FIPPI-CI

Overview
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The indications for a cochlear implant (CI) have been extended to include patients with some residual hearing. However, insertion of the electrode array into the cochlea with potential mechanical trauma due to the presence of this foreign body in the cochlea can lead to the formation of free radicals and reduced blood flow to the cochlea, resulting in loss of residual hearing. In this randomized, placebo-controlled, double-blind clinical trial, the effect of radical scavengers and a vasodilator on residual hearing is investigated. The food supplement consists of β-carotene (vitamin A), ascorbic acid (vitamin C), dl-α-tocopherol acetate (vitamin E) and the vasodilating magnesium (Mg), ACEMg for short. The primary measure is based on the reduction of postoperative low frequency air conduction pure tone thresholds compared to the preoperative thresholds in ACEMg treated patients compared to those of a placebo group.

SEEK ID: https://ldh.zks-mhh.imise.uni-leipzig.de/projects/1

Public web page: Not specified

NFDI4Health PALs: No PALs for this Project

Project start date: 15th Jun 2020

Project end date: 28th Apr 2025

Extended Metadata (Nfdi4Health MDS 3.3)

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Id of the project(*) : nfdi4health-29968

Resource classification(*)

Type of the resource : Study

Title(s)/name(s) of the Project

Title/name : Food supplement induced residual hearing preservation in partial insertion - cochlear implantation
Language of the title/name : English

Acronym(s) of the Project

Acronym : FIPPI-CI
Language of the acronym : English

Description(s) of the Project

Description : Die Indikationen für ein Cochlea-Implantat (CI) wurden auf Patienten mit einem gewissen Restgehör erweitert. Das Einführen des Elektrodenträgers in die Cochlea mit einem potenziellen mechanischen Trauma durch die Anwesenheit dieses Fremdkörpers in der Cochlea kann jedoch zur Bildung freier Radikale und zu einer verminderten Durchblutung der Cochlea führen, was den Verlust des Restgehörs zur Folge haben kann. In dieser randomisierten, plazebokontrollierten, doppelblinden klinischen Studie wird die Wirkung von Radikalfängern und einem Vasodilatator auf das Resthörvermögen untersucht. Das Nahrungsergänzungsmittel besteht aus β-Carotin (Vitamin A), Ascorbinsäure (Vitamin C), dl-α-Tocopherolacetat (Vitamin E) und dem gefäßerweiternden Magnesium (Mg), kurz ACEMg. Die primäre Maßnahme basiert auf der Reduktion der postoperativen niederfrequenten Luftleitungs-Reintonschwellen bei ACEMg-behandelten Patienten im Vergleich zu denen einer Placebogruppe.
Language of the description : German

Description : The indications for a cochlear implant (CI) have been extended to include patients with some residual hearing. However, insertion of the electrode array into the cochlea with potential mechanical trauma due to the presence of this foreign body in the cochlea can lead to the formation of free radicals and reduced blood flow to the cochlea, resulting in loss of residual hearing. In this randomized, placebo-controlled, double-blind clinical trial, the effect of radical scavengers and a vasodilator on residual hearing is investigated. The food supplement consists of β-carotene (vitamin A), ascorbic acid (vitamin C), dl-α-tocopherol acetate (vitamin E) and the vasodilating magnesium (Mg), ACEMg for short. The primary measure is based on the reduction of postoperative low frequency air conduction pure tone thresholds compared to the preoperative thresholds in ACEMg treated patients compared to those of a placebo group.
Language of the description : English

Keyword(s) describing the Project

Keyword(*) : Cochlea implant

Keyword(*) : food supplement

Language(s) of the project : English

Contributor(s) of the Project

Is it a personal or organisational contribution?(*) : Personal
Details about the contributing organisation(s)/institution(s)/group(s)
Contributor type(*) : Not specified
Funding identifier(s) : Not specified
Name of the organisation/institution/group(*) : Not specified
Details about the contributing person(s)
Contributor type(*) : Principal investigator
Given name(*) : Thomas
Family name(s)(*) : Lenarz
Digital identifier(s)
Identifier(*) : Not specified
Scheme(*) : Not specified
Email address : Lenarz.Thomas@mh-hannover.de
Phone number : +49-511-532-6562
Organisation(s) associated with the contributor
Name(*) : Medizinische Hochschule Hannover
Address : Carl Neuberg Straße 1, 30625 Hannover, DE
Web page : Not specified
Digital identifier(s)
Identifier(*) : Not specified
Scheme(*) : Not specified

