PresbycusisMITOPRESNCT03720964
Mitochondrial Genetics of Presbycusis
An observational study of Presbycusis and Age Related Hearing Loss, run by University Hospital, Angers at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Presbycusis, Age Related Hearing Loss
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2019to Nov 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study is proposed to patients consulting for hearing evaluation in ENT department of University Hospital of Angers.
Who may be able to join
- 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
Who cannot join
- deafness diagnosed before 40 years old
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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 .
- Conditions
- Presbycusis, Age Related Hearing Loss
- Medical subject headings
- Presbycusis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
identification of mitochondrial mutations associated with presbycusis
Enrichment analysis will be perfomed with CHI2 test after Benjamini correction.
Measured: 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
enrichment of genomic variants will be analysed
Measured: the analysis will be conducted at the end of the inclusion of the 200 patients
identification of DNA variants associated with environmental susceptibility
subgroup analysis will be performed in accordance with environmental exposition
Measured: the analysis will be conducted at the end of the inclusion of the 200 patients
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2018
- Study startApr 2019 (estimated)
- Primary completionNov 2022 (estimated)
- Study completionNov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PresbycusisStudies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03720964
- Sponsor's protocol ID
- 49RC18_0148
- Acronym
- MITOPRES
- Status last verified
- Apr 2019
- First submitted
- 24 Oct 2018
- Last updated
- 11 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mitochondrial Genetics of Presbycusis
- ClinicalTrials.gov ID
- NCT03720964
- Acronym / sponsor ID
- MITOPRES / 49RC18_0148
- Conditions
- Presbycusis, Age Related Hearing Loss
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- Apr 2019 (estimated)
- Primary completion
- Nov 2022 (estimated)
- Study completion
- Nov 2023 (estimated)
- First posted
- 26 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study is proposed to patients consulting for hearing evaluation in ENT department of University Hospital of Angers.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- deafness diagnosed before 40 years old
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
2 secondary outcomes
identification of genomic variants associated with presbycusis
Time frame: the analysis will be conducted at the end of the inclusion of the 200 patients
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Presbycusis and Age Related Hearing Loss, run by University Hospital, Angers at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dr Sophie Boucher (0241353989, sophie.boucher@chu-angers.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
identification of mitochondrial mutations associated with presbycusis (time frame: the analysis will be conducted at the end of the inclusion of the 200 patients). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2019.