Mitochondrial Genetics of Presbycusis
MITOPRES
1 other identifier
observational
200
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2019
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 24, 2018
CompletedFirst Posted
Study publicly available on registry
October 26, 2018
CompletedStudy Start
First participant enrolled
April 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2023
CompletedApril 11, 2019
April 1, 2019
3.6 years
October 24, 2018
April 9, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
identification of mitochondrial mutations associated with presbycusis
Enrichment analysis will be perfomed with CHI2 test after Benjamini correction.
the analysis will be conducted at the end of the inclusion of the 200 patients
Secondary Outcomes (2)
identification of genomic variants associated with presbycusis
the analysis will be conducted at the end of the inclusion of the 200 patients
identification of DNA variants associated with environmental susceptibility
the analysis will be conducted at the end of the inclusion of the 200 patients
Other Outcomes (1)
identification of clinical features predicting some presbycusis forms
the analysis will be conducted at the end of the inclusion of the 200 patients
Study Arms (2)
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
Eligibility Criteria
The study is proposed to patients consulting for hearing evaluation in ENT department of University Hospital of Angers.
You may qualify if:
- 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
You may not qualify if:
- deafness diagnosed before 40 years old
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
UH Angers
Angers, 49933, France
Biospecimen
DNA extracted from blood and urine will be stored in "Centre de Ressources Biologiques" as planed in biocollections "maladies mitochondriales" and "volontaires sains"
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 24, 2018
First Posted
October 26, 2018
Study Start
April 1, 2019
Primary Completion
November 1, 2022
Study Completion
November 1, 2023
Last Updated
April 11, 2019
Record last verified: 2019-04