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Efficacy of Internet-based Cognitive Behavioral Therapy for Insomnia in Patients With Tinnitus and Insomnia

13 de agosto de 2026 actualizado por: Eye & ENT Hospital of Fudan University

A Randomized Controlled Trial of Internet-based Cognitive Behavioral Therapy for Insomnia Versus Patient Education in Patients With Tinnitus and Insomnia

This single-center, single-blind, randomized controlled trial is designed to evaluate the efficacy of therapist-guided, internet-based cognitive behavioral therapy for insomnia (CBT-I) compared with patient education in patients with chronic subjective tinnitus and clinically significant insomnia. A total of 168 participants will be randomized in a 1:1 ratio to receive either an 8-week internet-based CBT-I intervention or an online patient education intervention. The primary outcome is the between-group mean difference in Tinnitus Handicap Inventory (THI) score at 2 months after randomization. Secondary outcomes include insomnia severity, subjective sleep parameters, tinnitus loudness, anxiety and depression symptoms, and dysfunctional beliefs and attitudes about sleep. Participants will be assessed at baseline, 1 month, 2 months, 3 months, and 5 months.

Descripción general del estudio

Estado

Aún no reclutando

Condiciones

Intervención / Tratamiento

Descripción detallada

Insomnia is one of the most common comorbidities in patients with chronic tinnitus and is closely associated with tinnitus-related distress and impaired quality of life. Although CBT-I is an established treatment for insomnia, access to conventional face-to-face CBT-I may be limited by the availability of trained therapists, geographic barriers, and time constraints.

This study is designed to evaluate whether therapist-guided, internet-based CBT-I can improve tinnitus-related distress and sleep-related outcomes in patients with chronic subjective tinnitus and clinically significant insomnia.

Eligible participants will be recruited at the Eye & ENT Hospital of Fudan University and randomly assigned in a 1:1 ratio to either the internet-based CBT-I group or the patient education group. Both interventions will be delivered through smartphone-based platforms over an 8-week period.

The CBT-I intervention consists of eight weekly modules incorporating stimulus control, sleep restriction therapy, cognitive restructuring, relaxation and mindfulness practices, and sleep hygiene education. Participants will complete daily relaxation exercises and weekly homework assignments, with treatment progress monitored by trained therapists through the online platform.

The patient education group will receive a non-individualized online education package covering general information about tinnitus and insomnia, their potential interaction, and general recommendations for sleep and lifestyle management. The educational materials will remain accessible throughout the intervention period without therapist involvement.

The study will follow the intention-to-treat principle. Longitudinal outcomes will be analyzed using mixed-effects models incorporating treatment group, time, and treatment-by-time interaction.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

168

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

  • Nombre: Xiaoling Huang, MS
  • Número de teléfono: +86-15800955305
  • Correo electrónico: xiaolingh2023@163.com

Ubicaciones de estudio

  • Porcelana
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, Porcelana, 200031
        • Fudan University Eye Ear Nose and Throat Hospital, Otorhinolaryngology Department
        • Contacto:

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Descripción

Inclusion Criteria:

  • Adults aged between 18 and 65 years;
  • Diagnosis of chronic subjective tinnitus persisting for at least 6 months;
  • A score of 38 or higher on the Tinnitus Handicap Inventory (THI);
  • An Insomnia Severity Index (ISI) score of 8 or higher;
  • Ability to understand the study procedures and provide informed consent;
  • Proficiency in reading and writing Chinese;
  • Access to a smartphone for participation in the digital intervention.

Exclusion Criteria:

  • Objective or pulsatile tinnitus;
  • Specific otologic conditions requiring immediate medical treatment, such as sudden sensorineural hearing loss;
  • Diagnosed organic sleep disorders, such as obstructive sleep apnea;
  • Serious psychiatric disorders, including schizophrenia;
  • Concurrent enrollment in another clinical trial targeting tinnitus or insomnia.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Internet-based CBT-I Group
Participants randomized to the experimental arm will receive an 8-week therapist-guided, internet-based cognitive behavioral therapy for insomnia (CBT-I) program. The intervention is designed to improve insomnia symptoms and will be delivered through a smartphone-based online platform. Participants will complete weekly CBT-I modules and related homework assignments during the 8-week intervention period, with follow-up assessments conducted after the intervention.
Otro: Internet-based Cognitive Behavioral Therapy for Insomnia (CBT-I)
The internet-based CBT-I intervention will be delivered over 8 weeks through a smartphone-based online platform. The program consists of eight weekly modules incorporating core components of CBT-I, including stimulus control, sleep restriction therapy, cognitive restructuring, relaxation and mindfulness practices, and sleep hygiene education. Participants will complete daily relaxation exercises and weekly homework assignments. Treatment progress will be monitored through the online platform, and trained therapists will review participants' progress and provide feedback during the intervention period.
Comparador activo: Patient Education Group
Participants randomized to the comparator arm will receive an 8-week online patient education intervention. The intervention provides general educational information about tinnitus, insomnia, their potential relationship, and general recommendations for sleep and lifestyle management. Participants will have access to the educational materials throughout the 8-week intervention period.
Otro: Online Patient Education
The online patient education intervention will provide non-individualized educational materials covering tinnitus and insomnia, their potential interaction, and general strategies for sleep and lifestyle management. The educational materials will be delivered through a smartphone-based online platform and will remain accessible throughout the 8-week intervention period.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Tinnitus Handicap Inventory (THI)
Periodo de tiempo: 1 month, 2 months, 3 months, and 5 month from baseline
The Tinnitus Handicap Inventory (THI) is a 25-item self-report questionnaire assessing the functional, emotional, and catastrophic impact of tinnitus. Each item is scored as "yes" (4 points), "sometimes" (2 points), or "no" (0 points), with higher total scores indicating greater tinnitus-related impairment.
1 month, 2 months, 3 months, and 5 month from baseline