Alternative identifiers

Type of the registry(*) : DRKS
Identifier(*) : DRKS00021627

Characteristics of the Project

Is it an interventional or non-interventional Project? : Interventional
Specification of the type of the Project
Interventional Project type : Parallel
Non-interventional Project type : []
Primary health condition(s) or disease(s) considered in the Project
Primary health condition or disease name(*) : Conductive and sensorineural hearing loss
Terminology/classification(*) : ICD-10
Code of the health condition or disease : Not specified
Groups of diseases or conditions(*)
Which groups of diseases or conditions were the data collected on? : Diseases of the ear or mastoid process (VIII)
On which diseases or conditions were the data collected? : []
Collects mortality data? : Not specified
Administrative information about the Project
Status of the ethics committee approval : Request for approval submitted, approval granted
Overall Project status : Ongoing (IV): Recruitment and data collection completed, but data quality management ongoing
Participants enrolled by invitation? : No
Start date : 15 June 2020
End date : 28 April 2025
Mono- or multicentric? : Monocentric
Number of centers : Not specified
One or more data providers? : Not specified
Number of data providers : Not specified
Primary subject(*) : Person
Eligibility criteria for Project participants
Eligibility criteria: Minimum age
Minimum eligible age(*) : 18
Unit of age(*) : Years
Eligibility criteria: Maximum age
Maximum eligible age(*) : Not specified
Unit of age(*) : Not specified
Eligible gender : Male, Female, Diverse
Inclusion criteria : . Intended to receive a hearing or structure preservation cochlear implant 3. Residual hearing less or equal than 85 dB HL at 125 Hz, 90 dB HL at 250 Hz and 95 dB HL at 500 Hz in the ear to be implanted at last routine appointment 4. Ability to understand the study procedures, possible risks and benefits, and to give informed consent. 5. Informed Consent is signed. 6. Patients must agree not to use daily vitamin preparations containing vitamin A, C or E or magnesium during the course of the study, and beginning at least 24 hours prior to first intake of the study medication
Exclusion criteria : 1. Pregnancy or lactation 2. Additional handicaps that would prevent participation in evaluations 3. Pre-existing conditions: 3.1 hepatopathy 3.2 severe renal insufficiency 3.3 disposition to kidney stones 3.4 iron-storage disease (thalassemia, hemochromatosis, sideroblastic anemia) 3.5 co-medication with vitamin K-antagonists 3.6 heavy smoking (≥ 10 cigarettes per day) 4. Current participation in any other interventional study and/or participation in another interventional study within 30 days before the study begins
Population of the Project(*)
Coverage : National
Country(ies) : Germany
Region(s) and/or city(ies) : Not specified
Interventions of the Project
Name of the intervention(*) : Verum
Type of the intervention : Drug (including placebo)
Additional information about the intervention : Verum-Group: Intake over 105-106 days, 3 capsules twice a day, to be taken orally; Composition of ACEMg: Vitamin E Acetate, EV Substance Code SUB35355, 44,5 mg Beta-Carotene, EV-Substance Code SUB22485, 3,0mg Ascorbis Acid, EV-Substance Code SUB3009MIG, 83,33 mg Magnesium, EV-Substance Code SUB14407MIG, 52,5 mg
Name(s) of the arm(s) associated with the given intervention : Verum
Name of the intervention(*) : Placebo
Type of the intervention : Drug (including placebo)
Additional information about the intervention : Placebo-Group: Intake over 105-106 days, 3 capsules twice a day, to be taken orally
Name(s) of the arm(s) associated with the given intervention : Placebo
Exposures of the Project
Name of the exposure : Not specified
Type of the exposure : Not specified
Additional information about the exposure : Not specified
Name(s) of the group(s) associated with the given exposure : Not specified
Outcome measures in the Project
Name of the outcome measure(*) : Hearing loss at the implanted ear at 500 Hz 3 months post First Fitting (hearing loss = 3 months post First Fitting threshold minus 1-2 days pre-operatively threshold) measured by air conducted pure tone audiometry in ACEMg individuals compared to placebo controls.
Description of the outcome measure : Not specified
Type of the outcome measure : Primary
Time point(s) of assessment : 3 months post first-fitting
Name of the outcome measure(*) : Hearing loss at the implanted ear measured by pure tone audiometry at 500 Hz day 1 of First Fitting and 6 months post First Fitting
Description of the outcome measure : Not specified
Type of the outcome measure : Secondary
Time point(s) of assessment : Not specified
Name of the outcome measure(*) : Hearing loss measured by pure tone audiometry for 125 and 250 Hz over time (day 1 of First Fitting, months 3 and 6 post First Fitting)
Description of the outcome measure : Not specified
Type of the outcome measure : Secondary
Time point(s) of assessment : Not specified
Name of the outcome measure(*) : Speech perception by OLSA, month 6 after First Fitting
Description of the outcome measure : Not specified
Type of the outcome measure : Secondary
Time point(s) of assessment : Not specified
Name of the outcome measure(*) : Impedances at all time points (First Fitting day 1 and day 3, month 3 and month 6 after First Fitting)
Description of the outcome measure : Not specified
Type of the outcome measure : Secondary
Time point(s) of assessment : Not specified
Name of the outcome measure(*) : All SAEs
Description of the outcome measure : Not specified
Type of the outcome measure : Secondary
Time point(s) of assessment : Not specified
Name of the outcome measure(*) : All AEs
Description of the outcome measure : Not specified
Type of the outcome measure : Secondary
Time point(s) of assessment : Not specified
Additional information about the Project : Not specified
Additional assessments/measurements in the Project : []
Data sharing strategy of the Project(*)
Is it planned to share the data?(*) : No, there is no plan to make data available
Supporting documents available in addition to the data : []
When and for how long will the data be available? : Not specified
Criteria for data access : Not specified
Additional information about data sharing : Not specified
DataSHIELD/Opal infrastructure available? : Not specified
Link to data request application : Not specified
Web page with additional information about data sharing : Not specified
Record linkage possible? : false
Non-interventional aspects of the Project
Temporal design : []
Target follow-up duration of the Project
Target follow-up duration(*) : Not specified
Unit of time(*) : Not specified
Number of follow-ups conducted : Not specified
Biosamples retained in a biorepository : []
Specific types of retained biosamples : Not specified
Interventional aspects of the Project
Numerical phase : Not applicable
Masking of intervention(s) assignment
Masking implemented? : true
Who is masked? : Participant, Investigator
Additional information about masking : Not specified
Type of allocation of participants to an arm : Randomized
Off-label use of a drug product : No

FIPPI-CI

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