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New treatment option for Sensorineural Hearing Loss
Official title Cochlear Implanted Listening Effort and Hearing Attention
ClinicalTrials.gov ID: NCT04733950
What this study is testing
- What it's testing
- Cochlear implant users perceive mainly sound amplitude modulation cues. Processing of these amplitude modulations can be subject to interferences, so that the perception of a modulation in a target sound can be impaired by a superimposed sound if this sound contains a similar modulation.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80. Healthy volunteers may be eligible.
You may be able to join if
- Arm 1: patient with Cochlear Implant
- Having a unilateral Oticon Medical cochlear implant
- Duration of use of the implant of 6 months or more
- Disyllabic word recognition score of at least 40% on average in silence, to limit "floor" effects in hearing tests.
- Disyllabic word recognition score not exceeding 30% on the contra-lateral ear alone, aided or not, in silence. Arm 2: volunteers with normal hearing...
You likely can't join if
- For both groups, ensuring the reliability of the pupillometric measurement (Winn et al., 2018):
- Pathologies of the eye: cataracts, nystagmus, amblyopia, macular degeneration.
- Taking psychotropic drugs and / or drugs affecting the parasympathetic nervous system
- Neurological pathology (in particular head trauma or stroke) associated with an alteration of cognitive functions or history thereof that may affect...
- No affiliation (or being entitled) to a social security scheme
- Person under State Medical Assistance
See the full eligibility criteria
- Arm 1: patient with Cochlear Implant
- Having a unilateral Oticon Medical cochlear implant
- Duration of use of the implant of 6 months or more
- Disyllabic word recognition score of at least 40% on average in silence, to limit "floor" effects in hearing tests.
- Disyllabic word recognition score not exceeding 30% on the contra-lateral ear alone, aided or not, in silence. Arm 2: volunteers with normal hearing \- Normal tonal audiometry for the age For both
- Age between 18 and 80 years old
- Mother tongue : French
- Normal vision with or without correction
- Absence of eye pathologies (cataracts, nystagmus, amblyopia, macular degeneration).
- Not taking psychotropic drugs or drugs affecting the parasympathetic nervous system
- Absence of pathology or neurological history (especially head trauma, stroke).
- Information and signing of a consent prior to any act related to research
- For both groups, ensuring the reliability of the pupillometric measurement (Winn et al., 2018):
- Pathologies of the eye: cataracts, nystagmus, amblyopia, macular degeneration.
- Taking psychotropic drugs and / or drugs affecting the parasympathetic nervous system
- Neurological pathology (in particular head trauma or stroke) associated with an alteration of cognitive functions or history thereof that may affect the stability of the gaze, the congruence of eye movements, pupillary...
- No affiliation (or being entitled) to a social security scheme
- Person under State Medical Assistance
- Person under legal protection (tutorship, curatorship, other…) or under family authorization
The study team makes the final eligibility decision.
Where it's taking place
- Paris, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Paris, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.