Chronic Tinnitus Clinical Trial
Official title:
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.
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.
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