Clinical trial NCT03657615: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Tinnitus
Keywords: hearing loss
tinnitus
neuroimaging
hearing aids
Positron emission Tomography - PET
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
First posted: 2018-09-05
Enrollment: 40
Sex: ALL
Minimum age (years): 32
Maximum age (years): 62
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: within subject
Primary purpose: TREATMENT

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.

Eligibility 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 -

Primary outcomes:
measure: PET RESULTS
timeFrame: 6 months
Secondary outcomes:
measure: Tinnitus Handicap Inventory (THI)
timeFrame: 6 months
measure: Hearing Handicap Inventory for Adults (HHIA)
timeFrame: 6 months
measure: Visual Analog Scale ( VAS)
timeFrame: 6 months
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: University of Sao Paulo
state: Sao Paulo
Study officials:
References: