Development of a Mobile App FFVT vs FFCT : A RCT
Development of a Mobile-app Based Free Field Click Test Against Conventional Free Field Voice Test
1 other identifier
interventional
50
1 country
1
Brief Summary
This is an open-labelled randomised controlled trial involving 2 groups which are Free Field voice test vs Free Field Click tests using digital hand-held devices. This study will be done at a sound-proof room in ORL clinic in Hospital Sultanah Aminah, Johor, Malaysia from January till July 2020.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2020
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2020
CompletedFirst Submitted
Initial submission to the registry
January 22, 2020
CompletedFirst Posted
Study publicly available on registry
January 27, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2020
CompletedSeptember 1, 2020
August 1, 2020
6 months
January 22, 2020
August 31, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Subjective hearing threshold
To compare the sensitivity and specificity of FFVT and FFCT, the study end-point involves the subjective hearing threshold obtained from the patient upon hearing the tested sound and comparing results to Pure Tone Audiogram and obtaining the Pure Tone Average
15 minutes
Secondary Outcomes (4)
Gender comparison
15 minutes
Age Comparison
15 minutes
Tympanogram comparison
15 minutes
Laterality comparison
15 minutes
Study Arms (2)
Free Field Voice test
ACTIVE COMPARATORThe examiner will inform the patient to repeat a sequence of Spondee words or a combination of numbers and letters whispered by the examiner initially. The examiner will be standing at the same distances as in the FFCT examination (starting with 2 feet). If the patient fails to hear the whispered voice at 2 feet, the examiner increases the loudness of voice to conversational tone at the same distance. The test is repeated thrice each time with a different set of Spondee words to avoid the patients recognizing the same sequence. If the patient is unable to respond, the examiner moves closer to 6 inches and whispers to the patient, and if no further response, then, conversational voice is used. The patient's free-field threshold is the voice and distance level at which more than 50% correct is obtained.
Free Field Click Test
EXPERIMENTALThe app is designed by our team by a broadband (500-3000 Hz) click sound of 30-40 dB for soft sound/whisper and 60-70dB for loud sound/conversation voice. This app is designed by the Flutter-Dart programming tool and the speaker is produced via hand-held devices of Apple and Android brands. The tone is produced 3 times, with 2 out of 3 answers are considered as the patient's hearing threshold. The examiner stands at the distance of 2 feet away behind the seated patient and a soft sound from the FFCT is tested. The patient is then asked to respond yes or to nod if able to hear the sound. When the patient is unable to answer or no response is received upon thrice testing, the examiner then moves closer to 6 inches to the patient and again the soft sound is tested thrice. Loud sound is then tested if the patient is unable to respond, starting from 2 feet distance for three times. And then, the loud sound is tested at 6 inches of distance if no further response is obtained.
Interventions
A Pure Tone Audiogram is done in a sound proof room in both cases of Free Field Voice Test and Free Field Click Tests to identify the Pure Tone Average (Hearing Threshold Average of 500Hz,1000Hz and 2000Hz).
Eligibility Criteria
You may qualify if:
- i) Age 18-80 years old ii) Chief complaint of reduced hearing -unilaterally or bilaterally iii) Able to communicate with the examiners iv) Post-traumatic patients with uni/bilateral hearing loss
You may not qualify if:
- i) Age \< 18 or \> 80 years old ii) Uncooperative patient iii) Not consented iv) Intellectually-challenged v) Pregnant ladies vi) Previous ear surgery/ear tumor
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital Sultanah Aminah Johor Bahru
Johor Bahru, Johor, 80000, Malaysia
Related Publications (3)
Pirozzo S, Papinczak T, Glasziou P. Whispered voice test for screening for hearing impairment in adults and children: systematic review. BMJ. 2003 Oct 25;327(7421):967. doi: 10.1136/bmj.327.7421.967.
PMID: 14576249RESULTDempster JH, Mackenzie K. Clinical role of free-field voice tests in children. Clin Otolaryngol Allied Sci. 1992 Feb;17(1):54-6. doi: 10.1111/j.1365-2273.1992.tb00988.x.
PMID: 1555319RESULTMcShefferty D, Whitmer WM, Swan IR, Akeroyd MA. The effect of experience on the sensitivity and specificity of the whispered voice test: a diagnostic accuracy study. BMJ Open. 2013 Apr 18;3(4):e002394. doi: 10.1136/bmjopen-2012-002394. Print 2013.
PMID: 23604349RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Goh Liang Chye, MS (ORL-HNS)
Otorhinolaryngologist
- PRINCIPAL INVESTIGATOR
Thilaga Rajendren, MBBS
Medical officer
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
January 22, 2020
First Posted
January 27, 2020
Study Start
January 1, 2020
Primary Completion
July 1, 2020
Study Completion
July 1, 2020
Last Updated
September 1, 2020
Record last verified: 2020-08
Data Sharing
- IPD Sharing
- Will not share
There is not a plan to make IPD available.