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

August 31, 2018 updated by: University of Sao Paulo General Hospital

Hearing Aid Impact on Chronic Tinnitus Patients With Associated Hearing Loss Evaluated by Resting State Positron Emission Tomography (PET).

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Sao Paulo
      • São Paulo, Sao Paulo, Brazil, 05403000
        • Recruiting
        • University of Sao Paulo
        • Contact:
        • Contact:
        • Principal Investigator:
          • Patricia Simonetti, MD PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

32 years to 62 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 -

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
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 Names:
  • hearing amplification
Experimental: 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.
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 Names:
  • hearing amplification

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PET RESULTS
Time Frame: 6 months
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.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tinnitus Handicap Inventory (THI)
Time Frame: 6 months
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.
6 months
Hearing Handicap Inventory for Adults (HHIA)
Time Frame: 6 months
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.
6 months
Visual Analog Scale ( VAS)
Time Frame: 6 months
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.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 15, 2014

Primary Completion (Anticipated)

September 30, 2018

Study Completion (Anticipated)

June 30, 2019

Study Registration Dates

First Submitted

July 11, 2018

First Submitted That Met QC Criteria

August 31, 2018

First Posted (Actual)

September 5, 2018

Study Record Updates

Last Update Posted (Actual)

September 5, 2018

Last Update Submitted That Met QC Criteria

August 31, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Chronic Tinnitus

Clinical Trials on hearing aid fitting

Subscribe