Back to resultsOSA and Sudden Sensorineural Hearing Loss (SAS-SB)
Primary Purpose
Obstructive Sleep Apnea, Sudden Hearing Loss
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
ventilatory polygraphy
Sponsored by
About this trial
This is an interventional screening trial for Obstructive Sleep Apnea
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
Sites / Locations
- Dufour Xavier
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
past medical history of sudden hearing loss
Arm Description
sleep examination and ventilatory polygraphy device for 1 night
Outcomes
Primary Outcome Measures
Study of the prevalence of OSA on patient with a history of sudden hearing loss
Secondary Outcome Measures
Full Information
NCT ID
NCT03747874
First Posted
November 17, 2018
Last Updated
May 29, 2020
Sponsor
Poitiers University Hospital
Collaborators
ResMed
1. Study Identification
Unique Protocol Identification Number
NCT03747874
Brief Title
OSA and Sudden Sensorineural Hearing Loss
Acronym
SAS-SB
Official Title
Prevalence of Obstructive Sleep Apnea Syndrome in Patients With a History of Sudden Sensorineural Hearing Loss
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
November 19, 2018 (Actual)
Primary Completion Date
December 11, 2018 (Actual)
Study Completion Date
December 12, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Poitiers University Hospital
Collaborators
ResMed
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea, Sudden Hearing Loss
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
past medical history of sudden hearing loss
Arm Type
Other
Arm Description
sleep examination and ventilatory polygraphy device for 1 night
Intervention Type
Diagnostic Test
Intervention Name(s)
ventilatory polygraphy
Intervention Description
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
Primary Outcome Measure Information:
Title
Study of the prevalence of OSA on patient with a history of sudden hearing loss
Time Frame
1 night
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Dufour Xavier
City
Poitiers
ZIP/Postal Code
86000
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
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OSA and Sudden Sensorineural Hearing Loss
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