NCT05963542

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 single-blind, 6-months randomized, controlled trial with two parallel groups. One is the ACT + sound therapy group, and the other is the sound therapy group.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
164

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 16, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 27, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

September 7, 2023

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2025

Completed
Last Updated

March 13, 2024

Status Verified

March 1, 2024

Enrollment Period

1.9 years

First QC Date

July 16, 2023

Last Update Submit

March 11, 2024

Conditions

TinnitusInsomnia

Outcome Measures

Primary Outcomes (3)

  • Tinnitus Handicap Inventory (THI)

    The THI questionnaire, widely used in research, including functional, emotional, and catastrophic subscales. It consists of 25 questions, and answers are rated on a "yes" (4 points), "sometimes" (2 points), and "no" (0 points) scale. The total score is calculated by adding up the scores for all questions and classifying the severity of tinnitus as no handicap (0-16), mild handicap (18-36), moderate handicap (38-56), and severe handicap (58-100).

    2 months from baseline

  • Tinnitus Handicap Inventory (THI)

    The THI questionnaire, widely used in research, including functional, emotional, and catastrophic subscales. It consists of 25 questions, and answers are rated on a "yes" (4 points), "sometimes" (2 points), and "no" (0 points) scale. The total score is calculated by adding up the scores for all questions and classifying the severity of tinnitus as no handicap (0-16), mild handicap (18-36), moderate handicap (38-56), and severe handicap (58-100).

    3 months from baseline

  • Tinnitus Handicap Inventory (THI)

    The THI questionnaire, widely used in research, including functional, emotional, and catastrophic subscales. It consists of 25 questions, and answers are rated on a "yes" (4 points), "sometimes" (2 points), and "no" (0 points) scale. The total score is calculated by adding up the scores for all questions and classifying the severity of tinnitus as no handicap (0-16), mild handicap (18-36), moderate handicap (38-56), and severe handicap (58-100).

    6 months from baseline

Secondary Outcomes (21)

  • Insomnia Severity Index (ISI)

    2 months from baseline

  • Insomnia Severity Index (ISI)

    3 months from baseline

  • Insomnia Severity Index (ISI)

    6 months from baseline

  • Sleep Onset Latency (SOL)

    2 months from baseline

  • Sleep Onset Latency (SOL)

    3 months from baseline

  • +16 more secondary outcomes

Study Arms (2)

ACT + sound therapy group

EXPERIMENTAL

The combined treatment group will receive Internet-delivered guided self-help tinnitus treatment based on ACT combined with customized sound therapy. The online ACT program includes 8 modules of structured self-help material over 8 weeks. Each module includes information, exercises, and homework. The self-help material covers the six core processes of ACT: acceptance, cognitive defusion, being present, self-as-context, values, and committed action, emphasizing psychological flexibility. Customized sound therapy will be provided by the Fudan Tinnitus Relieving System (FTRS) app. Participants will listen to tailor-made music through the app for more than two hours per day.

Behavioral: ACT for tinnitusOther: Customized sound therapy

sound therapy group

ACTIVE COMPARATOR

The single treatment group will receive customized sound therapy provided by the FTRS app for more than two hours per day.

Other: Customized sound therapy

Interventions

ACT for tinnitusBEHAVIORAL

The intervention will be based on the ACT model and adjusted for tinnitus.

ACT + sound therapy group
Customized sound therapyOTHER

The music will be modulated through a smartphone app using a set program to generate customized tinnitus relieving sound.

ACT + sound therapy groupsound therapy group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fudan University Eye Ear Nose and Throat Hospital, Otorhinolaryngology Department

Shanghai, Shanghai Municipality, 200031, China

RECRUITING

Related Publications (1)

  • Huang X, Tang D, Sun S, Li H. SoundMind Trial: a study protocol for a randomised controlled trial for online acceptance and commitment therapy and sound therapy for tinnitus. BMJ Open. 2024 Oct 17;14(10):e080863. doi: 10.1136/bmjopen-2023-080863.

    PMID: 39419615DERIVED

MeSH Terms

Conditions

TinnitusSleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Hearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersMental Disorders

Study Officials

  • Huawei Li

    Eye and ENT Hospital of Fudan University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Shan Sun

CONTACT

+86-021-64377134-2033sunshine7896@126.com

Dongmei Tang

CONTACT

+86-13023299189tang.dongm@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 16, 2023

First Posted

July 27, 2023

Study Start

September 7, 2023

Primary Completion

August 1, 2025

Study Completion

August 1, 2025

Last Updated

March 13, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)