Dizziness Among First Time Users of Hearing Aids | NCT03973658

Studies
Dizziness Among First Time Users of Hearing Aids

NCT03973658

Sponsor

Clalit Health Services

Status

Unknown status

Last Update Posted

Jul 30, 2019Actual

Enrollment

60Estimated

Phase

Not provided

Conditions

Dizziness
Hearing Loss

Interventions

Hearing aids

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1, 2019Estimated

Primary Completion Date

May 30, 2020Estimated

Completion Date

May 30, 2020Estimated

First Submitted Date

Jun 2, 2019

First Submission Date that Met QC Criteria

Jun 2, 2019

First Posted Date

Jun 4, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 29, 2019

Last Update Posted Date

Jul 30, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
First time users of hearing aids		Hearing aid fitting and usage	Device: Hearing aids

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Hearing aids	Device	Fitting of hearing aids (for the first time)	First time users of hearing aids

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Usage of hearing aids	The duration the participants used the hearing aids	2 months

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Yahav Oron, MD	Contact	972-3-5772450		orony@clalit.org.il

Overall Officials

Not provided

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D004244	Dizziness
D034381	Hearing Loss

Ancestor Terms

ID	Term
D012678	Sensation Disorders
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D006310	Hearing Aids

Ancestor Terms

ID	Term
D000076251	Wearable Electronic Devices
D055615	Electrical Equipment and Supplies
D004864	Equipment and Supplies
D012682	Sensory Aids

Browse Leaves

Not provided

Browse Branches

Not provided