Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06635642
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-08
Brief Title:
Auditory Research in Children Living With HIV Exposure-uninfected ARCHIVE
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Auditory Research in Children Living With HIV Exposure-uninfected ARCHIVE
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ARCHIVE
Brief Summary:
To evaluate the association of in utero antiretroviral therapy ART exposure and hearing abilities of children who were perinatally HIV-exposed but HIV-free stratified by timing of maternal ART initiation
Detailed Description:
This is a non-randomized cross-sectional study of 7-10-year-old children that will also include an observational pre-post clinical trial for those children who will require intervention Childrenparent pairs will be contacted during their 7-year-old visit as part of the Healthy Child Study HCS Collaborators include investigators from the HCS trial They will assist in the recruitment and data sharing of children with perinatally exposed to HIV but HIV-free PHEF and children HIV-unexposed and HIV-free HUF from the HCS All personnel conducting the assessments will be blinded to the childs HIV exposure status All peripheral measures of hearing ie otoscopy tympanometry distortion product otoacoustic emissions DPOAEs and pure-tone audiometry are routinely performed in clinic Central auditory processing measures ie dichotic digits testing DDT and speech recognition in noise are not part of routine audiological evaluation but will not require any additional training since these measures are within the scope of work for pediatric clinical audiologists
Audiological Evaluation The hearing examination consists of questionnaire otoscopy tympanometry pure-tone air-conduction and bone-conduction audiometry speech recognition thresholds SRTs speech recognition in noise DDT and DPOAEs Questionnaires otoscopy and tympanometry can be completed in clinic rooms but pure-tone audiometry SRTs DDT speech recognition in noise and DPOAEs will be completed in sound treated rooms The hearing examination portion will take 60 minutes and children will be given breaks when needed A detailed explanation of the procedures is outlined below
Questionnaire The detailed hearing-related health questionnaire will be administered to all participants Questions will include whether the child had a newborn hearing screening test and if so these data will be extracted from medical records to determine if they passed or failed history of middle ear involvement trauma to the ears or head family history of hearing loss and any other medical-related hearing history mothercaregiver-perception of any hearing problems noise exposure and any previous hearing aid use The demographic questions will include date of birth sex race primary language spoken educational level of the child childs performance at school caregivers education level occupational status annual income and family history of hearing loss
Otoscopy and Tympanometry In a designated clinic room within the Speech Therapy Audiology Clinic at Tygerberg Hospital an audiologist will perform an otoscopic evaluation on each ear of the child Information about the presence of debris eg cerumen in the external ear canal color and position of the eardrum and presenceabsence of a perforation will be noted Tympanometry will then be performed by the audiologists This provides information regarding the functioning of the tympanic membrane The tympanogram will be a critical component to this proposal because these measures will most likely identify otitis media in children and poor middle ear function will have a negative but temporary effect on DPOAEs If there is an active middle ear involvement based on otoscopy and tympanometry measures testing will be discontinued the child will be referred to the Ear Nose and Throat ENT clinic within Tygerberg Hospital and the child will be rescheduled for testing once the fluidinfection has been resolved and tympanometry is within normal limits
Pure-tone Hearing Testing An audiologist will perform all pure-tone audiometric testing using traditional assessment protocols Pure-tone audiometry using supra-aural earphones will be completed Testing will be conducted in a sound-treated booth on calibrated equipment Air conduction AC thresholds will be obtained at octave frequencies from 025-8 kHz bilaterally Masking will be used when appropriate If AC thresholds are 15 decibels of hearing level dB HL a bone conduction BC transducer will be placed on the mastoid of the poorer ear as determined by the air-conduction thresholds BC thresholds will be determined at 05-4 kHz If air bone gaps are noted masking to obtain BC thresholds will be used at all frequencies with an air-bone gap 15 dB HL
Distortion Product Otoacoustic Emissions DPOAEs will be used to assess integrity of cochlear outer hair cell function DPOAEs will be measured using two primary frequencies f1 and f2 where f2 f1 at f2f1 122 f2 swept from 1 through 8 kHz and a f1 level L1 of 65 dB of sound pressure level SPL and a f2 level L2 of 55 dB SPL The child will be instructed to remain as quiet as possible and that they do not need to respond
