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Mitochondrial Genetics of Presbycusis (MITOPRES)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03720964
Recruitment Status : Unknown
Verified April 2019 by University Hospital, Angers.
Recruitment status was:  Recruiting
First Posted : October 26, 2018
Last Update Posted : April 11, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Angers

Study Description
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Brief Summary:
The main goal of this study is to identify mitochondrial mutations associated with presbycusis. Patients affected by severe presbycusis and normal hearing controls (according to ISO7029 norm) will be enrolled if satisfying inclusion criteria (aged from 40 to 80 years old) in existing biocollections in the University Hospital of Angers. After DNA extraction, the mitochondrial genome will be sequenced and data in silico analysed.

Condition or disease
Presbycusis Age Related Hearing Loss

Detailed Description:

The study will be proposed to patients consulting in the ENT department of the University Hospital of Angers. After clinical examination and audiometry recording, the eligibility criteria will be checked and inclusion in biocollections proposed. Presbycusis affected subjects will be enrolled in "Mitochondrial Disease biocollection" and normal hearing controls in "Healthy Volunteer biocollection". These biocollections have been approved by the board comitee "Centre de Protection des Personnes".

After DNA extraction and mitochondrial sequencing, candidate variants will be selected by in silico analysis. The presence of mitochondrial variants in both groups (presbycusis and control) will be compared in multivariate analysis if needed.

The nuclear DNA may be sequenced in order to complete the previous analysis and look for any candidate variant .

Study Design
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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Mitochondrial Genetics of Presbycusis
Estimated Study Start Date : April 2019
Estimated Primary Completion Date : November 2022
Estimated Study Completion Date : November 2023

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
presbycusis affected patients
affected by a more severe age related hearing loss than expected according to the norm ISO 7029
controls
not affected by age related hearing loss according to the norm ISO 7029


Outcome Measures
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Primary Outcome Measures :
  1. identification of mitochondrial mutations associated with presbycusis [ Time Frame: the analysis will be conducted at the end of the inclusion of the 200 patients ]
    Enrichment analysis will be perfomed with CHI2 test after Benjamini correction.


Secondary Outcome Measures :
  1. identification of genomic variants associated with presbycusis [ Time Frame: the analysis will be conducted at the end of the inclusion of the 200 patients ]
    enrichment of genomic variants will be analysed

  2. identification of DNA variants associated with environmental susceptibility [ Time Frame: the analysis will be conducted at the end of the inclusion of the 200 patients ]
    subgroup analysis will be performed in accordance with environmental exposition


Other Outcome Measures:
  1. identification of clinical features predicting some presbycusis forms [ Time Frame: the analysis will be conducted at the end of the inclusion of the 200 patients ]
    analysis of audiometric data after genetic analysis will be performed


Biospecimen Retention:   Samples With DNA
DNA extracted from blood and urine will be stored in "Centre de Ressources Biologiques" as planed in biocollections "maladies mitochondriales" and "volontaires sains"

Eligibility Criteria
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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
The study is proposed to patients consulting for hearing evaluation in ENT department of University Hospital of Angers.
Criteria

Inclusion Criteria:

  • age related hearing loss more severe than the predicted hearing thresholds according to the norm ISO7029, for the presbycusis population;
  • normal hearing according to norm ISO7029 for the control population

Exclusion Criteria:

  • deafness diagnosed before 40 years old
  • exclusion criteria of one of the biocollection
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03720964


Contacts
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Contact: Dr Sophie Boucher 0241353989 sophie.boucher@chu-angers.fr
Contact: Alban Ziegler, MD 0241353883 alban.ziegler@chu-angers.fr

Locations
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France
UH Angers Recruiting
Angers, France, 49933
Contact: sophie Boucher, MD         
Sponsors and Collaborators
University Hospital, Angers
More Information
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Responsible Party: University Hospital, Angers
ClinicalTrials.gov Identifier: NCT03720964    
Other Study ID Numbers: 49RC18_0148
First Posted: October 26, 2018    Key Record Dates
Last Update Posted: April 11, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hearing Loss
Presbycusis
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
 Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Hearing Loss, Sensorineural