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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01096433
Other study ID # C-411
Secondary ID
Status Completed
Phase N/A
First received March 29, 2010
Last updated January 24, 2012
Start date May 2010
Est. completion date January 2012

Study information

Verified date January 2012
Source Kyoto University
Contact n/a
Is FDA regulated No
Health authority Japan: Institutional Review Board
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 64
Est. completion date January 2012
Est. primary completion date October 2011
Accepts healthy volunteers No
Gender Both
Age group 20 Years and older
Eligibility 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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Device:
CPAP treatment
maintains upper airway patency and minimizes the obstructive events

Locations

Country Name City State
Japan Kyoto University Graduate School of Medicine Kyoto

Sponsors (1)

Lead Sponsor Collaborator
Kyoto University

Country where clinical trial is conducted

Japan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Prostaglandins in the urine and blood baseline, and 2days, 3 months after CPAP No
Secondary polysomnography measurements baseline, and 2days, 3 months after CPAP No
Secondary sleepiness and health-related quality of life baseline, and 2days, 3 months after CPAP No
Secondary Clinical measurements (blood pressure, heart rate, sympathetic activity etc) baseline, and 2days, 3 months after CPAP No
Secondary serum and urinary biomarker (inflammation, oxidative stress etc.) baseline, and 2days, 3 months after CPAP No
Secondary endothelial function baseline, and 2days, 3 months after CPAP No
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