Hearing Aid Impact on Chronic Tinnitus Patients With Associated Hearing Loss Evaluated by Resting State Positron Emission Tomography (PET).
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- PET RESULTS
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 32 Years 至 62 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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. -
排除标准
- •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 -
结局指标
主要结局
PET RESULTS
时间窗: 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.
次要结局
- Hearing Handicap Inventory for Adults (HHIA)(6 months)
- Visual Analog Scale ( VAS)(6 months)
- Tinnitus Handicap Inventory (THI)(6 months)