Efficacy of Internet-based Cognitive Behavioral Therapy for Insomnia in Patients With Tinnitus and Insomnia
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Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 65 years old?
Source: NCT07769515, who can take part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Eye & ENT Hospital of Fudan University
- Trial code
- NCT07769515
- Record updated
- 18 August 2026
- Original description
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.Read full original descriptionShow less
A Randomized Controlled Trial of Internet-based Cognitive Behavioral Therapy for Insomnia Versus Patient Education in Patients With Tinnitus and Insomnia
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.
Inclusion: 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: Concurrent enrollment in another clinical trial targeting tinnitus or insomnia; 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; Objective or pulsatile tinnitus.