Hearing Loss, BilateralPhase 1/2P02NCT01902914
Effectiveness of P02 Digital Hearing Aids
A Phase 1/2 study testing Hearing Aids Evaluation in people with Hearing Loss, Bilateral and Sensorineural Hearing Loss, run by Khon Kaen University at 1 site in Thailand.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 to 90 years
- Conditions the study is for
- Hearing Loss, Bilateral, Sensorineural Hearing Loss
- What is being tested?
- Hearing Aids Evaluation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteThailand
- Study dates
- Oct 2012to Sep 2014
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- speech discrimination <40%
- suspected of retrocochlear lesion
Trial locations and contacts
1 site in 1 country.
Thailand1 site, 1 recruiting
- Recruiting
Phu Wieng district
Khon Kaen, Changwat Khon Kaen
Kwanchanok Yimtae, MD, 6643348396, kwayim@kku.ac.th
Kwanchanok Yimtae, MD
About this study
Official title: Effectiveness of NECTEC Model, Body-worn, Digital Hearing Aids and Cost of Screening and Hearing Aids Service in Elders
To test the effectiveness of body-worn, digital hearing aids, model 02 which is developed by the National Electronics and Computer Technology Center, Thailand.
Read the detailed description
Hearing aids distribution and service system are limited accessed in hearing disabled people in developing countries. The local-made, body-worn, digital hearing aids is developed by the National Electronics and Computer Technology Center, Thailand. The effectiveness of this model will be compares with other standard body-worn, hearing aids in community elders. The functional gain, quality of sound, customers' satisfaction, and quality of life (EQ-5D, HHIE, HUI-3, IOI-HA) are main outcomes.The cost of Screening and hearing aids will be also investigated. The validity and reliability of several tools used such as the Thai-Hearing Handicap Inventory for elderly (HHIE) questionnaire, Music Test, Thai-Five Minute Hearing Test, and Khon Kaen Hearing Aids Evaluation are also studied.
- Being tested
- Hearing Aids Evaluation
- Keywords
- hearing aids, hearing disability, community, hearing aids service
- Medical subject headings
- Hearing Loss, Bilateral, Hearing Loss, Sensorineural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hearing Aids EvaluationProcedure or surgery
Also called Functional Gain
Functional Gain Sound field Speech Audiometry
| Study group | Role | What they receive |
|---|---|---|
| Hearing Aids, Model P02 | Experimental | A body-worn, local made, digital hearing aids Hearing Aids evaluation Receives: Procedure: Hearing Aids Evaluation |
| Other hearing aids | Active comparator | Other Hearing Aids, Hearing Aids Evaluation Receives: Procedure: Hearing Aids Evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
functional gain
Different of hearing threshold between aids and un-aids
Measured: Immediate after hearing aids fitting
Secondary outcomes (1)
Satisfaction
Sound quality satisfaction
Measured: immediate after hearing aids fitting
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2013 (estimated)
- Study startOct 2012
- Primary completionSep 2014 (estimated)
- Study completionSep 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hearing Loss, BilateralStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Khon Kaen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kwanchanok Yimtae, M.D., Khon Kaen University
- Investigators
- Kwanchanok Yimtae, MD, Principal investigator, Khon Kaen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01902914
- Sponsor's protocol ID
- HE551268
- Acronym
- P02
- Status last verified
- Apr 2014
- First submitted
- 1 Oct 2012
- Last updated
- 21 Apr 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 34301203
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of NECTEC Model, Body-worn, Digital Hearing Aids and Cost of Screening and Hearing Aids Service in Elders
- ClinicalTrials.gov ID
- NCT01902914
- Acronym / sponsor ID
- P02 / HE551268
- Keywords
- hearing aids, hearing disability, community, hearing aids service
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Khon Kaen UniversityUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Sep 2014 (estimated)
- Study completion
- Sep 2014 (estimated)
- First posted
- 18 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To test the effectiveness of body-worn, digital hearing aids, model 02 which is developed by the National Electronics and Computer Technology Center, Thailand.
Detailed description
Hearing aids distribution and service system are limited accessed in hearing disabled people in developing countries. The local-made, body-worn, digital hearing aids is developed by the National Electronics and Computer Technology Center, Thailand. The effectiveness of this model will be compares with other standard body-worn, hearing aids in community elders. The functional gain, quality of sound, customers' satisfaction, and quality of life (EQ-5D, HHIE, HUI-3, IOI-HA) are main outcomes.The cost of Screening and hearing aids will be also investigated. The validity and reliability of several tools used such as the Thai-Hearing Handicap Inventory for elderly (HHIE) questionnaire, Music Test, Thai-Five Minute Hearing Test, and Khon Kaen Hearing Aids Evaluation are also studied.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hearing Aids, Model P02 | Experimental | Procedure: Hearing Aids EvaluationA body-worn, local made, digital hearing aids Hearing Aids evaluation |
| Other hearing aids | Active comparator | Procedure: Hearing Aids EvaluationOther Hearing Aids, Hearing Aids Evaluation |
Who may qualify
- Ages
- 60 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- speech discrimination <40%
- suspected of retrocochlear lesion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hearing Aids EvaluationAlso: Functional GainFunctional Gain Sound field Speech Audiometry | Procedure or surgery | Hearing Aids, Model P02, Other hearing aids |
Primary outcome
functional gain
Time frame: Immediate after hearing aids fitting
Different of hearing threshold between aids and un-aids
1 secondary outcome
Satisfaction
Time frame: immediate after hearing aids fitting
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2014.
- Derived from this study: PubMed 34301203Kasemsiri 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kwanchanok Yimtae, MD principal investigator
Khon Kaen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Hearing Aids Evaluation in people with Hearing Loss, Bilateral and Sensorineural Hearing Loss, run by Khon Kaen University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
functional gain (time frame: Immediate after hearing aids fitting). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01902914, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2014.