Novel Device for Screening Patients With Symptoms of OSA | NCT03157440

Studies
Novel Device for Screening Patients With Symptoms of OSA

NCT03157440

Sponsor

Chinese University of Hong Kong

Status

Completed

Last Update Posted

Apr 17, 2019Actual

Enrollment

97Actual

Phase

Not provided

Conditions

Sleep Apnea Syndromes

Interventions

Ring oxymetry

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

Apr 2019

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

Apr 1, 2017Actual

Primary Completion Date

Aug 31, 2017Actual

Completion Date

Mar 31, 2018Actual

First Submitted Date

May 16, 2017

First Submission Date that Met QC Criteria

May 16, 2017

First Posted Date

May 17, 2017Actual

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

Apr 16, 2019

Last Update Posted Date

Apr 17, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

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

An innovative ring type oxymetry will be wore by patient undergoing sleep study to validate it's accuracy and usefulness as a screening device for patients with symptoms of OSA

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

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

97Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ring oxymetry	Diagnostic Test	a new type oxymetry wear on index finger like a ring

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
the concordance of the ring oximetry with PSG as the gold standard		1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients above 18 years old and below 70 years old, both men and women

Exclusion Criteria:

Patients requiring oxygen therapy or noninvasive ventilation;
Patients with a diagnosis of chronic obstructive pulmonary disease, chronic heart failure, neuromuscular disease, insomnia, clinical symptoms of parasomnia, periodic limb movement, or narcolepsy.
Patients on medication known to interfere with heart rate, such as beta-blockers, digoxin or calcium receptor antagonists.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

patients with symptoms of OSA who will be undergoing sleep study for establishing a diagnosis

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Medicine and Therapeutics, Prince of Wales Hospital, CUHK		Hong Kong			Hong Kong

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