Measures

Outcome Measure
Time Frame
polysomnography measurements
Time Frame: baseline, and 2days, 3 months after CPAP
baseline, and 2days, 3 months after CPAP
sleepiness and health-related quality of life
Time Frame: baseline, and 2days, 3 months after CPAP
baseline, and 2days, 3 months after CPAP
Clinical measurements (blood pressure, heart rate, sympathetic activity etc)
Time Frame: baseline, and 2days, 3 months after CPAP
baseline, and 2days, 3 months after CPAP
serum and urinary biomarker (inflammation, oxidative stress etc.)
Time Frame: baseline, and 2days, 3 months after CPAP
baseline, and 2days, 3 months after CPAP
endothelial function
Time Frame: baseline, and 2days, 3 months after CPAP
baseline, and 2days, 3 months after CPAP

Collaborators and Investigators

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

Sponsor

Kyoto University

Investigators

  • Principal Investigator: Kazuo Chin, MD,PhD, Kyoto University, Graduate School of Medicine
  • Principal Investigator: Yuichi Chihara, MD, Kyoto University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

May 1, 2010

Primary Completion (Actual)

October 1, 2011

Study Completion (Actual)

January 1, 2012

Study Registration Dates

First Submitted

March 29, 2010

First Submitted That Met QC Criteria

March 30, 2010

First Posted (Estimate)

March 31, 2010

Study Record Updates

Last Update Posted (Estimate)

January 26, 2012

Last Update Submitted That Met QC Criteria

January 24, 2012

Last Verified

January 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C-411

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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