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出境医 / 临床实验 / Dizziness Among First Time Users of Hearing Aids
Dizziness Among First Time Users of Hearing Aids
Study Description
Brief Summary:
The score on the Dizziness Handicap Inventory (short version) before and after hearing aid fitting and usage will be compared
| Condition or disease | Intervention/treatment |
|---|---|
| Dizziness Hearing Loss | Device: Hearing aids |
Study Design
| Study Type : | Observational |
| Estimated Enrollment : | 60 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | Dizziness Among First Time Users of Hearing Aids |
| Estimated Study Start Date : | September 1, 2019 |
| Estimated Primary Completion Date : | May 30, 2020 |
| Estimated Study Completion Date : | May 30, 2020 |
Arms and Interventions
| Group/Cohort | Intervention/treatment |
|---|---|
|
First time users of hearing aids
Hearing aid fitting and usage
|
Device: Hearing aids
Fitting of hearing aids (for the first time)
|
Outcome Measures
Primary Outcome Measures :
- 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
Secondary Outcome Measures :
- Usage of hearing aids [ Time Frame: 2 months ]The duration the participants used the hearing aids
Eligibility Criteria
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
18 years and older patients using hearing aids for the first time
Criteria
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
Contacts and Locations
Contacts
| Contact: Yahav Oron, MD | 972-3-5772450 | orony@clalit.org.il |
Sponsors and Collaborators
Clalit Health Services
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date | June 2, 2019 | ||||
| First Posted Date | June 4, 2019 | ||||
| Last Update Posted Date | July 30, 2019 | ||||
| Estimated Study Start Date | September 1, 2019 | ||||
| Estimated Primary Completion Date | May 30, 2020 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures |
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
|
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| Original Primary Outcome Measures |
Dizziness Handicap Inventory (short version) score [ Time Frame: 2 months ] The change in the score a 2 months after fitting the hearing aids
|
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| Change History | |||||
| Current Secondary Outcome Measures |
Usage of hearing aids [ Time Frame: 2 months ] The duration the participants used the hearing aids
|
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| Original Secondary Outcome Measures | Same as current | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title | Dizziness Among First Time Users of Hearing Aids | ||||
| Official Title | Dizziness Among First Time Users of Hearing Aids | ||||
| Brief Summary | The score on the Dizziness Handicap Inventory (short version) before and after hearing aid fitting and usage will be compared | ||||
| Detailed Description | Not Provided | ||||
| Study Type | Observational | ||||
| Study Design | Observational Model: Cohort Time Perspective: Prospective |
||||
| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | 18 years and older patients using hearing aids for the first time | ||||
| Condition |
|
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| Intervention | Device: Hearing aids
Fitting of hearing aids (for the first time)
|
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| Study Groups/Cohorts | First time users of hearing aids
Hearing aid fitting and usage
Intervention: Device: Hearing aids
|
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| Publications * | Not Provided | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status | Unknown status | ||||
| Estimated Enrollment |
60 | ||||
| Original Estimated Enrollment | Same as current | ||||
| Estimated Study Completion Date | May 30, 2020 | ||||
| Estimated Primary Completion Date | May 30, 2020 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
|
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| Sex/Gender |
|
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| Ages | 18 Years and older (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries | Not Provided | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number | NCT03973658 | ||||
| Other Study ID Numbers | 0132-18-COM2 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| U.S. FDA-regulated Product |
|
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| IPD Sharing Statement |
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| Responsible Party | Clalit Health Services | ||||
| Study Sponsor | Clalit Health Services | ||||
| Collaborators | Not Provided | ||||
| Investigators | Not Provided | ||||
| PRS Account | Clalit Health Services | ||||
| Verification Date | May 2019 | ||||
