跳至主要内容
临床试验/NCT04705246
NCT04705246尚未招募不适用

Effect of Psychoeducation Upon Exposure to Sounds and Hyperacusis Severity

University Hospital, Antwerp0 个研究点目标入组 5 人开始时间: 2025年12月7日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
5
主要终点
Change in EMA questions from baseline to end of the study

研究概览

简要总结

This study focuses on patients with a primary complaint of hyperacusis. Hyperacusis has been defined as 'abnormally reduced tolerance to sound'. It shows a high comorbidity with tinnitus, the perception of sound in the absence of a sound source. For the period of one month, hyperacusis and tinnitus severity and exposure to sounds will be evaluated by use of Ecological Momentary Assessment (EMA) in all participants. A novel approach to assessments, EMA prompts participants during their daily life to answer short questionnaires, increasing ecological validity and minimizing the risk for recall and memory biases. At a randomized time point during the one-month period, participants will individually receive a single psychoeducation session (1h) delivered by an experienced audiologist. The goal of the study is to investigate if the psychoeducation session leads to an increase in exposure to sound and a decrease in hyperacusis severity.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •primary complaint of hyperacusis

排除标准

  • •primary complaint of misophonia
  • •primary complaint of tinnitus
  • •undergoing another therapy at the moment of the study

研究组 & 干预措施

Psychoeducation

Experimental

The goal of the psychoeducation session is to provide insight in the hyperacusis symptoms, take away the fear of external noises, and encourage exposure to noise.

干预措施: Psychoeducation (Behavioral)

结局指标

主要结局

Change in EMA questions from baseline to end of the study

时间窗: 8 random time points each day during the period of the study, from baseline and after intervention, though study completion for an average of 1 month

Change in questions concerning exposure, hyperacusis and tinnitus during the day from baseline measurement to last day of the study period

次要结局

  • Hyperacusis Questionnaire(before intervention, immediately post intervention)
  • Tinnitus Functional Index (TFI)(before intervention, immediately post intervention)

研究者

申办方类型
Other
责任方
Sponsor

相似试验