Circadian Variations of Prostaglandin in Sleep Apnea

Sleep Apnea Clinical Trial

Official title:

Association of Circadian Variations,Sleep Architecture, Hypertension, and Prostaglandin in Sleep Apnea

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01096433
• Other study ID #: C-411
• 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

• Apnea
• Circadian Variations
• Continuous Positive Airway Pressure
• Prostaglandins
• Sleep Apnea
• Sleep Apnea Syndromes

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