Circadian Variations of Prostaglandin in Sleep Apnea - Full Text View

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 Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Association of Circadian Variations,Sleep Architecture, Hypertension, and Prostaglandin in Sleep Apnea

Resource links provided by NLM:

MedlinePlus related topics: High Blood Pressure Sleep Apnea

U.S. FDA Resources

Further study details as provided by Kyoto University:

Primary Outcome Measures:

Prostaglandins in the urine and blood [ Time Frame: baseline, and 2days, 3 months after CPAP ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

polysomnography measurements [ Time Frame: baseline, and 2days, 3 months after CPAP ] [ Designated as safety issue: No ]
sleepiness and health-related quality of life [ Time Frame: baseline, and 2days, 3 months after CPAP ] [ Designated as safety issue: No ]
Clinical measurements (blood pressure, heart rate, sympathetic activity etc) [ Time Frame: baseline, and 2days, 3 months after CPAP ] [ Designated as safety issue: No ]
serum and urinary biomarker (inflammation, oxidative stress etc.) [ Time Frame: baseline, and 2days, 3 months after CPAP ] [ Designated as safety issue: No ]
endothelial function [ Time Frame: baseline, and 2days, 3 months after CPAP ] [ Designated as safety issue: No ]


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
Genders Eligible for Study:	Both
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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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

No publications provided by Kyoto University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Chihara Y, Chin K, Aritake K, Harada Y, Toyama Y, Murase K, Yoshimura C, Hitomi T, Oga T, Mishima M, Urade Y. A urine biomarker for severe obstructive sleep apnoea patients: lipocalin-type prostaglandin D synthase. Eur Respir J. 2013 Dec;42(6):1563-74. doi: 10.1183/09031936.00133512. Epub 2012 Dec 6.


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
Health Authority:	Japan: Institutional Review Board

Keywords provided by Kyoto University:


Sleep apnea CPAP Prostaglandins Circadian variations

Additional relevant MeSH terms:


Apnea Sleep Apnea Syndromes Dyssomnias Nervous System Diseases Respiration Disorders	Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory Sleep Disorders Sleep Disorders, Intrinsic

ClinicalTrials.gov processed this record on February 27, 2015