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Effectiveness of Sound Therapy Combined with Cognitive Behavioral Therapy for Insomnia or Acceptance and Commitment Therapy in The Treatment of Tinnitus

Effectiveness of Sound Therapy Combined with Cognitive Behavioral Therapy for Insomnia or Acceptance and Commitment Therapy in The Treatment of Tinnitus

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300074740
Enrollment
Unknown
Registered
2023-08-15
Start date
2023-08-10
Completion date
Unknown
Last updated
2023-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tinnitus

Interventions

Sound therapy combined with cognitive behavioral therapy for insomnia group:Listening to the treatment sound at least 2 hours a day in total and receiving Internet-based cognitive behavioral therapy f
Sound therapy combined with acceptance and commitment therapy for tinnitus group:Listening to the treatment sound at least 2 hours a day in total and receiving Internet-based acceptance and commitment

Sponsors

Eye & ENT Hospital of Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Adults aged between 18 and 80 years old. 2. Chronic subjective tinnitus with a Tinnitus Handicap Impairment Questionnaire (THI) score of =38, lasting =3 months. 3. Insomnia Severity Index (ISI) score >14. 4. 55 dB HL or less on the average pure tone threshold (0.5,1,2kHz) of the worse ear. 5. Has the ability to read and write in Chinese to work with text material, use a smartphone with a connection to the Internet, and be willing to sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. Pulsatile tinnitus and objective tinnitus. 2. Severe hyperacusis. 3. Otosclerosis, Ménière’s disease, sudden deafness, etc. 4. Organic sleep disorders (obstructive sleep apnea syndrome, etc.) 5. Severe mental illness. 6. Pregnant and lactating women. 7. Combination of serious cardiovascular or other organ disease, unable to participate in the experiment or cooperate with the follow-up visit. 8. Undergoing other research that may affect tinnitus and sleep. 9. Subjects who are not considered suitable for this clinical trial by the researchers.

Design outcomes

Primary

MeasureTime frame
Tinnitus Handicapped Inventory (THI);—

Secondary

MeasureTime frame
Hospital Anxiety and Distress Scale (HADS);Insomnia Severity Index (ISI);Sleep Parameters ;Visual Analogue Scale (VAS);Tinnitus Acceptance Questionnaire (TAQ);Dysfunctional Beliefs and Attitudes About Sleep (DBAS-16); Epworth Sleepiness Scale (ESS);—

Countries

China

Contacts

Public ContactLi Huawei

Eye & ENT Hospital of Fudan University

hwli@shmu.edu.cn+86 189 1778 5659

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026