NCT01475682

Brief Summary

Subjects with Obstructive Sleep Apnea (OSA) are at increased risk of developing cardiometabolic complications, and effective long-term nCPAP treatment significantly reduces the risk of cardiovascular morbidity and mortality.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
167

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2011

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

November 1, 2011

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

November 16, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 21, 2011

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

July 17, 2014

Status Verified

July 1, 2014

Enrollment Period

3.5 years

First QC Date

November 16, 2011

Last Update Submit

July 16, 2014

Conditions

Obstructive Sleep ApneaCardiovascular DiseasesMetabolic Diseases

Keywords

Obstructive sleep apneacardiometabolic complicationsEffects of CPAP treatment

Outcome Measures

Primary Outcomes (1)

  • Incidence of cardiometabolic complications

    167 subjects recruited from our previous "OSA and metabolic syndrome" (OSAMS) cohort from October 2002 to June 2007 will be invited to be reassessed at this time point.

    9 years

Secondary Outcomes (1)

  • Effects of CPAP treatment on cardiometabolic conditions

    9 years

Study Arms (1)

1

167 subjects recruited from our previous "OSA and metabolic syndrome" (OSAMS) cohort from October 2002 to June 2007 will be invited to be reassessed at this time point.

Eligibility Criteria

Age18 Years - 65 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

167 subjects recruited from our previous "OSA and metabolic syndrome" (OSAMS) cohort from October 2002 to June 2007 will be invited to be reassessed at this time point.

You may qualify if:

  • From previous cohort for reassessment.

You may not qualify if:

  • Unstable medical conditions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Queen Mary Hospital

Hong Kong, Hong Kong

RECRUITING

MeSH Terms

Conditions

Sleep Apnea, ObstructiveCardiovascular DiseasesMetabolic Diseases

Condition Hierarchy (Ancestors)

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

Study Officials

  • Jamie C Lam, MD

    The University of Hong Kong

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jamie C Lam, MD

CONTACT

852-22555906lamcmj@hku.hk

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Honorary Clinical Assistant Professor

Study Record Dates

First Submitted

November 16, 2011

First Posted

November 21, 2011

Study Start

November 1, 2011

Primary Completion

May 1, 2015

Study Completion

May 1, 2015

Last Updated

July 17, 2014

Record last verified: 2014-07

Locations

HK(1)