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The Roles of Prostanoids in Patients With Sleep Apnea Syndrome

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01015872
Enrollment
46
Registered
2009-11-18
Start date
2009-12-31
Completion date
2013-03-31
Last updated
2013-03-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sleep Apnea

Keywords

sleep apnea syndrome, CPAP, prostanoids

Brief summary

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.

Detailed description

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.

Interventions

DEVICECPAP treatment

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

Sponsors

Kyoto University, Graduate School of Medicine
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
metabolites of arachidonic acid in the urine and blood3 months

Secondary

MeasureTime frame
Sleepiness and health-related quality of life3 months
Blood pressure and pulse rate3 months
Polysomnography measurements3 months
Platelet aggregation3 months
Cardiac and neck echo cardiography3 months
Endothelial dysfunction3 months

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026