Hearing ImpairmentNCT01261104
Relationship Between Hearing Thresholds, Handicap and Time for Treatment-seeking
An observational study of Hearing Impairment, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
Purpose: to investigate the relationship between time for treatment seeking and audiometric data and self-assessment of handicap for patients in a public hearing healthcare service. Methods: Retrospective study. Records of 152 elderly and 48 adults with hearing impairment were analyzed. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hearing Impairment
- How many people
- Not given
- Where
- 1 siteBrazil
- Study dates
- Apr 2010to Dec 2010
- 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 18 years and older
- All sexes
- Adult, Older adult
Study population: Hearing impaired adults and elderly attended at a public hearing healthcare service
Who may be able to join
- Older than 18 years old. Without experience with hearing aid use. Diagnosed with sensorineural hearing loss. Audiogram data available
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Relationship Between Hearing Thresholds, Handicap and Time for Treatment-seeking in a Public Hearing Healthcare Service
Purpose: to investigate the relationship between time for treatment seeking and audiometric data and self-assessment of handicap for patients in a public hearing healthcare service. Methods: Retrospective study. Records of 152 elderly and 48 adults with hearing impairment were analyzed. The ISO audiometric thresholds average (500 to 4000Hz) and high frequencies average (2000 to 6000Hz), the speech recognition thresholds and the total, social and emotional scores from the Hearing Handicap Inventory for the Adults (HHIA) and Elderly (HHIE) were compared with the time between the onset of hearing complaints and the first treatment seeking. Results: The average time for treatment seeking was 7,6 years. No statistical difference was found between ISO and high frequency audiometric average, HHIA/E scores and time for treatment seeking between adults and the elderly. Weak but significant negative correlations were observed between the audiometric data and time for treatment seeking. There was no relationship between the time for treatment seeking and educational, socioeconomic levels and perception of handicap. Conclusions: The search for treatment seems to be multifactorial. Despite technological advances and changes in access to information and treatment time for treatment seeking was similar to that reported 30 years ago.
- Conditions
- Hearing Impairment
- Keywords
- hearing loss, handicap, counseling
- 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 |
|---|---|---|
| Hearing impaired elderly | Not described | |
| Hearing impaired adults | Not described |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2010 (estimated)
- Study startApr 2010
- Primary completionOct 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hearing ImpairmentStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe 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
- Cohort
- Time perspective
- Retrospective
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Investigators
- Deborah Ferrari, PhD, Principal investigator, Faculdade de Odontologia de Bauru
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01261104
- Sponsor's protocol ID
- FOBCEP104/2010
- Status last verified
- Dec 2010
- First submitted
- 15 Dec 2010
- Last updated
- 16 Dec 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between Hearing Thresholds, Handicap and Time for Treatment-seeking in a Public Hearing Healthcare Service
- ClinicalTrials.gov ID
- NCT01261104
- Acronym / sponsor ID
- FOBCEP104/2010
- Conditions
- Hearing Impairment
- Keywords
- hearing loss, handicap, counseling
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- Oct 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 16 Dec 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.
Purpose: to investigate the relationship between time for treatment seeking and audiometric data and self-assessment of handicap for patients in a public hearing healthcare service. Methods: Retrospective study. Records of 152 elderly and 48 adults with hearing impairment were analyzed. The ISO audiometric thresholds average (500 to 4000Hz) and high frequencies average (2000 to 6000Hz), the speech recognition thresholds and the total, social and emotional scores from the Hearing Handicap Inventory for the Adults (HHIA) and Elderly (HHIE) were compared with the time between the onset of hearing complaints and the first treatment seeking. Results: The average time for treatment seeking was 7,6 years. No statistical difference was found between ISO and high frequency audiometric average, HHIA/E scores and time for treatment seeking between adults and the elderly. Weak but significant negative correlations were observed between the audiometric data and time for treatment seeking. There was no relationship between the time for treatment seeking and educational, socioeconomic levels and perception of handicap. Conclusions: The search for treatment seems to be multifactorial. Despite technological advances and changes in access to information and treatment time for treatment seeking was similar to that reported 30 years ago.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hearing impaired elderly | – | – |
| Hearing impaired adults | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Hearing impaired adults and elderly attended at a public hearing healthcare service
Key inclusion criteria (1 listed)
- Older than 18 years old. Without experience with hearing aid use. Diagnosed with sensorineural hearing loss. Audiogram data available
Key exclusion criteria (0 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 16 Dec 2010.
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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.
Deborah Ferrari, PhD principal investigator
Faculdade de Odontologia de Bauru
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 Hearing Impairment, run by University of Sao Paulo 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 1 inclusion and 0 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 16 Dec 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 16 Dec 2010.