Speech Recognition Thresholds SRT data will be obtained under earphones once pure-tone testing has been completed The South African Spondaic wordlist will be presented in English and the lowest dB HL level that the child can repeat words 50 correctly will establish the SRT for each ear Speech recognition in noise testing will then be completed Presentation level of words will be determined as 50 dB above the SRT for each ear For example if the SRT for the right ear was 15 dB HL then the fixed presentation level for that ear during speech recognition in noise would be 65 dB HL This ensures a comfortable listening level well above the childs hearing thresholds The background noise will be set 8 dB HL below the presentation level of the words And in the example above the background noise would be set to 57 dB HL This is a more complex listening setting but not too difficult for the children to be able to repeat the words that they hear
Dichotic Digits Testing DDT will be completed in order to evaluate binaural integration Testing will be completed under earphones once the SRT has been established The test will be presented at 50 dB above the SRT consistent with speech recognition in noise to ensure a comfortable listening level The child will be instructed that they will hear two numbers in each ear simultaneously and to listen carefully in both ears and repeat all of the numbers they hear The repeated order will not matter and guessing the numbers is acceptable The child will be given practice items before scoring begins The test will consist of 20 stimulus presentations or 80 total digits 40 per ear Numbers between 1-10 with the exception of 7 due to not being monosyllabic will be presented in a random order Scoring for each ear will be calculated as percent correct for each ear
Intervention Children who meet the criterion for DDT deficit 15 difference between the ears will be scheduled for 12 Dichotic Interaural Intensity Difference DIID training sessions 20-30 minutes each over a 4-6 week period Training will take place in the afternoon at the FAMCRU satellite research unit in Khayelitsha Michael Mapongwana Hospital which is close to participants homes Training will be administered using a custom iPad application routed through earphones within a quiet room at FAMCRU satellite research unit Training will focus on the poorer ear as reflected on DDT scores The training stimuli are a combination of English digits or consonant-vowel-consonant CVC words recorded by a male talker The dichotic listening tasks focused on binaural integration only Prior to starting the DIID training the childs crossover point will be established The crossover point is the interaural intensity difference IID during a dichotic task at which performance in the poorer ear exceeds the better ear The IID is created when the intensity level of the stimulus in the better ear is decreased while maintaining a constant intensity level in the poorer ear Training will begin at 50 dB above the SRT in the poorer ear based on the DDT scores and at 5 dB above the crossover point for the better ear based on the DDT scores
A total of five trials will be presented in a sequence and there will be 10 sequences per training session Each of the 25 CVC words or digits 1 through 10 excluding 7 will be presented to each ear during the session The pairs will be randomized every time and a word will never be paired with itself After a sequence is completed the difficulty of the task will be adjusted in real time based on performance on the prior task If the child scored 4 or 5 of 5 correct in the poorer ear then the IID will be decreased by 2 dB making the task more difficult If the child scores 0 1 or 2 of 5 correct then the IID will be increased by 2 dB making the task easier Last if the child scores 3 of 5 correct then the IID will remain unchanged for the next sequence
One month following completion of DIID training the child will be scheduled for both DDT and speech recognition in noise testing at the Division of Speech-Language and Hearing Therapy at Tygerberg Hospital
Audiological Evaluation The hearing examination consists of questionnaire otoscopy tympanometry pure-tone air-conduction and bone-conduction audiometry speech recognition thresholds SRTs speech recognition in noise DDT and DPOAEs Questionnaires otoscopy and tympanometry can be completed in clinic rooms but pure-tone audiometry SRTs DDT speech recognition in noise and DPOAEs will be completed in sound treated rooms The hearing examination portion will take 60 minutes and children will be given breaks when needed A detailed explanation of the procedures is outlined below
Questionnaire The detailed hearing-related health questionnaire will be administered to all participants Questions will include whether the child had a newborn hearing screening test and if so these data will be extracted from medical records to determine if they passed or failed history of middle ear involvement trauma to the ears or head family history of hearing loss and any other medical-related hearing history mothercaregiver-perception of any hearing problems noise exposure and any previous hearing aid use The demographic questions will include date of birth sex race primary language spoken educational level of the child childs performance at school caregivers education level occupational status annual income and family history of hearing loss
Otoscopy and Tympanometry In a designated clinic room within the Speech Therapy Audiology Clinic at Tygerberg Hospital an audiologist will perform an otoscopic evaluation on each ear of the child Information about the presence of debris eg cerumen in the external ear canal color and position of the eardrum and presenceabsence of a perforation will be noted Tympanometry will then be performed by the audiologists This provides information regarding the functioning of the tympanic membrane The tympanogram will be a critical component to this proposal because these measures will most likely identify otitis media in children and poor middle ear function will have a negative but temporary effect on DPOAEs If there is an active middle ear involvement based on otoscopy and tympanometry measures testing will be discontinued the child will be referred to the Ear Nose and Throat ENT clinic within Tygerberg Hospital and the child will be rescheduled for testing once the fluidinfection has been resolved and tympanometry is within normal limits
