Long Term Cardiovascular Complications in Men With Obstru... | NCT01475682

Studies
Long Term Cardiovascular Complications in Men With Obstructive Sleep Apnea

NCT01475682

Sponsor

The University of Hong Kong

Status

Unknown status

Last Update Posted

Jul 17, 2014Estimated

Enrollment

167Estimated

Phase

Not provided

Conditions

Obstructive Sleep Apnea
Cardiovascular Diseases
Metabolic Diseases

Interventions

Not provided

Countries

Hong Kong

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2014

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2011

Primary Completion Date

May 2015Estimated

Completion Date

May 2015Estimated

First Submitted Date

Nov 16, 2011

First Submission Date that Met QC Criteria

Nov 18, 2011

First Posted Date

Nov 21, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 16, 2014

Last Update Posted Date

Jul 17, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Lam Jamie Chung Mei, Honorary Clinical Assistant Professor, The University of Hong KongPrincipal Investigator

Lead Sponsor

The University of Hong KongOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Primary outcome:

Incidence of cardiometabolic diseases in subjects with OSA over 9 years.
Secondary outcomes:

Effects of CPAP treatment on cardiometabolic conditions

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

167Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Effects of CPAP treatment on cardiometabolic conditions		9 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

From previous cohort for reassessment.

Exclusion Criteria:

Unstable medical conditions

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jamie C Lam, MD	Contact	852-22555906		lamcmj@hku.hk

Overall Officials

Name	Affiliation	Role
Jamie C Lam, MD	The University of Hong Kong	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Queen Mary Hospital	Recruiting	Hong Kong			Hong Kong

Condition Browse Module

MeSH Terms

ID	Term
D020181	Sleep Apnea, Obstructive
D002318	Cardiovascular Diseases
D008659	Metabolic Diseases

Ancestor Terms

ID	Term
D012891	Sleep Apnea Syndromes
D001049	Apnea
D012120	Respiration Disorders
D012140	Respiratory Tract Diseases

Browse Leaves

Not provided

Browse Branches

Not provided