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
This trial does not accept healthy volunteersQualifiers
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
Parallel
Treatments tested in this trial
Internet-based Cognitive Behavioral Therapy for Insomnia (CBT-I)
Other interventionThe 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 interventionThe 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.
Treatment groups
Trial outcomes
Primary outcomes
Tinnitus Handicap Inventory (THI)
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.
Secondary outcomes
Insomnia Severity Index (ISI)
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.
Sleep Onset Latency (SOL)
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.
Wake Time After Sleep Onset (WASO)
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.
Total Sleep Time (TST)
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.
Sponsors and contacts
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