Clinical trial NCT01096433: Circadian Variations of Prostaglandin in Sleep Apnea
Official title: Association of Circadian Variations,Sleep Architecture, Hypertension, and Prostaglandin in Sleep Apnea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Apnea
Continuous Positive Airway Pressure
Prostaglandins
Circadian Variations
Keywords: Sleep apnea
CPAP
Prostaglandins
Circadian variations
Lead sponsor: Kyoto University Hospital
Sponsor class: OTHER
First posted: 2010-03-31
Enrollment: 64
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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 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.

Primary outcomes:
measure: Prostaglandins in the urine and blood
timeFrame: baseline, and 2days, 3 months after CPAP
Secondary outcomes:
measure: polysomnography measurements
timeFrame: baseline, and 2days, 3 months after CPAP
measure: sleepiness and health-related quality of life
timeFrame: baseline, and 2days, 3 months after CPAP
measure: Clinical measurements (blood pressure, heart rate, sympathetic activity etc)
timeFrame: baseline, and 2days, 3 months after CPAP
measure: serum and urinary biomarker (inflammation, oxidative stress etc.)
timeFrame: baseline, and 2days, 3 months after CPAP
measure: endothelial function
timeFrame: baseline, and 2days, 3 months after CPAP
Other outcomes:
Locations:
city: Kyoto
country: Japan
facility: Kyoto University Graduate School of Medicine
Study officials:
affiliation: Kyoto University, Graduate School of Medicine
name: Kazuo Chin, MD,PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Kyoto University Hospital
name: Yuichi Chihara, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.