Sleep DisordersSoMNCT07299578
Sleep Disorders and Their Impact on Patients With Ménière's Disease
An observational study of Sleep Disorders, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
Ménière's disease was first described by Prosper Ménière in 1861 as a balance disorder originating in the inner ear. It is diagnosed based on a characteristic clinical triad of low-frequency hearing loss, tinnitus, and vertigo attacks. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sleep Disorders
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 19 Jul 2024to Jan 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Adult (≥18 years) followed for Ménière's disease in the ENT department at Strasbourg University Hospital between June 1, 2019, and January 31, 2021.
Who may be able to join
- Adult (≥18 years)
- Patient followed for Ménière's disease in the ENT department at Strasbourg University Hospital between June 1, 2019, and January 31, 2021.
Who cannot join
- History of intracranial surgery or degenerative neurological disease.
- No prior sleep medicine consultations.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Service d'ORL et de Chirurgie Cervico-faciale - Hôpitaux Universitaires de Strasbourg
Strasbourg, 67091
Anne CHARPIOT, MD, PhD, 33 3 88 12 76 41, anne.charpiot@chru-strasbourg.fr
Anne CHARPIOT, MD, PhD
About this study
Official title: A Study of Sleep Disorders and Their Impact on Patients With Ménière's Disease
Ménière's disease was first described by Prosper Ménière in 1861 as a balance disorder originating in the inner ear. It is diagnosed based on a characteristic clinical triad of low-frequency hearing loss, tinnitus, and vertigo attacks. The underlying cause is thought to be a pressure imbalance in the inner ear between the endolymphatic and perilymphatic sectors.
The prevalence of Ménière's disease ranges from 34 to 190 per 100,000 inhabitants.
Read more
The physiology of Ménière's disease is not yet fully understood. It appears that sleep disorders may be related.
In its 2016 report on Ménière's disease, the French Society of Otolaryngology (SÖL) recommends sleep studies for patients with Ménière's disease.
However, these recommendations are based on few studies, which is why we wanted to conduct this research.
The main hypothesis is the existence of a link between debilitating vertigo and sleep disturbances in patients with Ménière's disease.
In cases of more significant sleep disturbances in patients with debilitating Ménière's disease, it is important to focus more thoroughly on these disturbances during ENT consultations, which are an integral part of effective multidisciplinary care.
- Conditions
- Sleep Disorders
- Keywords
- Sleep Disorder, Ménière's Disease
- Medical subject headings
- Sleep Wake Disorders, Meniere Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Vertigo-related disability Score AAO-HNS
- Vertigo-related disability score AAO-HNS (American Academy of Otolaryngology-Head and Neck Surgery Functional Scale)
- Vertigo is considered debilitating if the score is greater than 3 out of 6.
Measured: 1 hour after consultation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2025
- Study start19 Jul 2024
- Primary completionJan 2026 (estimated)
- Study completionJan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep DisordersStudies 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-control
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07299578
- Sponsor's protocol ID
- 9380
- Acronym
- SoM
- Status last verified
- Dec 2025
- First submitted
- 9 Dec 2025
- Last updated
- 23 Dec 2025
- 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 23 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of Sleep Disorders and Their Impact on Patients With Ménière's Disease
- ClinicalTrials.gov ID
- NCT07299578
- Acronym / sponsor ID
- SoM / 9380
- Conditions
- Sleep Disorders
- Keywords
- Sleep Disorder, Ménière's Disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 19 Jul 2024 (actual)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Jan 2026 (estimated)
- First posted
- 23 Dec 2025 (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.
Ménière's disease was first described by Prosper Ménière in 1861 as a balance disorder originating in the inner ear. It is diagnosed based on a characteristic clinical triad of low-frequency hearing loss, tinnitus, and vertigo attacks. The underlying cause is thought to be a pressure imbalance in the inner ear between the endolymphatic and perilymphatic sectors.
The prevalence of Ménière's disease ranges from 34 to 190 per 100,000 inhabitants.
The physiology of Ménière's disease is not yet fully understood. It appears that sleep disorders may be related.
In its 2016 report on Ménière's disease, the French Society of Otolaryngology (SÖL) recommends sleep studies for patients with Ménière's disease.
However, these recommendations are based on few studies, which is why we wanted to conduct this research.
The main hypothesis is the existence of a link between debilitating vertigo and sleep disturbances in patients with Ménière's disease.
In cases of more significant sleep disturbances in patients with debilitating Ménière's disease, it is important to focus more thoroughly on these disturbances during ENT consultations, which are an integral part of effective multidisciplinary care.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Adult (≥18 years) followed for Ménière's disease in the ENT department at Strasbourg University Hospital between June 1, 2019, and January 31, 2021.
Key inclusion criteria (2 listed)
- Adult (≥18 years)
- Patient followed for Ménière's disease in the ENT department at Strasbourg University Hospital between June 1, 2019, and January 31, 2021.
Key exclusion criteria (2 listed)
- History of intracranial surgery or degenerative neurological disease.
- No prior sleep medicine consultations.
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
Vertigo-related disability Score AAO-HNS
Time frame: 1 hour after consultation
* Vertigo-related disability score AAO-HNS (American Academy of Otolaryngology-Head and Neck Surgery Functional Scale) * Vertigo is considered debilitating if the score is greater than 3 out of 6.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2025.
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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.
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 Sleep Disorders, 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 2 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 23 Dec 2025. 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?
This study is still under way. Results are not available in the source record yet.
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?
Vertigo-related disability Score AAO-HNS (time frame: 1 hour after consultation). 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 23 Dec 2025.