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

University of Sao Paulo General Hospital

Status: Unknown

Conditions: Chronic Tinnitus

Treatments: Device: hearing aid fitting

Study type: Interventional

Funder types: Other

Identifiers

NCT03657615

USaoPauloCF

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 32 to 62 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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 -

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

Control

Active Comparator group

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.

Treatment:

Device: hearing aid fitting

Tinnitus

Experimental group

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.

Treatment:

Device: hearing aid fitting