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

Sponsor
Eye & ENT Hospital of Fudan University
Study ID
NCT07769515
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Internet-based Cognitive Behavioral Therapy for Insomnia (CBT-I) — OTHER
    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.
  • Online Patient Education — OTHER
    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.

Study Details

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.

Key Dates

First listed
Aug 18, 2026
Start date
Aug 24, 2026
Status verified
Aug 2026
Primary completion
Dec 30, 2029
Completion
Dec 30, 2029

Study Design

Enrollment
168 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.
  • Active Comparator: 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.

Primary Outcome Measure

Tinnitus Handicap Inventory (THI) [ Time Frame: 1 month, 2 months, 3 months, and 5 month from baseline ]

Central Contacts

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