Validation of Portable Monitoring Device for Diagnosing S... | NCT00628511

Studies
Validation of Portable Monitoring Device for Diagnosing Sleep Apnea

NCT00628511

Sponsor

Chinese University of Hong Kong

Status

Completed

Last Update Posted

Feb 9, 2016Estimated

Enrollment

175Actual

Phase

Not provided

Conditions

Sleep Apnea

Interventions

ARES (Apnea Risk Evaluation System)

Countries

China

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

Feb 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2007

Primary Completion Date

Dec 2007Actual

Completion Date

Feb 2008Actual

First Submitted Date

Feb 6, 2008

First Submission Date that Met QC Criteria

Feb 25, 2008

First Posted Date

Mar 5, 2008Estimated

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

Feb 8, 2016

Last Update Posted Date

Feb 9, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

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

portable monitoring device could diagnose sleep apnea in high risk patients.

Detailed Description

This is a pilot study of another larger cohort investigating different algorithms in managing patients suspected of sleep apnea using portable monitoring device.

Portable monitoring device is applied simultaneously with PSG to compare it's accuracy and validity.

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

No data available

No data is available for this block.

Biospecimen

No data available

No data is available for this block.

Enrollment

175Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
observation			Device: ARES (Apnea Risk Evaluation System)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ARES (Apnea Risk Evaluation System)	Device	application of portable monitoring device with PSG	observation

Measure	Description	Time Frame
validity of portable monitoring device		1 year

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients suspected of sleep apnea

Exclusion Criteria:

patient refuse to participate

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

patients suspected of sleep apnea

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
To K Wang, MBCHB	Chinese University of Hong Kong	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The Chinese Univerisity of Hong Kong		Hong Kong			China

Condition Browse Module

MeSH Terms

ID	Term
D012891	Sleep Apnea Syndromes

Ancestor Terms

ID	Term
D001049	Apnea
D012120	Respiration Disorders
D012140	Respiratory Tract Diseases
D020919	Sleep Disorders, Intrinsic

Browse Leaves

Not provided

Browse Branches

Not provided