NCT03973658

Brief Summary

The score on the Dizziness Handicap Inventory (short version) before and after hearing aid fitting and usage will be compared

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2019

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 2, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 4, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

September 1, 2019

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2020

Completed
Last Updated

July 30, 2019

Status Verified

May 1, 2019

Enrollment Period

9 months

First QC Date

June 2, 2019

Last Update Submit

July 29, 2019

Conditions

DizzinessHearing Loss

Outcome Measures

Primary Outcomes (1)

  • 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.

    The change in the score a 2 months after fitting the hearing aids

    2 months

Secondary Outcomes (1)

  • Usage of hearing aids

    2 months

Study Arms (1)

First time users of hearing aids

Hearing aid fitting and usage

Device: Hearing aids

Interventions

Hearing aidsDEVICE

Fitting of hearing aids (for the first time)

First time users of hearing aids

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

18 years and older patients using hearing aids for the first time

You may qualify if:

  • Hebrew speaking
  • First time users of hearing aids

You may not qualify if:

  • Using a wheelchair
  • Neurological disorders
  • Spine of leg surgery in the previous 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

DizzinessHearing Loss

Interventions

Hearing Aids

Condition Hierarchy (Ancestors)

Sensation DisordersNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsHearing DisordersEar DiseasesOtorhinolaryngologic DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Wearable Electronic DevicesElectrical Equipment and SuppliesEquipment and SuppliesSensory Aids

Central Study Contacts

Yahav Oron, MD

CONTACT

972-3-5772450orony@clalit.org.il

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 2, 2019

First Posted

June 4, 2019

Study Start

September 1, 2019

Primary Completion

May 30, 2020

Study Completion

May 30, 2020

Last Updated

July 30, 2019

Record last verified: 2019-05

Data Sharing

IPD Sharing
Will not share