NCT03657615

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 15, 2014

Completed
4.5 years until next milestone

First Submitted

Initial submission to the registry

July 11, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 5, 2018

Completed
25 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2018

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2019

Completed
Last Updated

September 5, 2018

Status Verified

July 1, 2018

Enrollment Period

4.7 years

First QC Date

July 11, 2018

Last Update Submit

August 31, 2018

Conditions

Chronic Tinnitus

Keywords

hearing losstinnitusneuroimaginghearing aidsPositron emission Tomography - PET

Outcome Measures

Primary Outcomes (1)

  • 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.

    6 months

Secondary Outcomes (3)

  • Tinnitus Handicap Inventory (THI)

    6 months

  • Hearing Handicap Inventory for Adults (HHIA)

    6 months

  • Visual Analog Scale ( VAS)

    6 months

Study Arms (2)

Control

ACTIVE COMPARATOR

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.

Device: hearing aid fitting

Tinnitus

EXPERIMENTAL

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.

Device: hearing aid fitting

Interventions

hearing aid fittingDEVICE

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.

Also known as: hearing amplification
ControlTinnitus

Eligibility Criteria

Age32 Years - 62 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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. -

You may not qualify if:

  • 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 -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Sao Paulo

São Paulo, São Paulo, 05403000, Brazil

RECRUITING

MeSH Terms

Conditions

Hearing LossTinnitus

Condition Hierarchy (Ancestors)

Hearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: within subject
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 11, 2018

First Posted

September 5, 2018

Study Start

January 15, 2014

Primary Completion

September 30, 2018

Study Completion

June 30, 2019

Last Updated

September 5, 2018

Record last verified: 2018-07

Data Sharing

IPD Sharing
Will not share

Locations

BR(1)