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

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)
|
- Prostaglandins in the urine and blood [ Time Frame: baseline, and 2days, 3 months after CPAP ]
- 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 ]

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Ages Eligible for Study: | 20 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

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
Japan | |
Kyoto University Graduate School of Medicine | |
Kyoto, Japan |
Principal Investigator: | Kazuo Chin, MD,PhD | Kyoto University, Graduate School of Medicine | |
Principal Investigator: | Yuichi Chihara, MD | Kyoto University |
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 |
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:
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 |