Esta página foi traduzida automaticamente e a precisão da tradução não é garantida. Por favor, consulte o versão em inglês para um texto fonte.

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

13 de agosto de 2026 atualizado 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.

Visão geral do estudo

Status

Ainda não está recrutando

Condições

Intervenção / Tratamento

Descrição detalhada

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 estudo

Intervencional

Inscrição (Estimado)

168

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Locais de estudo

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

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Descrição

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.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Solteiro

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
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.
Outro: 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 Ativo: 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.
Outro: 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.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Tinnitus Handicap Inventory (THI)
Prazo: 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 resultados secundários

Medida de resultado
Descrição da medida
Prazo
Insomnia Severity Index (ISI)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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%)
Prazo: 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
Prazo: 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)
Prazo: 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)
Prazo: 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

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Eye & ENT Hospital of Fudan University

Investigadores

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

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

24 de agosto de 2026

Conclusão Primária (Estimado)

30 de dezembro de 2029

Conclusão do estudo (Estimado)

30 de dezembro de 2029

Datas de inscrição no estudo

Enviado pela primeira vez

13 de agosto de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

13 de agosto de 2026

Primeira postagem (Real)

18 de agosto de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

18 de agosto de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

13 de agosto de 2026

Última verificação

1 de agosto de 2026

Mais Informações

Termos relacionados a este estudo

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • 2025263

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

INDECISO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

Se inscrever