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Hearing Aid Impact on Chronic Tinnitus Patients Evaluated by Resting State PET.

Primary Purpose

Chronic Tinnitus

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
hearing aid fitting
Sponsored by
University of Sao Paulo General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Tinnitus focused on measuring hearing loss, tinnitus, neuroimaging, hearing aids, Positron emission Tomography - PET

Eligibility Criteria

32 Years - 62 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria::

  1. chronic perception of tinnitus for more than 6 months;
  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:

  1. unilateral, mixed or conductive hearing loss;
  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 -

Sites / Locations

  • University of Sao PauloRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control

Tinnitus

Arm Description

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 Patients with tinnitus and hearing loss associated Hearing aided fitted PET image acquisition before and after 6 months og Hearing aid usage.

Outcomes

Primary Outcome Measures

PET RESULTS
After an individual whole brain analysis, a within-subject analysis was performed by comparing pre-treatment and post-treatment situation. The analysis revealed increased and decreased glycolytic metabolism areas for each subject, after intervention. For group analysis we used paired-t-tests. These analyses produced parametric statistical maps, which were then converted into a normal distribution unit (Z-scores). The significance threshold was set at p<0.05, and corrected for multiple comparisons (FWE or family-wise error rate), either at the voxel or cluster-level.

Secondary Outcome Measures

Tinnitus Handicap Inventory (THI)
The THI consists of 25 questions distributed on three scales that evaluate different tinnitus aspects: functional, emotional and catastrophic. The options for responding to THI questions are: yes (4 points), sometimes (2 points), and no (0 points). On a scale from 0-100, 0-16 points signifies negligible tinnitus, 18-36 signifies mild tinnitus, 38-56 signifies moderate tinnitus, 58-76 signifies severe tinnitus, and 78-100 signifies catastrophic tinnitus. Reductions on scale signifies tinnitus perception are reduced.Results of self-assessment questionnaires and their respective subscales were described according to the follow up evaluation moment. They were all analyzed statistically.
Hearing Handicap Inventory for Adults (HHIA)
Composed of 25 questions that evaluate social and emotional aspects of hearing disability. Subjects had three choices: yes (4 points), sometimes (2 points) and no (0 points). On a scale from zero to 100, scores higher than 44 points indicate severe handicap, from 18-42 points indicate moderate handicap and below 18 indicate no handicap. After intervention, reductions on scale means less hearing handicap.Results of self-assessment questionnaires and their respective subscales were described according to the follow up evaluation moment. They were all analyzed statistically.
Visual Analog Scale ( VAS)
The VAS is a numeric scale ranging from 0-10. Subjects assigned a value to tinnitus annoyance based on this visual scale. High scores means high degree of tinnitus annoyance.Results were described according to the follow up evaluation moment. and then analyzed statistically.

Full Information

First Posted
July 11, 2018
Last Updated
August 31, 2018
Sponsor
University of Sao Paulo General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03657615
Brief Title
Hearing Aid Impact on Chronic Tinnitus Patients Evaluated by Resting State PET.
Official Title
Hearing Aid Impact on Chronic Tinnitus Patients With Associated Hearing Loss Evaluated by Resting State Positron Emission Tomography (PET).
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Unknown status
Study Start Date
January 15, 2014 (Actual)
Primary Completion Date
September 30, 2018 (Anticipated)
Study Completion Date
June 30, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Sao Paulo General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Using resting state positron emission tomography (PET), our goal was to analyze the metabolic and functional neural changes that occur after 6 months of effective hearing aid (HA) use. Besides, we correlate those changes with behavioral results. Patients with chronic tinnitus and untreated sensorineural hearing loss were tested pre-HA fitting, and at 6 months post-HA fitting.
Detailed Description
Subjects are selected as they are enrolled in the Tinnitus Research Group between January 2014 and September 2018. The study was approved by the local medical ethics committee for research at the Medical School of University of São Paulo - protocol number 611.174 in April, 2014. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Tinnitus
Keywords
hearing loss, tinnitus, neuroimaging, hearing aids, Positron emission Tomography - PET

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
within subject
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Tinnitus
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
hearing aid fitting
Other Intervention Name(s)
hearing amplification
Intervention Description
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.
Primary Outcome Measure Information:
Title
PET RESULTS
Description
After an individual whole brain analysis, a within-subject analysis was performed by comparing pre-treatment and post-treatment situation. The analysis revealed increased and decreased glycolytic metabolism areas for each subject, after intervention. For group analysis we used paired-t-tests. These analyses produced parametric statistical maps, which were then converted into a normal distribution unit (Z-scores). The significance threshold was set at p<0.05, and corrected for multiple comparisons (FWE or family-wise error rate), either at the voxel or cluster-level.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Tinnitus Handicap Inventory (THI)
Description
The THI consists of 25 questions distributed on three scales that evaluate different tinnitus aspects: functional, emotional and catastrophic. The options for responding to THI questions are: yes (4 points), sometimes (2 points), and no (0 points). On a scale from 0-100, 0-16 points signifies negligible tinnitus, 18-36 signifies mild tinnitus, 38-56 signifies moderate tinnitus, 58-76 signifies severe tinnitus, and 78-100 signifies catastrophic tinnitus. Reductions on scale signifies tinnitus perception are reduced.Results of self-assessment questionnaires and their respective subscales were described according to the follow up evaluation moment. They were all analyzed statistically.
Time Frame
6 months
Title
Hearing Handicap Inventory for Adults (HHIA)
Description
Composed of 25 questions that evaluate social and emotional aspects of hearing disability. Subjects had three choices: yes (4 points), sometimes (2 points) and no (0 points). On a scale from zero to 100, scores higher than 44 points indicate severe handicap, from 18-42 points indicate moderate handicap and below 18 indicate no handicap. After intervention, reductions on scale means less hearing handicap.Results of self-assessment questionnaires and their respective subscales were described according to the follow up evaluation moment. They were all analyzed statistically.
Time Frame
6 months
Title
Visual Analog Scale ( VAS)
Description
The VAS is a numeric scale ranging from 0-10. Subjects assigned a value to tinnitus annoyance based on this visual scale. High scores means high degree of tinnitus annoyance.Results were described according to the follow up evaluation moment. and then analyzed statistically.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
32 Years
Maximum Age & Unit of Time
62 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:: chronic perception of tinnitus for more than 6 months; THI score greater than 38; bilateral and symmetric hearing loss not exceeding 70 decibels (dB) hearing threshold; no previous experience with HA. - Exclusion Criteria: unilateral, mixed or conductive hearing loss; pulsatile or myoclonic tinnitus;; anxiety and depression detected by GAD-7 and PHQ-9; significant visual, motor or cognitive deficits; pregnant women and diabetic patients history of drug abuse -
Facility Information:
Facility Name
University of Sao Paulo
City
São Paulo
State/Province
Sao Paulo
ZIP/Postal Code
05403000
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeanne Oiticica, MD PhD
Phone
+551130880299
Email
jeanneramalho@uol.com.br
First Name & Middle Initial & Last Name & Degree
Juliana Anauate, MD
Phone
+5511982921245
Email
juliana.anauate@gmail.com
First Name & Middle Initial & Last Name & Degree
Patricia Simonetti, MD PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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Hearing Aid Impact on Chronic Tinnitus Patients Evaluated by Resting State PET.

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