Skip to content

A validation study of the translated Stapesplasty Outcome Test 25 for measurement of disease-specific quality of life in Dutch otosclerosis patients

A validation study of the translated Stapesplasty Outcome Test 25 for measurement of disease-specific quality of life in Dutch otosclerosis patients

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON24075
Enrollment
120
Registered
2019-03-04
Start date
2018-11-08
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Otosclerosis

Interventions

None listed

Sponsors

None
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Inclusion criteria otosclerosis patients: - Age = 18; - Otosclerosis based on a clinical history of progressive hearing loss and pure-tone audiometry showing a conductive hearing loss with an air-bone gap of 15 dB nHL or more in the range of 500, 1000, 2000 and 4000 Hz; - Scheduled or on the waiting list for primary stapes surgery; - Willingness and ability to fulfill the questionnaires outlined in the research protocol; - Good understanding of the Dutch language. Inclusion criteria healthy controls: - Age between 30 and 60 years; - Willingness and ability to fulfill the questionnaires outlined in the research protocol; - Good understanding of the Dutch language.

Exclusion criteria

Exclusion criteria: Exclusion criteria otosclerosis patients: - Scheduled or on the waiting list for revision stapes surgery; - Disability that could interfere with audiometric evaluation and/or questionnaire fulfillment. Exclusion criteria healthy controls: - A history of hearing loss, ear disease (with the exception of uncomplicated acute otitis or otitis media with effusion in childhood) or previous middle ear surgery (with the exception of the placement of ventilation tubes in childhood); - Disability that could interfere with questionnaire fulfillment.

Design outcomes

Secondary

MeasureTime frame
Reliability and responsiveness of the translated SPOT-25

Primary

MeasureTime frame
Validity of the translated SPOT-25

Contacts

Public ContactInge Wegner

University Medical Center Utrecht

i.wegner@umcutrecht.nl+31887556644

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)