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

November 17, 2009
March 25, 2013
December 2009
March 2013   (final data collection date for primary outcome measure)
metabolites of arachidonic acid in the urine and blood [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01015872 on ClinicalTrials.gov Archive Site
  • 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 ]
polysomnography measurements, sleepiness and health-related quality of life, blood pressure and pulse rate, endothelial dysfunction, platelet aggregation, cardiac echo cardiography [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
The Roles of Prostanoids in Patients With Sleep Apnea Syndrome
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.

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.

Interventional
Not Provided
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Sleep Apnea
Device: CPAP treatment
CPAP treatment is to improve airway obstruct for obstructive sleep apnea, and after 3 months' treatment, we evaluate the effects.
Experimental: CPAP
the subjects introduced with CPAP treatment
Intervention: Device: CPAP treatment
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
46
March 2013
March 2013   (final data collection date for primary outcome measure)

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.
Both
20 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT01015872
C368-kyoto
No
Toru Oga, Kyoto University, Graduate School of Medicine
Kyoto University, Graduate School of Medicine
Not Provided
Principal Investigator: Kazuo Chin, MD, PhD Kyoto Universuty, Graduate School of Medicine
Principal Investigator: Toru Oga, MD, PhD Kyoto University, Graduate School of Medicine
Kyoto University, Graduate School of Medicine
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP