OSA and Sudden Sensorineural Hearing Loss | NCT03747874

Studies
OSA and Sudden Sensorineural Hearing Loss

NCT03747874

Sponsor

Poitiers University Hospital

Status

Completed

Last Update Posted

Jun 1, 2020Actual

Enrollment

10Actual

Phase

Not Applicable

Conditions

Obstructive Sleep Apnea
Sudden Hearing Loss

Interventions

ventilatory polygraphy

Countries

France

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

May 2020

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

Nov 19, 2018Actual

Primary Completion Date

Dec 11, 2018Actual

Completion Date

Dec 12, 2018Actual

First Submitted Date

Nov 17, 2018

First Submission Date that Met QC Criteria

Nov 17, 2018

First Posted Date

Nov 20, 2018Actual

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

May 29, 2020

Last Update Posted Date

Jun 1, 2020Actual

Name	Class
ResMed	INDUSTRY

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

This study studies the prevalence between obstructive sleep apnea syndrome and sensorineural hearing loss. We recruit patients who have been treated for sudden sensorineural hearing loss in Poitiers' University Hospital between 2010 et 2017, and we detect if they have OSA with a ventilatory polygraphy.

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

10Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
past medical history of sudden hearing loss	Other	sleep examination and ventilatory polygraphy device for 1 night	Diagnostic Test: ventilatory polygraphy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ventilatory polygraphy	Diagnostic Test	we put a ventilatory polygraphy device on the patient in the evening, they come back home to sleep while the device is recording ventilatory parameters and they come back the morrow to give the device back

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Study of the prevalence of OSA on patient with a history of sudden hearing loss		1 night

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

past medical history of sudden hearing loss between 2010 and 2017
no contraindication to a non supervised sleeping monitoring

Exclusion Criteria:

past medical history of fluctuant hearing loss or pre-existant significative hearing loss

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

Facility	Status	City	State	ZIP	Country	Contacts
Dufour Xavier		Poitiers		86000	France

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D020181	Sleep Apnea, Obstructive
D003639	Hearing Loss, Sudden

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