- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07922447
Functional Impact of Psychological Symptoms in Patients With Superior Semicircular Canal Dehiscence Syndrome (SSCD): a National Cross-sectional Study (SDCS-PSY)
Superior semicircular canal dehiscence syndrome (SSCD), also known as Minor syndrome, is a rare otoneurological condition characterized by auditory and vestibular symptoms. Emerging evidence suggests a significant psychological burden, including anxiety, depressive symptoms, and suicidal ideation, potentially related to diagnostic delay and chronic symptomatology. However, no structured epidemiological study has systematically assessed quality of life and psychological symptoms in this population.
The aim of this study is to evaluate quality of life and associated psychological symptoms in adults reporting a diagnosis of SSCD using validated self-reported questionnaires in a national cross-sectional survey.
Studieoversikt
Status
Studietype
Registrering (Antatt)
Kontakter og plasseringer
Studiekontakt
- Navn: Valentin RAYMOND, Dr
- Telefonnummer: +33 5.61.77.73.15
- E-post: raymond.v@chu-toulouse.fr
Studer Kontakt Backup
- Navn: Clémence LE BERVET
- Telefonnummer: +33 5 61 77 70 87
- E-post: lebervet.c@chu-toulouse.fr
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Patient selection was based on internal communication to members by the French association of patients with Mineur syndrome.
The study was disseminated through specialized consultations.
Beskrivelse
Inclusion Criteria:
- Age ≥ 18 years
- Self-reported diagnosis of superior semicircular canal dehiscence syndrome
- Ability to understand French
- Non-opposition to participation
Exclusion Criteria:
- Refusal of data use for research purposes
- Self-reported cognitive impairment preventing questionnaire completion
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Observasjonsmodeller: CASE_ONLY
- Tidsperspektiver: CROSS_SECTIONAL
Kohorter og intervensjoner
Gruppe / Kohort |
|---|
|
patients with superior semicircular canal dehiscence syndrome
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Overall quality of life score measured using the WHOQOL-BREF questionnaire
Tidsramme: The inclusion day
|
The inclusion day
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Assessment of the prevalence of depressive symptoms in patients living with CSDS using the average score found on the Beck Depression Inventory (BDI) scale
Tidsramme: The inclusion day
|
The inclusion day
|
|
Assessment of the prevalence of anxiety symptoms in patients living with CSDS using the mean score found on the State-Trait Anxiety Inventory (STAI-Y)
Tidsramme: The inclusion day
|
The inclusion day
|
|
Assessment of the symptomatic intensity level of each symptom of the SDCS using an average score per item and an overall average score on the Naert questionnaire
Tidsramme: The inclusion day
|
The inclusion day
|
|
Assessment of the impact of vestibular symptoms on the functioning of patients living with CSDS using the average score found on the Dizziness Handicap Inventory (DIH) scale
Tidsramme: The inclusion day
|
The inclusion day
|
|
Assessment of the level of hopelessness in patients living with SDCS using the average score found on the Beck Hopelessness Scale (BHS)
Tidsramme: The inclusion day
|
The inclusion day
|
|
To assess the difference in quality of life between adult patients who underwent surgical management of their CSSD and others using the WHOQOL-BREF score
Tidsramme: The inclusion day
|
The inclusion day
|
Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- RC31/26/0193
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
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