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The Roles of Prostanoids in Patients With Sleep Apnea Syndrome

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ClinicalTrials.gov Identifier: NCT01015872
Recruitment Status : Completed
First Posted : November 18, 2009
Last Update Posted : March 27, 2013
Sponsor:
Information provided by (Responsible Party):
Toru Oga, Kyoto University, Graduate School of Medicine

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.

Condition or disease Intervention/treatment Phase
Sleep Apnea Device: CPAP treatment Not Applicable

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  (Clinical Trial)
Actual Enrollment : 46 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Investigation of the Roles of Prostanoids in Patients With Sleep Apnea Syndrome
Study Start Date : December 2009
Actual Primary Completion Date : March 2013
Actual Study Completion Date : March 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea
U.S. FDA Resources

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.



Primary Outcome Measures :
  1. metabolites of arachidonic acid in the urine and blood [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. Polysomnography measurements [ Time Frame: 3 months ]
  2. Sleepiness and health-related quality of life [ Time Frame: 3 months ]
  3. Blood pressure and pulse rate [ Time Frame: 3 months ]
  4. Endothelial dysfunction [ Time Frame: 3 months ]
  5. Platelet aggregation [ Time Frame: 3 months ]
  6. Cardiac and neck echo cardiography [ Time Frame: 3 months ]


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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: November 18, 2009    Key Record Dates
Last Update Posted: March 27, 2013
Last Verified: March 2013

Keywords provided by Toru Oga, 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 Wake Disorders
Nervous System Diseases