Normal Hearing (76 Subjects)NCT01132092
The Normal Standard of Brainstem Auditory Evoked Potential in Adults Using a New Device
An observational study of Normal Hearing (76 Subjects) and Subjects With Hearing Loss (15 Subjects), run by Universidade Estadual de Ciências da Saúde de Alagoas at 1 site in Brazil.
Trial summary
There are no differences between the exams made with the new device,that evaluates the hearing, and the device gold standard, that is widely used in clinics and hospitals. Read more about this study
- Who is it for?
- Ages 25 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Normal Hearing (76 Subjects), Subjects With Hearing Loss (15 Subjects)
- How many people
- Not given
- Where
- 1 siteBrazil
- Study dates
- Start not givento not given
- 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 25 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Adults Normal hearing subjects and hearing loss Subjects
Who may be able to join
- hearing thresholds less than 25 dB at all frequencies of pure tone audiometry, with differences between the ears, by frequency, or less than 10 dB.
- The group with bilateral sensorineural hearing loss was made up of adults with hearing thresholds changed from 25 to 60 dB HL for the frequencies 2000-8000 Hz for pure tone audiometry.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Universidade Estadual de Ciências da Saúde de Alagoas
Maceió, Alagoas, 57010-300
About this study
There are no differences between the exams made with the new device,that evaluates the hearing, and the device gold standard, that is widely used in clinics and hospitals.
- Keywords
- Evoked Potentials, Adult, Hearing Loss
- Medical subject headings
- Hearing Loss
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 |
|---|---|---|
| Normal hearing (experimental 1) | 76 Normal hearing subjects, male and female, adults, , evaluated by new device | |
| Normal hearing (experimental 2) | 15 Normal hearing subjects, male and female, adults, , evaluated by new device | |
| Hearing loss (experimental 3) | 15 hearing loss subjects, male and female, adults, evaluated by new device | |
| Gold standard 1 | 15 Normal hearing subjects, male and female, adults, evaluated by gold standard device | |
| Gold Standard 2 | 15 hearing loss subjects, male and female, adults, evaluated by gold standard device |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Normal Hearing (76 Subjects)Studies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
Sponsor and investigators
- Lead sponsor
- Universidade Estadual de Ciências da Saúde de Alagoas
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01132092
- Sponsor's protocol ID
- UNCISAL-IS-001
- Status last verified
- May 2010
- First submitted
- 26 May 2010
- Last updated
- 27 May 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Normal Standard of Brainstem Auditory Evoked Potential in Adults Using a New Device
- ClinicalTrials.gov ID
- NCT01132092
- Acronym / sponsor ID
- UNCISAL-IS-001
- Keywords
- Evoked Potentials, Adult, Hearing Loss
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- Universidade Estadual de Ciências da Saúde de AlagoasUniversity, hospital or other
- First posted
- 27 May 2010 (estimated)
- 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.
There are no differences between the exams made with the new device,that evaluates the hearing, and the device gold standard, that is widely used in clinics and hospitals.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Normal hearing (experimental 1) | – | –76 Normal hearing subjects, male and female, adults, , evaluated by new device |
| Normal hearing (experimental 2) | – | –15 Normal hearing subjects, male and female, adults, , evaluated by new device |
| Hearing loss (experimental 3) | – | –15 hearing loss subjects, male and female, adults, evaluated by new device |
| Gold standard 1 | – | –15 Normal hearing subjects, male and female, adults, evaluated by gold standard device |
| Gold Standard 2 | – | –15 hearing loss subjects, male and female, adults, evaluated by gold standard device |
Who may qualify
- Ages
- 25 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Adults Normal hearing subjects and hearing loss Subjects
Key inclusion criteria (2 listed)
- hearing thresholds less than 25 dB at all frequencies of pure tone audiometry, with differences between the ears, by frequency, or less than 10 dB.
- The group with bilateral sensorineural hearing loss was made up of adults with hearing thresholds changed from 25 to 60 dB HL for the frequencies 2000-8000 Hz for pure tone audiometry.
Key exclusion criteria (1 listed)
- -
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
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2010.
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Normal Hearing (76 Subjects) and Subjects With Hearing Loss (15 Subjects), run by Universidade Estadual de Ciências da Saúde de Alagoas at 1 site in Brazil.
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: finished, as of the sponsor's last update on 27 May 2010. 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 Brazil. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
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 27 May 2010.