About this trial
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.
Eligibility criteria
Qualifiers
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;
Disqualifiers
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;
Trial design
Treatments tested in this trial
- Internet-based Cognitive Behavioral Therapy for Insomnia (CBT-I)
- Online Patient Education