Evaluation of a Disposable Sound Sensor for Recording Res... | NCT05272449

Studies
Evaluation of a Disposable Sound Sensor for Recording Respiration During Sleep

NCT05272449

Sponsor

CIDELEC

Status

Unknown status

Last Update Posted

Mar 9, 2022Actual

Enrollment

20Estimated

Phase

Not Applicable

Conditions

Sleep Apnea (Disorder)

Interventions

Sleep apnea diagnosis

Countries

Not provided

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

Annotation Module

Unposted Annotation

Unposted Responsible Party

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 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 28, 2022Estimated

Primary Completion Date

Apr 28, 2022Estimated

Completion Date

Apr 28, 2022Estimated

First Submitted Date

Feb 17, 2022

First Submission Date that Met QC Criteria

Feb 28, 2022

First Posted Date

Mar 9, 2022Actual

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 28, 2022

Last Update Posted Date

Mar 9, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

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

Split-night prospective monocentric study to evaluate, in real conditions, the effectiveness of a disposable tracheal sound sensor.

Detailed Description

Not provided

Design Module

Study Type

Interventional

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 Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Evaluation of a disposable sound sensor for recording respiration during sleep	Experimental	PneaVoX sensor, CIDELEC	Device: Sleep apnea diagnosis

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Sleep apnea diagnosis	Device	Split-night	Evaluation of a disposable sound sensor for recording respiration during sleep

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Analyzable signal time	Percentage of the analyzable signal duration compared to the total recorded signal duration	One night

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with suspected obstructive sleep apnea

Exclusion Criteria:

Lung infection
Insomnia

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Type	Date	Date Unknown
Release	Dec 13, 2022
Reset	Oct 12, 2023

Submission Tracking

Estimated Results First Submitted Date

Dec 13, 2022

First MCP Posted Date

Not provided

Submission Infos

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Dec 13, 2022			Oct 12, 2023

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