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Circadian Variations of Prostaglandin in Sleep Apnea

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ClinicalTrials.gov Identifier: NCT01096433
Recruitment Status : Completed
First Posted : March 31, 2010
Last Update Posted : January 26, 2012
Sponsor:
Information provided by (Responsible Party):
Yuichi Chihara, Kyoto University

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Sleep Apnea Continuous Positive Airway Pressure Prostaglandins Circadian Variations Device: CPAP treatment Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Association of Circadian Variations,Sleep Architecture, Hypertension, and Prostaglandin in Sleep Apnea
Study Start Date : May 2010
Actual Primary Completion Date : October 2011
Actual Study Completion Date : January 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

Arms and Interventions
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Arm Intervention/treatment
Experimental: CPAP
The subjects introduced with CPAP treatment
 Device: CPAP treatment
maintains upper airway patency and minimizes the obstructive events
Other Name: REMstar (Respironics), Auto Set(Resmed), Goodnight (Tyco Healthcare)


Outcome Measures
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Primary Outcome Measures :
  1. Prostaglandins in the urine and blood [ Time Frame: baseline, and 2days, 3 months after CPAP ]

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

Eligibility Criteria
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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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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): NCT01096433


Locations
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Japan
Kyoto University Graduate School of Medicine
Kyoto, Japan
Sponsors and Collaborators
Kyoto University
Investigators
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Principal Investigator: Kazuo Chin, MD,PhD Kyoto University, Graduate School of Medicine
Principal Investigator: Yuichi Chihara, MD Kyoto University
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Yuichi Chihara, Medical doctor, Kyoto University
ClinicalTrials.gov Identifier: NCT01096433    
Other Study ID Numbers: C-411
First Posted: March 31, 2010    Key Record Dates
Last Update Posted: January 26, 2012
Last Verified: January 2012
Keywords provided by Yuichi Chihara, Kyoto University:
Sleep apnea
CPAP
Prostaglandins
Circadian variations
Additional relevant MeSH terms:
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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