Pure-tone Hearing Testing An audiologist will perform all pure-tone audiometric testing using traditional assessment protocols Pure-tone audiometry using supra-aural earphones will be completed Testing will be conducted in a sound-treated booth on calibrated equipment Air conduction AC thresholds will be obtained at octave frequencies from 025-8 kHz bilaterally Masking will be used when appropriate If AC thresholds are 15 decibels of hearing level dB HL a bone conduction BC transducer will be placed on the mastoid of the poorer ear as determined by the air-conduction thresholds BC thresholds will be determined at 05-4 kHz If air bone gaps are noted masking to obtain BC thresholds will be used at all frequencies with an air-bone gap 15 dB HL
Distortion Product Otoacoustic Emissions DPOAEs will be used to assess integrity of cochlear outer hair cell function DPOAEs will be measured using two primary frequencies f1 and f2 where f2 f1 at f2f1 122 f2 swept from 1 through 8 kHz and a f1 level L1 of 65 dB of sound pressure level SPL and a f2 level L2 of 55 dB SPL The child will be instructed to remain as quiet as possible and that they do not need to respond
Speech Recognition Thresholds SRT data will be obtained under earphones once pure-tone testing has been completed The South African Spondaic wordlist will be presented in English and the lowest dB HL level that the child can repeat words 50 correctly will establish the SRT for each ear Speech recognition in noise testing will then be completed Presentation level of words will be determined as 50 dB above the SRT for each ear For example if the SRT for the right ear was 15 dB HL then the fixed presentation level for that ear during speech recognition in noise would be 65 dB HL This ensures a comfortable listening level well above the childs hearing thresholds The background noise will be set 8 dB HL below the presentation level of the words And in the example above the background noise would be set to 57 dB HL This is a more complex listening setting but not too difficult for the children to be able to repeat the words that they hear
Dichotic Digits Testing DDT will be completed in order to evaluate binaural integration Testing will be completed under earphones once the SRT has been established The test will be presented at 50 dB above the SRT consistent with speech recognition in noise to ensure a comfortable listening level The child will be instructed that they will hear two numbers in each ear simultaneously and to listen carefully in both ears and repeat all of the numbers they hear The repeated order will not matter and guessing the numbers is acceptable The child will be given practice items before scoring begins The test will consist of 20 stimulus presentations or 80 total digits 40 per ear Numbers between 1-10 with the exception of 7 due to not being monosyllabic will be presented in a random order Scoring for each ear will be calculated as percent correct for each ear
Intervention Children who meet the criterion for DDT deficit 15 difference between the ears will be scheduled for 12 Dichotic Interaural Intensity Difference DIID training sessions 20-30 minutes each over a 4-6 week period Training will take place in the afternoon at the FAMCRU satellite research unit in Khayelitsha Michael Mapongwana Hospital which is close to participants homes Training will be administered using a custom iPad application routed through earphones within a quiet room at FAMCRU satellite research unit Training will focus on the poorer ear as reflected on DDT scores The training stimuli are a combination of English digits or consonant-vowel-consonant CVC words recorded by a male talker The dichotic listening tasks focused on binaural integration only Prior to starting the DIID training the childs crossover point will be established The crossover point is the interaural intensity difference IID during a dichotic task at which performance in the poorer ear exceeds the better ear The IID is created when the intensity level of the stimulus in the better ear is decreased while maintaining a constant intensity level in the poorer ear Training will begin at 50 dB above the SRT in the poorer ear based on the DDT scores and at 5 dB above the crossover point for the better ear based on the DDT scores
A total of five trials will be presented in a sequence and there will be 10 sequences per training session Each of the 25 CVC words or digits 1 through 10 excluding 7 will be presented to each ear during the session The pairs will be randomized every time and a word will never be paired with itself After a sequence is completed the difficulty of the task will be adjusted in real time based on performance on the prior task If the child scored 4 or 5 of 5 correct in the poorer ear then the IID will be decreased by 2 dB making the task more difficult If the child scores 0 1 or 2 of 5 correct then the IID will be increased by 2 dB making the task easier Last if the child scores 3 of 5 correct then the IID will remain unchanged for the next sequence
One month following completion of DIID training the child will be scheduled for both DDT and speech recognition in noise testing at the Division of Speech-Language and Hearing Therapy at Tygerberg Hospital
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None