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Completed

NCT Number: NCT01096433

Circadian Variations of Prostaglandin in Sleep Apnea

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.

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Key information

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kyoto University Graduate School of Medicine

Kyoto, Japan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CPAP Treatment

Device

maintains upper airway patency and minimizes the obstructive events

Other names: REMstar (Respironics), Auto Set(Resmed), Goodnight (Tyco Healthcare)

Primary outcomes

  1. Prostaglandins in the urine and blood

    Time frame: baseline, and 2days, 3 months after CPAP

Secondary outcomes

  1. polysomnography measurements

    Time frame: baseline, and 2days, 3 months after CPAP

  2. sleepiness and health-related quality of life

    Time frame: baseline, and 2days, 3 months after CPAP

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

    Time frame: baseline, and 2days, 3 months after CPAP

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

    Time frame: baseline, and 2days, 3 months after CPAP

  5. endothelial function

    Time frame: baseline, and 2days, 3 months after CPAP

Sponsors and collaborators

Lead sponsor

Kyoto University

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2011
Study completion
2012
First posted
Mar 31, 2010
Registry last updated
Jan 26, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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