Hearing Aid Impact on Chronic Tinnitus Patients Evaluated by Resting State PET.
NCT ID: NCT03657615
Last Updated: 2018-09-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
40 participants
INTERVENTIONAL
2014-01-15
2019-06-30
Brief Summary
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Detailed Description
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All the procedures were performed after medical evaluation and a complete tinnitus evaluation protocol, which included somatosensory assessment, self-related questionnaires for tinnitus and hearing: Tinnitus Handicap Inventory (THI), Hearing Handicap Inventory for Adults (HHIA), and , for anxiety and depression symptoms: Generalized Anxiety Depression Scale (GAD-7) and Patient Health Questionnaire (PHQ-9), and for neck pain (Neck Disability Index, NDI). The subjects of this study were also blood tested for pregnancy and diabetes, which may interfere on fluorodeoxyglucose (FDG)-positron emission tomography PET acquisition.
All subjects underwent hearing and tinnitus evaluation, counseling and hearing aid fitting.
To prescribe and verify acoustic response, we used the HA fitting protocol recommended by the National Acoustics Laboratories (NAL), named NAL NL-2 (NL-non linear) FDG-PET measurements were obtained at baseline (prior to HA fitting) and after 6 months of HA use.
Regarding FDG-PET images, a within-subject analysis was performed by comparing pre-treatment and post-treatment group using paired-t-tests.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Control
Hearing Aid Fitting Patients with hearing loss but no tinnitus paired by age and hearing loss degree Hearing aided fitted PET image acquisition before and after 6 months og Hearing aid usage.
hearing aid fitting
All patients were fitted bilaterally with hearing aids for hearing loss compensation. . Apart from different HAs used, device selection followed strict criteria to fit hearing loss demands, patient profile, resources and algorithms recommended for tinnitus patients.
Tinnitus
Hearing Aid Fitting Patients with tinnitus and hearing loss associated Hearing aided fitted PET image acquisition before and after 6 months og Hearing aid usage.
hearing aid fitting
All patients were fitted bilaterally with hearing aids for hearing loss compensation. . Apart from different HAs used, device selection followed strict criteria to fit hearing loss demands, patient profile, resources and algorithms recommended for tinnitus patients.
Interventions
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hearing aid fitting
All patients were fitted bilaterally with hearing aids for hearing loss compensation. . Apart from different HAs used, device selection followed strict criteria to fit hearing loss demands, patient profile, resources and algorithms recommended for tinnitus patients.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. THI score greater than 38;
3. bilateral and symmetric hearing loss not exceeding 70 decibels (dB) hearing threshold;
4. no previous experience with HA. -
Exclusion Criteria
2. pulsatile or myoclonic tinnitus;;
3. anxiety and depression detected by GAD-7 and PHQ-9;
4. significant visual, motor or cognitive deficits;
5. pregnant women and diabetic patients
6. history of drug abuse -
32 Years
62 Years
ALL
No
Sponsors
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University of Sao Paulo General Hospital
OTHER
Responsible Party
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Locations
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University of Sao Paulo
São Paulo, São Paulo, Brazil
Countries
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Facility Contacts
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Other Identifiers
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USaoPauloCF
Identifier Type: -
Identifier Source: org_study_id
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