NCT01897181

Brief Summary

The purpose of this study is to evaluate the central auditory processing in patients with bilateral sensorineural hearing loss and to observe the change of the central auditory processing ability after using hearing aids.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
27

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

July 1, 2013

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

July 5, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 11, 2013

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

February 17, 2016

Status Verified

February 1, 2016

Enrollment Period

2.4 years

First QC Date

July 5, 2013

Last Update Submit

February 14, 2016

Conditions

Auditory Processing Disorder, Central

Keywords

Central auditory processingBilateral sensorineural hearing lossHearing aids

Outcome Measures

Primary Outcomes (1)

  • Change from the baseline in the Hearing In Noise Test (HINT) score at 6 months

    HINT measures a person's ability to hear speech in quiet and in noise. In the test, the patient is required to repeat sentences both in a quiet environment and with competing noise being presented from different directions.

    at screening and 6 months after starting hearing aids use

Secondary Outcomes (2)

  • changes from the baseline in central auditory processing disorder test score at 1, 3, 6, 9 and 12 months

    at screening, 1, 3, 6, 9, and 12 months after starting hearing aids use

  • changes from the baseline in the HINT score at 3, 9, and 12 months

    baseline, 3, 9 and 12 months

Study Arms (2)

Hearing aids

ACTIVE COMPARATOR

Patients who agree to use hearing aids

Device: Hearing aids

No hearing aids

NO INTERVENTION

Patients who did not agree to use hearing aids

Interventions

Hearing aidsDEVICE

Using hearing aids for 12 months

Hearing aids

Eligibility Criteria

Age45 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults of age 45 years of older
  • Bilateral sensorineural hearing loss
  • Average pure tone audiometry threshold \>= 40dB
  • Speech discrimination \>= 60% in both ears

You may not qualify if:

  • Refusing the study
  • Medical history of any brain damage or intracranial surgery
  • Showing signs of central lesion in MRI or neurologic exams
  • Speech discrimination \< 60% in any ear

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asan Medical Center

Seoul, 138-736, South Korea

Location

MeSH Terms

Conditions

Language Development Disorders

Interventions

Hearing Aids

Condition Hierarchy (Ancestors)

Language DisordersCommunication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Wearable Electronic DevicesElectrical Equipment and SuppliesEquipment and SuppliesSensory Aids

Study Officials

  • Jong Woo Chung, MD

    Asan Medical Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

July 5, 2013

First Posted

July 11, 2013

Study Start

July 1, 2013

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

February 17, 2016

Record last verified: 2016-02

Locations

KR(1)