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

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.

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.