Circadian Variations of Prostaglandin in Sleep Apnea

Study Description

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Arms and Interventions

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Contacts and Locations

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
First Posted:	March 31, 2010
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