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Insomnia Severity Index (ISI)
Periodo de tiempo: 1 month, 2 months, 3 months, and 5 month from baseline
The Insomnia Severity Index (ISI) is a 7-item self-report questionnaire assessing the severity and impact of insomnia during the preceding two weeks. It evaluates sleep initiation and maintenance difficulties, early morning awakening, dissatisfaction with sleep, daytime impairment, noticeability of sleep problems, and distress associated with sleep difficulties.
1 month, 2 months, 3 months, and 5 month from baseline
Sleep Onset Latency (SOL)
Periodo de tiempo: Baseline and during the 8-week intervention period
Sleep onset latency (SOL) will be assessed using a daily sleep diary. SOL is defined as the amount of time required to fall asleep after going to bed. Weekly average SOL will be calculated for outcome analysis.
Baseline and during the 8-week intervention period
Wake Time After Sleep Onset (WASO)
Periodo de tiempo: Baseline and during the 8-week intervention period
Wake time after sleep onset (WASO) will be assessed using a daily sleep diary. WASO is defined as the total amount of time spent awake after initially falling asleep and before final awakening. Weekly average WASO will be calculated for outcome analysis.
Baseline and during the 8-week intervention period
Total Sleep Time (TST)
Periodo de tiempo: Baseline and during the 8-week intervention period
Total sleep time (TST) will be assessed using a daily sleep diary. TST is defined as the total amount of time spent asleep during the sleep period. Weekly average TST will be calculated for outcome analysis.
Baseline and during the 8-week intervention period
Sleep Efficiency (SE%)
Periodo de tiempo: Baseline and during the 8-week intervention period
Sleep efficiency (SE%) will be assessed using a daily sleep diary and calculated as the percentage of time spent asleep relative to time spent in bed. Weekly average sleep efficiency will be calculated for outcome analysis.
Baseline and during the 8-week intervention period
Visual Analogue Scale (VAS) for Tinnitus Loudness
Periodo de tiempo: 1 month, 2 months, 3 months, and 5 month from baseline
Subjective tinnitus loudness will be assessed using a 10-cm visual analogue scale ranging from 0 ("no tinnitus") to 10 ("extremely loud tinnitus").
1 month, 2 months, 3 months, and 5 month from baseline
Hospital Anxiety and Depression Scale (HADS)
Periodo de tiempo: 1 month, 2 months, 3 months, and 5 month from baseline
The Hospital Anxiety and Depression Scale (HADS) is a 14-item self-report questionnaire comprising two subscales: HADS-Anxiety (HADS-A) and HADS-Depression (HADS-D). Each subscale contains seven items scored from 0 to 3, with scores ranging from 0 to 21.
1 month, 2 months, 3 months, and 5 month from baseline
Dysfunctional Beliefs and Attitudes About Sleep Scale (DBAS)
Periodo de tiempo: 1 month, 2 months, 3 months, and 5 month from baseline
The Dysfunctional Beliefs and Attitudes About Sleep Scale (DBAS) assesses maladaptive beliefs and attitudes regarding sleep, including rigid beliefs about required sleep duration, misconceptions regarding insomnia, and excessive concern about sleep. Higher scores indicate greater endorsement of dysfunctional sleep-related cognitions.
1 month, 2 months, 3 months, and 5 month from baseline

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Eye & ENT Hospital of Fudan University

Investigadores

  • Investigador principal: Huawei Li, Ph.D, Eye and ENT Hospital of Fudan University

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

24 de agosto de 2026

Finalización primaria (Estimado)

30 de diciembre de 2029

Finalización del estudio (Estimado)

30 de diciembre de 2029

Fechas de registro del estudio

Enviado por primera vez

13 de agosto de 2026

Primero enviado que cumplió con los criterios de control de calidad

13 de agosto de 2026

Publicado por primera vez (Actual)

18 de agosto de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

18 de agosto de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

13 de agosto de 2026

Última verificación

1 de agosto de 2026

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • 2025263

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

INDECISO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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