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

NCT07769515 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 168

Last updated 2026-08-18

No results posted yet for this study

Summary

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.

Conditions

Interventions

OTHER

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.

OTHER

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.

Sponsors & Collaborators

  • Eye & ENT Hospital of Fudan University

    lead OTHER

Principal Investigators

  • Huawei Li, Ph.D · Eye and ENT Hospital of Fudan University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-24
Primary Completion
2029-12-30
Completion
2029-12-30

Countries

  • China

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07769515 on ClinicalTrials.gov