NCT00942110

Brief Summary

The purpose of this study is to examine postprandial glucose and lipid metabolism in patients with obstructive sleep apnea.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
58

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 17, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 20, 2009

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2009

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
Last Updated

March 6, 2012

Status Verified

March 1, 2012

Enrollment Period

2.2 years

First QC Date

July 17, 2009

Last Update Submit

March 5, 2012

Conditions

Obstructive Sleep Apnea

Keywords

Postprandial glucose, lipid metabolismhumoral factors

Outcome Measures

Primary Outcomes (1)

  • postprandial metabolic markers including glucose, cholesterol, triglyceride, ghrelin, leptin

    baseline and 3 months after CPAP

Secondary Outcomes (7)

  • respiratory events (ie. apnea-hypopnea index)

    baseline and 3 months after CPAP

  • inflammatory biomarkers (ie. IL-6, CRP)

    baseline and 3 months after CPAP

  • quality of life

    baseline and 3 months after CPAP

  • sleep quality

    baseline and 3 months after CPAP

  • sympathetic activity in urine

    baseline and 3 months after CPAP

  • +2 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), Auto Set(Resmed), Goodnight (Tyco Healthcare)
CPAP

Eligibility Criteria

Age20 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 \>=5/hour) by overnight polysomnography.

You may not qualify if:

  • Subjects treating for acute infections or malignancy.
  • Subjects with severe anemia, diabetes,and renal failure.

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, Obstructive

Interventions

Continuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration 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 University, Graduate School of Medicine

    PRINCIPAL INVESTIGATOR

  • Yuichi Chihara, 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
Medical doctor

Study Record Dates

First Submitted

July 17, 2009

First Posted

July 20, 2009

Study Start

September 1, 2009

Primary Completion

December 1, 2011

Study Completion

March 1, 2012

Last Updated

March 6, 2012

Record last verified: 2012-03

Locations

JP(1)