NCT01902914

Brief Summary

To test the effectiveness of body-worn, digital hearing aids, model 02 which is developed by the National Electronics and Computer Technology Center, Thailand.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Oct 2012

Geographic Reach
1 country

1 active site

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

October 1, 2012

Completed
Same day until next milestone

Study Start

First participant enrolled

October 1, 2012

Completed
10 months until next milestone

First Posted

Study publicly available on registry

July 18, 2013

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

April 21, 2014

Status Verified

April 1, 2014

Enrollment Period

1.9 years

First QC Date

October 1, 2012

Last Update Submit

April 17, 2014

Conditions

Hearing Loss, BilateralSensorineural Hearing Loss

Keywords

hearing aidshearing disabilitycommunityhearing aids service

Outcome Measures

Primary Outcomes (1)

  • functional gain

    Different of hearing threshold between aids and un-aids

    Immediate after hearing aids fitting

Secondary Outcomes (1)

  • Satisfaction

    immediate after hearing aids fitting

Study Arms (2)

Hearing Aids, Model P02

EXPERIMENTAL

A body-worn, local made, digital hearing aids Hearing Aids evaluation

Procedure: Hearing Aids Evaluation

Other hearing aids

ACTIVE COMPARATOR

Other Hearing Aids, Hearing Aids Evaluation

Procedure: Hearing Aids Evaluation

Interventions

Hearing Aids EvaluationPROCEDURE

Functional Gain Sound field Speech Audiometry

Also known as: Functional Gain
Hearing Aids, Model P02Other hearing aids

Eligibility Criteria

Age60 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • older than 60 years
  • bilateral sensorineural hearing loss
  • PTA (0.5-2 KHz) of better ear \> 40 DB but \<75 dB
  • no deformity of pinna and ear canal
  • new or unexperienced hearing aids user
  • can communicate with Thai or local language

You may not qualify if:

  • speech discrimination \<40%
  • suspected of retrocochlear lesion

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Phu Wieng district

Khon Kaen, Changwat Khon Kaen, Thailand

RECRUITING

Related Publications (1)

  • Kasemsiri P, Yimtae K, Thanawirattananit P, Israsena P, Noymai A, Laohasiriwong S, Vatanasapt P, Siripaopradith P, Kingkaew P. Effectiveness of a programable body-worn digital hearing aid for older adults in a developing country: a randomized controlled trial with a cross-over design. BMC Geriatr. 2021 Jul 23;21(1):437. doi: 10.1186/s12877-021-02325-4.

    PMID: 34301203DERIVED

MeSH Terms

Conditions

Hearing Loss, BilateralHearing Loss, Sensorineural

Condition Hierarchy (Ancestors)

Hearing LossHearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Kwanchanok Yimtae, MD

    Khon Kaen University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. Prof. Kwanchanok Yimtae

Study Record Dates

First Submitted

October 1, 2012

First Posted

July 18, 2013

Study Start

October 1, 2012

Primary Completion

September 1, 2014

Study Completion

September 1, 2014

Last Updated

April 21, 2014

Record last verified: 2014-04

Locations

TH(1)