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The Roles of Prostanoids in Patients With Sleep Apnea Syndrome

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Toru Oga, Kyoto University, Graduate School of Medicine
ClinicalTrials.gov Identifier:
NCT01015872
First received: November 17, 2009
Last updated: March 25, 2013
Last verified: March 2013
History of Changes
  Purpose

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.


Condition Intervention
Sleep Apnea
 Device: CPAP treatment

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Investigation of the Roles of Prostanoids in Patients With Sleep Apnea Syndrome

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Kyoto University, Graduate School of Medicine:

Primary Outcome Measures:
  • metabolites of arachidonic acid in the urine and blood [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Polysomnography measurements [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Sleepiness and health-related quality of life [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Blood pressure and pulse rate [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Endothelial dysfunction [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Platelet aggregation [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Cardiac and neck echo cardiography [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Enrollment: 46
Study Start Date: December 2009
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01015872

Locations
Japan
Kyoto University, Graduate School of Medicine
Kyoto, Japan, 6068507
Sponsors and Collaborators
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
  More Information

No publications provided

Responsible Party: Toru Oga, Respiratory Care and Sleep Control Medicine, Kyoto University, Graduate School of Medicine, Kyoto University, Graduate School of Medicine
ClinicalTrials.gov Identifier: NCT01015872     History of Changes
Other Study ID Numbers: C368-kyoto
Study First Received: November 17, 2009
Last Updated: March 25, 2013
Health Authority: Japan: Institutional Review Board

Keywords provided by Kyoto University, Graduate School of Medicine:
sleep apnea syndrome
CPAP
prostanoids

Additional relevant MeSH terms:
Apnea
Sleep Apnea Syndromes
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
 Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on May 22, 2013