Evaluering av fleksible ledende høreapparater
En ikke-invasiv, fleksibel ledende høreapparat med mikroepidermale aktuatorer for barn og voksne pasienter
Conductive hearing loss (CHL) is the most common type of hearing loss among the pediatric population. CHL occurs when sound is not properly transmitted from the external ear to the cochlea, and congenital pathologies like microtia/anotia, atresia, and absent or malformed ossicles make hearing loss permanent.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Standard treatment for permanent conductive hearing loss includes osseointegrated implants, which require surgery and are invasive for pediatric patients. Conductive hearing loss can also be treated by non-surgical solutions such as wearable and behind-the-ear aids; however, they present challenges such as instability, stigmatization, and discomfort because of the device's design. Therefore, patients (ages 6 months to 80 years) with permanent (CHL) can benefit from a flexible, Band-Aid like hearing aid.
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Mohammad Moghimi, PhD
- Telefonnummer: (336) 713-2113
- E-post: Seyyed.moghimi@wfusm.edu
Studer Kontakt Backup
- Navn: Enosh Lim, MS
- Telefonnummer: 704-355-2000
- E-post: Enosh.Lim@wfusm.edu
Studiesteder
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-
North Carolina
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Winston-Salem, North Carolina, Forente stater, 27157
- Rekruttering
- Wake Forest University Health Sciences
-
Ta kontakt med:
- Enosh Lim, MS
- Telefonnummer: 704-355-2000
- E-post: Enosh.Lim@wfusm.edu
-
Ta kontakt med:
- Mohammad Moghimi, PhD
- Telefonnummer: 336-713-2113
- E-post: Seyyed.moghimi@wfusm.edu
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Male and female infants, children, adolescents, and adult patients who are diagnosed with unilateral or bilateral mixed or conductive hearing loss
- Male and female patients seen at Atrium Health-Audiology for a clinical, standard of care office visit who have a diagnosis of conductive or mixed hearing loss and may currently wear hearing aids
- Male and female infants, children, adolescents, and adults who are candidates for conductive hearing aids (Osseo-integrated or wearable aids) or for canalplasty or ossicular chain reconstruction surgery
- Healthy subjects will include male and female infants, children, adolescents, and adults who do not have conductive or mixed hearing loss
- Pregnant women -are eligible for this study. Standard of Care allows pregnant patients to be fit for hearing aids without risk.
Exclusion Criteria:
- Adult patients unable to independently understand the purpose of the study and the procedures and/or who are not willing to participate
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Grunnvitenskap
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: flexible Band-Aid style hearing device
Patients with conductive/mixed hearing loss will be assessed to observe their hearing threshold before using the hearing aid and reassessed with our hearing aid attached. Healthy subjects will wear noise-cancelling headphones and ear plugs to simulate conductive hearing loss, and their hearing threshold will be assessed before and during the flexible hearing aid attachment. |
Eligible patients will wear hearing aids on flexible substrate and MEA (Micro epidermal actuator is a flexible material (e.g., plastics) to be placed on epidermis layer of skin for generating vibrations) on skull behind the ear or forehead. A neonatal adhesive, tape, Band-Aid or a headband will secure the aid/MEA on the skin. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Does the subject indicate hearing or states they can hear sound
Tidsramme: Hour 1
|
Voltage (with a maximum of 20 V, frequency range: 20 Hz to 20 kHz) will be applied to Micro epidermal actuator (MEA) through external power supply/function generator, or through amplifier in the hearing aid circuit. While wearing the device, they are asked to respond or repeat when they hear sound either delivered through the device or through the speaker on the wall in front of them. All sounds are presented at a comfortable level. |
Hour 1
|
Samarbeidspartnere og etterforskere
Etterforskere
- Hovedetterforsker: Mohammad Moghimi, PhD, Wake Forest University Health Sciences
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- IRB00133858
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
All of the individual participants data, collected during the trial after deidentification
IPD-delingstidsramme
Immediately after publication. No end date
Tilgangskriterier for IPD-deling
Any purposes
IPD-deling Støtteinformasjonstype
- STUDY_PROTOCOL
Legemiddel- og utstyrsinformasjon, studiedokumenter
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