Obstructive Sleep ApneaSAS-SBNCT03747874
OSA and Sudden Sensorineural Hearing Loss
A study testing ventilatory polygraphy in people with Obstructive Sleep Apnea and Sudden Hearing Loss, run by Poitiers University Hospital at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obstructive Sleep Apnea, Sudden Hearing Loss
- What is being tested?
- ventilatory polygraphy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteFrance
- Study dates
- 19 Nov 2018to 12 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- past medical history of sudden hearing loss between 2010 and 2017
- no contraindication to a non supervised sleeping monitoring
Who cannot join
- past medical history of fluctuant hearing loss or pre-existant significative hearing loss
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prevalence of Obstructive Sleep Apnea Syndrome in Patients With a History of Sudden Sensorineural Hearing Loss
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.
- Conditions
- Obstructive Sleep Apnea, Sudden Hearing Loss
- Being tested
- ventilatory polygraphy
- Medical subject headings
- Sleep Apnea, Obstructive, Hearing Loss, Sudden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| past medical history of sudden hearing loss | Other | sleep examination and ventilatory polygraphy device for 1 night Receives: Diagnostic Test: ventilatory polygraphy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Study of the prevalence of OSA on patient with a history of sudden hearing loss
Measured: 1 night
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2018
- Study start19 Nov 2018
- Primary completion11 Dec 2018
- Study completion12 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Poitiers University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- ResMed
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03747874
- Sponsor's protocol ID
- SAS-SB
- Acronym
- SAS-SB
- Status last verified
- May 2020
- First submitted
- 17 Nov 2018
- Last updated
- 1 Jun 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Obstructive Sleep Apnea Syndrome in Patients With a History of Sudden Sensorineural Hearing Loss
- ClinicalTrials.gov ID
- NCT03747874
- Acronym / sponsor ID
- SAS-SB / SAS-SB
- Conditions
- Obstructive Sleep Apnea, Sudden Hearing Loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Poitiers University HospitalUniversity, hospital or other
- Collaborators
- ResMed
- Study start
- 19 Nov 2018 (actual)
- Primary completion
- 11 Dec 2018 (actual)
- Study completion
- 12 Dec 2018 (actual)
- First posted
- 20 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| past medical history of sudden hearing loss | Other | Diagnostic Test: ventilatory polygraphysleep examination and ventilatory polygraphy device for 1 night |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- past medical history of sudden hearing loss between 2010 and 2017
- no contraindication to a non supervised sleeping monitoring
Key exclusion criteria (1 listed)
- past medical history of fluctuant hearing loss or pre-existant significative hearing loss
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ventilatory polygraphywe 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 | Diagnostic test | past medical history of sudden hearing loss |
Primary outcome
Study of the prevalence of OSA on patient with a history of sudden hearing loss
Time frame: 1 night
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ventilatory polygraphy in people with Obstructive Sleep Apnea and Sudden Hearing Loss, run by Poitiers University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Study of the prevalence of OSA on patient with a history of sudden hearing loss (time frame: 1 night). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2020.