Peripheral Vestibular DisorderCSLNCT05149482
Isolated Deficits of the Lateral Semicircular Canal
An observational study of Peripheral Vestibular Disorder, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
There are only a few cases of isolated lateral canal deficit described in the literature. This study would focus on this group of patients in order to establish an evolving profile, a recovery behavior that we could compare to that in the literature. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Vestibular Disorder
- How many people
- 12 participants
- Where
- 1 siteFrance
- Study dates
- 1 Sep 2021to 30 Nov 2022
- Phase
- Observational
- 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
- Adult, Older adult
Study population: Patient treated in the ENT department for dizziness between June 2020 and July 2021.
Who may be able to join
- Major patient
- Man or woman
- Patient who has given their consent to the use of their data.
- Patient treated in the ENT department for dizziness between June 2020 and July 2021.
- Non-inclusion criteria
- Patient who expressed his opposition to participating in the study
Show all 10Show fewer
- Inability to provide the subject with enlightened information (difficulties in understanding the subject, cognitive disorders)
- Subject under safeguard of justice
- Subject under guardianship or guardianship
- Neurological signs on clinical examination
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Saïd CHAYER, PhD, HDR contact
France1 site, 1 recruiting
- Recruiting
Oto-rhino-laryngologie et Chirurgie cervico-faciale - Hôpitaux Universitaires de Strasbourg
Strasbourg, 67091
Anne CHARPIOT, MD, PhD, 33 3 88 12 76 41, anne.charpiot@chru-strasbourg.fr
Saïd CHAYER, PhD, HDR, said.chayer@chru-strasbourg.fr
About this study
Official title: Evolutionary Profile of Isolated Lateral Semicircular Canal Deficits on the Video Head Impulsed Test (VHIT)
There are only a few cases of isolated lateral canal deficit described in the literature. This study would focus on this group of patients in order to establish an evolving profile, a recovery behavior that we could compare to that in the literature.
In addition, the evolving profile as well as the other clinical criteria identified would allow investigators to make hypotheses as to the pathology responsible for a given evolutionary profile.
The population studied is represented by adult patients admitted by the emergency consultation service of otolaryngology of the University Hospitals of Strasbourg for an acute unilateral vestibular deficit whose examination at the VHOT shows a reduced and isolated gain of a lateral semicircular canal.
- Conditions
- Peripheral Vestibular Disorder
- Keywords
- Peripheral Vestibular Disorder, Lateral semicircular canal, Video Head Impulsed Test
What is being measured
The primary outcome is the main question the study is designed to answer.
Establish the evolutionary profiles of patients with isolated lateral canal involvement
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2021
- Study start1 Sep 2021
- Primary completionNov 2022 (estimated)
- Study completion30 Nov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Vestibular DisorderStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anne CHARPIOT, MD, PhD, Principal investigator, Oto-rhino-laryngologie et Chirurgie cervico-faciale - Hôpitaux Universitaires de Strasbourg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05149482
- Sponsor's protocol ID
- 8397
- Acronym
- CSL
- Status last verified
- Nov 2021
- First submitted
- 24 Nov 2021
- Last updated
- 8 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evolutionary Profile of Isolated Lateral Semicircular Canal Deficits on the Video Head Impulsed Test (VHIT)
- ClinicalTrials.gov ID
- NCT05149482
- Acronym / sponsor ID
- CSL / 8397
- Conditions
- Peripheral Vestibular Disorder
- Keywords
- Peripheral Vestibular Disorder, Lateral semicircular canal, Video Head Impulsed Test
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- Nov 2022 (estimated)
- Study completion
- 30 Nov 2022 (estimated)
- First posted
- 8 Dec 2021 (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.
There are only a few cases of isolated lateral canal deficit described in the literature. This study would focus on this group of patients in order to establish an evolving profile, a recovery behavior that we could compare to that in the literature.
In addition, the evolving profile as well as the other clinical criteria identified would allow investigators to make hypotheses as to the pathology responsible for a given evolutionary profile.
The population studied is represented by adult patients admitted by the emergency consultation service of otolaryngology of the University Hospitals of Strasbourg for an acute unilateral vestibular deficit whose examination at the VHOT shows a reduced and isolated gain of a lateral semicircular canal.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patient treated in the ENT department for dizziness between June 2020 and July 2021.
Key inclusion criteria (10 listed)
- Major patient
- Man or woman
- Patient who has given their consent to the use of their data.
- Patient treated in the ENT department for dizziness between June 2020 and July 2021.
- Non-inclusion criteria
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Establish the evolutionary profiles of patients with isolated lateral canal involvement
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2021.
Related trials for Peripheral Vestibular Disorder
Enrolling by invitationObservational study
Long Term Follow-up Study of AAVAnc80-antiVEGF Gene Therapy
Vestibular Schwannoma
RecruitingPhase 1/2
Anti-VEGF Gene Therapy Trial for Vestibular Schwannoma
Vestibular Schwannoma
Not yet recruitingPhase 2
Selumetinib for NF2-Related Schwannomatosis
Neurofibromatosis Type 2, NF2
RecruitingPhase 2
Innovative Trial for Understanding the Impact of Targeted Therapies in NF2-Related Schwannomatosis (INTUITT-NF2)
Neurofibromatosis Type 2, Vestibular Schwannoma
RecruitingPhase 3
Steroids for Facial Nerve Function Protection in Post-surgical Vestibular Schwannoma Patients
Vestibular Schwannoma, Facial Nerve Paralysis
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.
Saïd CHAYER, PhD, HDR contact
Anne CHARPIOT, MD, PhD principal investigator
Oto-rhino-laryngologie et Chirurgie cervico-faciale - Hôpitaux Universitaires de Strasbourg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peripheral Vestibular Disorder, run by University Hospital, Strasbourg, France 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 10 inclusion and 0 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: status not confirmed, as of the sponsor's last update on 8 Dec 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anne CHARPIOT, MD, PhD (33 3 88 12 76 41, anne.charpiot@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Establish the evolutionary profiles of patients with isolated lateral canal involvement (time frame: 1 month). 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 8 Dec 2021.