Effect of a Dermal Biomodulator Patch on Subjective Tinnitus: a Randomized, Double-blind, Placebo-controlled Trial With 1-year Follow-up
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 91
- 试验地点
- 1
- 主要终点
- Change in Tinnitus Handicap Inventory (THI) Score from Baseline to Day 51
研究概览
简要总结
This study tested whether a skin patch, worn behind the ear, could help reduce tinnitus (ringing or buzzing in the ears) in adults. Eighty participants took part. Half wore an active patch, and half wore a patch that looked the same but had no active effect (a placebo). Neither the participants nor the researchers knew who received which patch until the study ended.
All participants also received an educational counseling session about tinnitus and how to manage it. Participants were assessed before treatment, three weeks later, about seven weeks later, and again about one year later. The researchers measured how much tinnitus affected their daily life, their sensitivity to sound, and their anxiety or mood.
详细描述
Tinnitus is a common condition without a universally accepted pharmacological treatment. The steady-state coherent biomodulator patch (Antinitus, Sensori AB, Sweden) uses passive, light photon-driven technology intended to influence water coherency in tissue and modulate neural activity along auditory pathways. Its performance and safety have previously been evaluated in earlier randomized controlled trials and post-market surveys, with follow-up data reported up to one year after treatment in prior literature.
This single-center, randomized, double-blind, placebo-controlled trial evaluated the clinical effectiveness of the biomodulator patch in adults with subjective tinnitus, examining both short-term and long-term (up to one year) outcomes. Participants were randomly assigned to receive either the active patch or a visually identical placebo patch, applied behind the ear and replaced daily for three weeks. Active and placebo patches were distributed in sealed envelopes to preserve blinding; neither participants nor investigators were aware of group allocation during the trial.
All participants received a standardized informative counseling session at study entry (approximately one hour), covering the auditory system, the nature and causes of tinnitus, available management approaches, and instruction on correct patch application.
Assessments were conducted at baseline, after 21 days of treatment, one month after treatment completion (day 51), and via telephone follow-up at approximately one year post-treatment. Continuous data are summarized as median and interquartile range given non-normal distributions. Within-group longitudinal changes were assessed using Wilcoxon signed-rank and Friedman tests; between-group comparisons used the Mann-Whitney U test. Exploratory correlation and regression analyses examined associations between tinnitus handicap, emotional distress, hyperacusis, age, and tinnitus duration at each assessment point.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Active and placebo patches were sealed in identical, indistinguishable envelopes by a third party, who recorded the allocation key separately. The investigator, who also served as the care provider and outcomes assessor (delivering counseling, dispensing patches, and administering weekly questionnaires), remained unaware of group allocation until the study concluded.
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
- •Age older than 18 years Subjective tinnitus for at least 4 weeks Absence of dermatological conditions that could cause skin irritation from patch application
排除标准
- •Currently undergoing active tinnitus therapy Known skin sensitivity
研究组 & 干预措施
Biomodulator Patch
Participants applied an active steady-state coherent biomodulator patch (Antinitus, Sensori AB, Sweden) behind the ear daily for three weeks. All participants in this arm also received a standardized one-hour informative counseling session at study entry, covering the auditory system, tinnitus, and management strategies
干预措施: Steady-State Coherent Biomodulator Patch (Antinitus) (Device)
Placebo Patch
Participants applied a placebo patch, visually indistinguishable from the active patch, behind the ear daily for three weeks. All participants in this arm also received the same standardized one-hour informative counseling session at study entry as the experimental group
干预措施: Placebo Patch (Device)
结局指标
主要结局
Change in Tinnitus Handicap Inventory (THI) Score from Baseline to Day 51
时间窗: Baseline and Day 51 (21 days post-treatment + 30 days)
THI is a 25-item questionnaire (score range 0-100), with higher scores indicating greater tinnitus-related handicap.
次要结局
- Change in THI Score from Baseline to Day 21(Baseline and Day 21)
- Change in THI Score from Baseline to 1 Year(Baseline and approximately 1 year)
- Change in Hyperacusis Questionnaire (HQ) Score(Baseline, Day 21, Day 51, and 1 year)
- Change in Hospital Anxiety and Depression Scale (HADS) Score(Baseline, Day 21, and Day 51)
研究者
Murat Erinç
Assistant Professor, Department of Audiology
Istanbul Medeniyet University