NCT01015872

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 17, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 18, 2009

Completed
13 days until next milestone

Study Start

First participant enrolled

December 1, 2009

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
Last Updated

March 27, 2013

Status Verified

March 1, 2013

Enrollment Period

3.2 years

First QC Date

November 17, 2009

Last Update Submit

March 25, 2013

Conditions

Sleep Apnea

Keywords

sleep apnea syndromeCPAPprostanoids

Outcome Measures

Primary Outcomes (1)

  • metabolites of arachidonic acid in the urine and blood

    3 months

Secondary Outcomes (6)

  • Polysomnography measurements

    3 months

  • Sleepiness and health-related quality of life

    3 months

  • Blood pressure and pulse rate

    3 months

  • Endothelial dysfunction

    3 months

  • Platelet aggregation

    3 months

  • +1 more secondary outcomes

Study Arms (1)

CPAP

EXPERIMENTAL

the subjects introduced with CPAP treatment

Device: CPAP treatment

Interventions

CPAP treatmentDEVICE

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

CPAP

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kyoto University, Graduate School of Medicine

Kyoto, Kyoto, 6068507, Japan

Location

MeSH Terms

Conditions

Sleep Apnea Syndromes

Interventions

Continuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

ApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Intervention Hierarchy (Ancestors)

Positive-Pressure RespirationRespiration, ArtificialAirway ManagementTherapeuticsRespiratory Therapy

Study Officials

  • Kazuo Chin, MD, PhD

    Kyoto Universuty, Graduate School of Medicine

    PRINCIPAL INVESTIGATOR

  • Toru Oga, MD, PhD

    Kyoto University, Graduate School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Respiratory Care and Sleep Control Medicine, Kyoto University, Graduate School of Medicine

Study Record Dates

First Submitted

November 17, 2009

First Posted

November 18, 2009

Study Start

December 1, 2009

Primary Completion

March 1, 2013

Study Completion

March 1, 2013

Last Updated

March 27, 2013

Record last verified: 2013-03

Locations

JP(1)