Status:
RECRUITING
Efficacy of Online Acceptance and Commitment Therapy and Sound Therapy for Patients With Tinnitus and Insomnia
Lead Sponsor:
Eye & ENT Hospital of Fudan University
Conditions:
Tinnitus
Insomnia
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
Considering the lack of evidence on the effects of combining acceptance and commitment therapy (ACT) with customized sound therapy for tinnitus-related insomnia patients, investigators designed this s...
Detailed Description
Insomnia is one of the most frequent and severe comorbidities in patients with tinnitus and is highly relevant for the perceived tinnitus severity. Both tinnitus and insomnia significantly affect the ...
Eligibility Criteria
Inclusion
- Adults aged between 18 and 80 years old.
- Experiencing subjective tinnitus for at least 3 months.
- A score of 38 or more on THI.
- A score of 15 or more on ISI.
- 55 dB HL or less on the average pure tone threshold (0.5, 1, 2kHz) of the worse ear.
- Ability to read and write in Chinese and use a smartphone with an internet connection to work with text material.
Exclusion
- Pulsatile tinnitus and objective tinnitus.
- Organic sleep disorders.
- Other diseases that need to be treated first (e.g., infections, tumors, otosclerosis, Meniere's disease, the acute stage of sudden sensorineural hearing loss).
- Severe mental illness.
- Undergoing other research that may affect tinnitus and sleep.
Key Trial Info
Start Date :
September 7 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2025
Estimated Enrollment :
164 Patients enrolled
Trial Details
Trial ID
NCT05963542
Start Date
September 7 2023
End Date
August 1 2025
Last Update
March 13 2024
Active Locations (1)
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1
Fudan University Eye Ear Nose and Throat Hospital, Otorhinolaryngology Department
Shanghai, Shanghai Municipality, China, 200031