NCT00491088

Brief Summary

Specific Aim:

  1. 1.To prove our hypothesis that in severe OSA patients without daytime sleepiness, CPAP worked as effectively as in severe OSA patients with daytime sleepiness.
  2. 2.To establish a model to predict the CPAP effect We use the parameters of five aspects, including changes of polysomnographic parameters, improvement of sleepiness, fatigue and QOL, sympathetic activity, inflammatory mediators and metabolism, to establish a model to predict CPAP effect.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
96

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2007

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

Study Start

First participant enrolled

June 1, 2007

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

June 21, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 25, 2007

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

March 1, 2010

Status Verified

February 1, 2010

Enrollment Period

2.2 years

First QC Date

June 21, 2007

Last Update Submit

February 25, 2010

Conditions

Sleep Apnea, Obstructive

Outcome Measures

Primary Outcomes (1)

  • improvement of sleepiness

    after 4-week and 12-week CPAP treatment

Secondary Outcomes (1)

  • improvement of fatigue and QOL, sympathetic activity, inflammatory mediators and metabolism

    after 4-week and 12-week CPAP treatment

Interventions

CPAPDEVICE

CPAP for 12 weeks

Eligibility Criteria

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

You may qualify if:

  • Severe obstructive sleep apnea (AHI\>=30/hr) age, sex, BMI match control subject

You may not qualify if:

  • Patients were excluded when they:
  • Refused to participate in this study
  • Had severe obstructive pulmonary disease or active neurological events
  • Enrolled in other studies at the same time

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Naitonal Taiwan University Hospital

Taipei, 100, Taiwan

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Study Officials

  • Whey Dong Wu, M.D.

    National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

  • Peilin Lee, M.D.

    National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 21, 2007

First Posted

June 25, 2007

Study Start

June 1, 2007

Primary Completion

August 1, 2009

Study Completion

December 1, 2009

Last Updated

March 1, 2010

Record last verified: 2010-02

Locations

TW(1)