NCT00498732

Brief Summary

Specific Aim

  1. 1.To verify the differentially expressed genes and pathways between normal and OSA patients, and OSA patients before and after CPAP treatment.
  2. 2.To correlate the confirmed genes with the clinical presentations and CPAP effects in another 50 OSAS subjects to validate the altered gene expressions and pathways involved.
  3. 3.To establish a cell model to investigate the differentially expressed genes and the putative biological pathways involved in OSA syndrome.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2007

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

Study Start

First participant enrolled

June 1, 2007

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 8, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 10, 2007

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2008

Completed
Last Updated

December 1, 2010

Status Verified

November 1, 2010

Enrollment Period

9 months

First QC Date

July 8, 2007

Last Update Submit

November 30, 2010

Conditions

Keywords

Obstructive sleep apnea syndrome; CPAP, microarray

Interventions

CPAPDEVICE

CPAP treatment for 4 weeks

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

From patients who were referred to sleep lab for suspect sleep apnea, we selected 50 male patients with age\> 18 y/o. with severe OSAS, which were confirmed with by overnight PSG. All were free from neurologic events, chronic pulmonary disease, active infection and substance abuse. Female patients and patients under 18 y/o were excluded. All 50 subjects were treated with 4-week CPAP. All study subjects were admitted, on the day of baseline measurement and four weeks after CPAP use, for clinical evaluation, blood sampling and PSG. And all anti-hypertensive therapy was remained unchanged during the 4-week follow-up period. Changes of parameters, before and after CPAP treatment, were compared between two groups.

You may qualify if:

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

You may not qualify if:

  • 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)

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

MeSH Terms

Conditions

Sleep Apnea, ObstructiveMicrocephaly, Primary Autosomal Recessive, 6

Condition Hierarchy (Ancestors)

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

Study Officials

  • Peilin Lee, M.D.

    National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 8, 2007

First Posted

July 10, 2007

Study Start

June 1, 2007

Primary Completion

March 1, 2008

Study Completion

July 1, 2008

Last Updated

December 1, 2010

Record last verified: 2010-11

Locations