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Circadian Variations of Prostaglandin in Sleep Apnea

Primary Purpose

Sleep Apnea, Continuous Positive Airway Pressure, Prostaglandins

Status

Completed

Phase

Not Applicable

Locations

Japan

Study Type

Interventional

Intervention

CPAP treatment

About this trial

This is an interventional treatment trial for Sleep Apnea focused on measuring Sleep apnea, CPAP, Prostaglandins, Circadian variations

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Kyoto University Graduate School of Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CPAP

Arm Description

The subjects introduced with CPAP treatment

Outcomes

Primary Outcome Measures

Prostaglandins in the urine and blood

Secondary Outcome Measures

polysomnography measurements

sleepiness and health-related quality of life

Clinical measurements (blood pressure, heart rate, sympathetic activity etc)

serum and urinary biomarker (inflammation, oxidative stress etc.)

endothelial function

Full Information

NCT ID

NCT01096433

First Posted

March 29, 2010

Last Updated

January 24, 2012

Sponsor

Kyoto University

1. Study Identification

Unique Protocol Identification Number

NCT01096433

Brief Title

Circadian Variations of Prostaglandin in Sleep Apnea

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2012

Overall Recruitment Status

Completed

Study Start Date

May 2010 (undefined)

Primary Completion Date

October 2011 (Actual)

Study Completion Date

January 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Kyoto University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Sleep Apnea, Continuous Positive Airway Pressure, Prostaglandins, Circadian Variations

Keywords

Sleep apnea, CPAP, Prostaglandins, Circadian variations

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

64 (Actual)

8. Arms, Groups, and Interventions

Arm Title

CPAP

Arm Type

Experimental

Arm Description

The subjects introduced with CPAP treatment

Intervention Type

Device

Intervention Name(s)

CPAP treatment

Other Intervention Name(s)

REMstar (Respironics), Auto Set(Resmed), Goodnight (Tyco Healthcare)

Intervention Description

maintains upper airway patency and minimizes the obstructive events

Primary Outcome Measure Information:

Title

Prostaglandins in the urine and blood

Time Frame