NCT03747874

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 17, 2018

Completed
2 days until next milestone

Study Start

First participant enrolled

November 19, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 20, 2018

Completed
21 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 11, 2018

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 12, 2018

Completed
Last Updated

June 1, 2020

Status Verified

May 1, 2020

Enrollment Period

22 days

First QC Date

November 17, 2018

Last Update Submit

May 29, 2020

Conditions

Obstructive Sleep ApneaSudden Hearing Loss

Outcome Measures

Primary Outcomes (1)

  • Study of the prevalence of OSA on patient with a history of sudden hearing loss

    1 night

Study Arms (1)

past medical history of sudden hearing loss

OTHER

sleep examination and ventilatory polygraphy device for 1 night

Diagnostic Test: ventilatory polygraphy

Interventions

ventilatory polygraphyDIAGNOSTIC_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

past medical history of sudden hearing loss

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dufour Xavier

Poitiers, 86000, France

Location

MeSH Terms

Conditions

Sleep Apnea, ObstructiveHearing Loss, Sudden

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesHearing LossHearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 17, 2018

First Posted

November 20, 2018

Study Start

November 19, 2018

Primary Completion

December 11, 2018

Study Completion

December 12, 2018

Last Updated

June 1, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)