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Completed

NCT Number: NCT01015872

The Roles of Prostanoids in Patients With Sleep Apnea Syndrome

The purpose of this study is to evaluate the relationships between prostanoids and various outcomes such as sleep disturbance, hypertension and arteriosclerosis in patients with sleep apnea syndrome(SAS). In the patients introduced to continuous positive airway pressure(CPAP) treatment, the effects of CPAP are also evaluated.

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Key information

Conditions

Sleep Apnea Apnea Dyssomnias Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Disorders, Intrinsic Sleep Wake Disorders

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, 6068507, Japan

About this study

SAS is characterized by abnormality during sleep and hypoxemia from apnea and hypopnea, followed by systemic inflammation and organ dysfunction like cardiovascular diseases. Systemic inflammation causes the activation of arachidonic acid metabolism, producing prostaglandins (PGs) and leukotrienes (LTs). In addition, significant relationships between PGD2 and PGE2 and sleep, PGF2α and hypertension, PGI2 and thromboxane and platelet aggregation and so on are reported. Therefore, it is hypothesized that many prostanoids affect the pathophysiology of SAS. However, the relationships between prostanoids and clinical outcomes in patients with SAS are unknown. Although CPAP is the major treatment of SAS, the effects of CPAP on prostanoids are not known, either. Thus, the purpose of this study is to evaluate those relationships.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Subjects hospitalized in Kyoto University Hospital for careful examination of SAS

Exclusion criteria

  • Subjects with severe respiratory diseases, severe heart diseases, severe vascular diseases, or severe diabetes mellitus.
  • Subjects taking nonsteroidal anti-inflammatory drugs, steroids or immunosuppressants.

Treatment and study plan

CPAP Treatment

Device

CPAP treatment is to improve airway obstruct for obstructive sleep apnea, and after 3 months' treatment, we evaluate the effects.

Primary outcomes

  1. metabolites of arachidonic acid in the urine and blood

    Time frame: 3 months

Secondary outcomes

  1. Polysomnography measurements

    Time frame: 3 months

  2. Sleepiness and health-related quality of life

    Time frame: 3 months

  3. Blood pressure and pulse rate

    Time frame: 3 months

  4. Endothelial dysfunction

    Time frame: 3 months

  5. Platelet aggregation

    Time frame: 3 months

  6. Cardiac and neck echo cardiography

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

Kyoto University, Graduate School of Medicine

Other

Registry information

Official study title

The Investigation of the Roles of Prostanoids in Patients With Sleep Apnea Syndrome

Important dates

Study start
2009
Primary completion
2013
Study completion
2013
First posted
Nov 18, 2009
Registry last updated
Mar 27, 2013

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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