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Набор скоро начнётся NCT07665385

Trial of Management of Chronic Tinnitus by Sound Therapy and Cognitive Behavioral Therapy

Без фазы С лечением Chronic Subjective Tinnitus

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Group A: sound therapy, Group B: Cognitive Behavioral Therapy, Group C: Combined CBT + Sound Therapy.
Кому может быть актуально
Состояния в реестре: Chronic Subjective Tinnitus. Базовые параметры: 18 мес. — 65 мес. · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Египет
Следующий шаг
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Официальное название

Efficacy of Sound Therapy, Cognitive Behavioral Therapy and Their Combination in Management of Chronic Tinnitus

Обзор

clinical trial: The main aim of this study is to compare the effectiveness of Cognitive Behavioral Therapy (CBT) and Sound Therapy, both individually and in combination, in the management of patients with chronic subjective tinnitus and to evaluate their impact on decreasing tinnitus severity, psychological wellbeing and quality of life. Patients will be randomly divided into three groups: * Group A: patients will receive Sound Therapy. * Group B: patients will receive Cognitive Behavioral Therapy (CBT). * Group C: patients will receive Combined CBT + Sound Therapy.

Подробное описание

Because of the multifactorial nature of tinnitus, its effective management requires a multidisciplinary approach. While there is no single pullet mechanism of cure, current treatment strategies primary focus on reducing tinnitus related perception and minimizing its associated distress through auditory and psychological interventions.

Among these approaches, is the Sound Therapy which aims to decrease the contrast between tinnitus and related neural activity by introducing external sounds, which facilitates habituation and reducing tinnitus perception .

In contrast, Cognitive Behavioral Therapy (CBT) targets the patient's cognitive and emotional reaction to tinnitus by modifying maladaptive thoughts and behaviors, there by improving coping strategies and reducing tinnitus-related distress (Andersson, 2011). Recent evidence suggests that combining both modalities may provide superior outcomes compared to either approach alone, highlighting the potential value for integrated treatment strategies in tinnitus management (Hall et

Вмешательства

  • Поведенческое Group A: sound therapy
    Group A: Sound Therapy * Patients will receive individualized sound therapy using broadband noise or tinnitus maskers. * Daily use recommended for 2-4 hours/day. * Duration: 6 weeks. * Patient will be instructed on habituation-based listening techniques
  • Поведенческое Group B: Cognitive Behavioral Therapy
    Group B: Cognitive Behavioral Therapy (CBT) • Structured CBT program consisting of 6 sessions over 6 weeks. Each session categorization: * Psychoeducation about tinnitus * Cognitive restructuring of negative thoughts * Relaxation techniques (breathing exercises, muscle relaxation) * Attention diversion strategies * Sleep hygiene education
  • Поведенческое Group C: Combined CBT + Sound Therapy
    Group C: Combined Therapy • Patients will receive both sound therapy and CBT simultaneously following the same protocol as above.

Первичные конечные точки

  • Primary outcome: Changes in tinnitus severity [Срок оценки: Baseline, immediately after completion of treatment , and 3 months after completion of treatment]
Вторичные конечные точки (2)
  • chang in Visual Analog Scale (VAS) score [Срок оценки: Baseline, immediately after completion of treatment , and 3 months after completion of treatment]
  • change in Tinnitus Handicap Inventory (THI) score [Срок оценки: Baseline, immediately after completion of treatment , and 3 months after completion of treatment]

Критерии участия

Критерии включения

  • o Age: 18-65 years.
  • Hearing level: Patients with normal hearing or mild to moderate sensorineural hearing loss (to ensure homogeneity of the sample) (National Institute for Health and Care Excellence, 2020)
  • Complaint: patients with chronic subjective tinnitus (> 3 months).
  • Psychological state: Patients with stable general and psychological condition.

Критерии исключения

  • o Age: <18, >65 years
  • Hearing level: Patients with severe hearing loss not suitable for sound therapy
  • Complaint: Objective tinnitus (vascular or muscular origin)
  • Psychological state: Patients with active psychiatric disorders requiring immediate intervention.
  • Active middle or external ear disease

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Лечение

Центры проведения

Египет · 1 центр
  • Sohag faculty of medicine — Sohag

Идентификаторы

NCT: NCT07665385 · Soh-Med-26-5-8MS

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