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Circadian Variations of Prostaglandin in Sleep Apnea

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Yuichi Chihara, Kyoto University
ClinicalTrials.gov Identifier:
NCT01096433
First received: March 29, 2010
Last updated: January 24, 2012
Last verified: January 2012
History of Changes
  Purpose

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 Intervention
Sleep Apnea
Continuous Positive Airway Pressure
Prostaglandins
Circadian Variations
 Device: CPAP treatment

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Association of Circadian Variations,Sleep Architecture, Hypertension, and Prostaglandin in Sleep Apnea

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Kyoto University:

Primary Outcome Measures:
  • Prostaglandins in the urine and blood [ Time Frame: baseline, and 2days, 3 months after CPAP ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • polysomnography measurements [ Time Frame: baseline, and 2days, 3 months after CPAP ] [ Designated as safety issue: No ]
  • sleepiness and health-related quality of life [ Time Frame: baseline, and 2days, 3 months after CPAP ] [ Designated as safety issue: No ]
  • Clinical measurements (blood pressure, heart rate, sympathetic activity etc) [ Time Frame: baseline, and 2days, 3 months after CPAP ] [ Designated as safety issue: No ]
  • serum and urinary biomarker (inflammation, oxidative stress etc.) [ Time Frame: baseline, and 2days, 3 months after CPAP ] [ Designated as safety issue: No ]
  • endothelial function [ Time Frame: baseline, and 2days, 3 months after CPAP ] [ Designated as safety issue: No ]

Enrollment: 64
Study Start Date: May 2010
Study Completion Date: January 2012
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

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

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01096433

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

No publications provided

Responsible Party: Yuichi Chihara, Medical doctor, Kyoto University
ClinicalTrials.gov Identifier: NCT01096433     History of Changes
Other Study ID Numbers: C-411
Study First Received: March 29, 2010
Last Updated: January 24, 2012
Health Authority: Japan: Institutional Review Board

Keywords provided by 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 Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on May 23, 2013