NCT00780923

Brief Summary

The purpose of this study is to evaluate the effects of CPAP treatment on airway and systemic inflammation in obstructive sleep apnea.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
43

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2009

Typical duration 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 27, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 28, 2008

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2009

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
Last Updated

March 27, 2013

Status Verified

March 1, 2013

Enrollment Period

2.2 years

First QC Date

October 27, 2008

Last Update Submit

March 25, 2013

Conditions

Obstructive Sleep ApneaInflammationContinuous Positive Airway Pressure

Outcome Measures

Primary Outcomes (1)

  • Inflammatory biomarkers in induced sputum and blood. Cell counts in induced sputum.

    3 months

Secondary Outcomes (6)

  • NO in exhaled breath

    3 months

  • Airway resistance

    3 months

  • PSG measurement(AHI,etc.)

    3 months

  • Quality of Life

    3 months

  • Psychological status

    3 months

  • +1 more secondary outcomes

Study Arms (1)

CPAP

EXPERIMENTAL
Device: CPAP treatment

Interventions

CPAP treatmentDEVICE

maintains upper airway patency and minimizes the obstructive events

Also known as: REMstar(Respironics), SleepMate(ResMed)
CPAP

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects on admission for sleep study under the Respiratory Care and Sleep Control Medicine, Kyoto University Hospital.
  • Subjects diagnosed with OSA (apnea hypopnea index \>=20/hour) by overnight polysomnography.

You may not qualify if:

  • Known history of respiratory diseases that will affect airway inflammatory markers like asthma, chronic obstructive pulmonary disease and bronchiectasis.
  • Treatments with corticosteroids or other immunosuppressive drugs.

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, ObstructiveInflammation

Interventions

Continuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Positive-Pressure RespirationRespiration, ArtificialAirway ManagementTherapeuticsRespiratory Therapy

Study Officials

  • Kazuo Chin, MD,PhD

    Kyoto University, 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
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, Respiratory Care and Sleep Control Medicine, Kyoto University Graduate School of Medicine

Study Record Dates

First Submitted

October 27, 2008

First Posted

October 28, 2008

Study Start

January 1, 2009

Primary Completion

March 1, 2011

Study Completion

March 1, 2011

Last Updated

March 27, 2013

Record last verified: 2013-03

Locations

JP(1)