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Circadian Variations of Prostaglandin in Sleep Apnea
This study has been completed.
Sponsor:
Kyoto University
Information provided by (Responsible Party):
Yuichi Chihara, Kyoto University
ClinicalTrials.gov Identifier:
NCT01096433
First received: March 29, 2010
Last updated: January 24, 2012
Last verified: January 2012
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Purpose
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 | Intervention |
|---|---|
| Sleep Apnea Continuous Positive Airway Pressure Prostaglandins Circadian Variations | Device: CPAP treatment |
| Study Type: | Interventional |
| Study Design: | 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 |
Resource links provided by NLM:
Further study details as provided by Yuichi Chihara, Kyoto University:
Primary Outcome Measures:
- Prostaglandins in the urine and blood [ Time Frame: baseline, and 2days, 3 months after CPAP ]
Secondary Outcome Measures:
- polysomnography measurements [ Time Frame: baseline, and 2days, 3 months after CPAP ]
- sleepiness and health-related quality of life [ Time Frame: 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 ]
- serum and urinary biomarker (inflammation, oxidative stress etc.) [ Time Frame: baseline, and 2days, 3 months after CPAP ]
- endothelial function [ Time Frame: baseline, and 2days, 3 months after CPAP ]
| Enrollment: | 64 |
| Study Start Date: | May 2010 |
| Study Completion Date: | January 2012 |
| Primary Completion Date: | October 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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)
|
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.
Eligibility| Ages Eligible for Study: | 20 Years and older (Adult, Senior) |
| 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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01096433
Please refer to this study by its ClinicalTrials.gov identifier: NCT01096433
Locations
| Japan | |
| Kyoto University Graduate School of Medicine | |
| Kyoto, Japan | |
Sponsors and Collaborators
Kyoto University
Investigators
| Principal Investigator: | Kazuo Chin, MD,PhD | Kyoto University, Graduate School of Medicine |
| Principal Investigator: | Yuichi Chihara, MD | Kyoto University |
More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Yuichi Chihara, Medical doctor, Kyoto University |
| ClinicalTrials.gov Identifier: | NCT01096433 History of Changes |
| Other Study ID Numbers: |
C-411 |
| Study First Received: | March 29, 2010 |
| Last Updated: | January 24, 2012 |
Keywords provided by Yuichi Chihara, Kyoto University:
|
Sleep apnea CPAP Prostaglandins Circadian variations |
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 |
ClinicalTrials.gov processed this record on September 18, 2017