- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03973658
Dizziness Among First Time Users of Hearing Aids
July 29, 2019 updated by: Clalit Health Services
The score on the Dizziness Handicap Inventory (short version) before and after hearing aid fitting and usage will be compared
Study Overview
Study Type
Observational
Enrollment (Anticipated)
60
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
18 years and older patients using hearing aids for the first time
Description
Inclusion Criteria:
- Hebrew speaking
- First time users of hearing aids
Exclusion Criteria:
- Using a wheelchair
- Neurological disorders
- Spine of leg surgery in the previous 6 months
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
First time users of hearing aids
Hearing aid fitting and usage
|
Fitting of hearing aids (for the first time)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Dizziness Handicap Inventory (short version) score. The scale measures the degree of dizziness associated handicap as experienced by the patient. Minimun score: 0 Maximum score: 13. A higher score means better outcome.
Time Frame: 2 months
|
The change in the score a 2 months after fitting the hearing aids
|
2 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Usage of hearing aids
Time Frame: 2 months
|
The duration the participants used the hearing aids
|
2 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ANTICIPATED)
September 1, 2019
Primary Completion (ANTICIPATED)
May 30, 2020
Study Completion (ANTICIPATED)
May 30, 2020
Study Registration Dates
First Submitted
June 2, 2019
First Submitted That Met QC Criteria
June 2, 2019
First Posted (ACTUAL)
June 4, 2019
Study Record Updates
Last Update Posted (ACTUAL)
July 30, 2019
Last Update Submitted That Met QC Criteria
July 29, 2019
Last Verified
May 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0132-18-COM2
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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