Clinical trial NCT05963542: Efficacy of Online Acceptance and Commitment Therapy and Sound Therapy for Patients With Tinnitus and Insomnia
Official title: SoundMind Trial: a Randomized Controlled Trial of Online Acceptance and Commitment Therapy and Sound Therapy for Tinnitus
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Tinnitus
Insomnia
Lead sponsor: Eye & ENT Hospital of Fudan University
Sponsor class: OTHER
First posted: 2023-07-27
Enrollment: 164
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 quality of life of patients and represent a huge burden to society. While interventions exist to alleviate tinnitus distress, they often do not address sleep disturbances in tinnitus patients. Patients affected by tinnitus and insomnia suffer from long-term functional and psychological problems. Sound therapy is widely used to treat tinnitus, often combined with education and counseling, and can effectively improve the quality of life. In addition, acceptance and commitment therapy (ACT) for tinnitus improves both tinnitus and sleep. However, there is a lack of evidence on the effects of combining ACT with sound therapy for tinnitus-related insomnia patients.

To fully characterize tinnitus patients, standardized measures of tinnitus and insomnia are essential. These measures include pure tone audiometry (PTA), acoustic immittance (AI), tinnitus pitch matching (PM) and loudness matching (LM), minimum masking level (MML), tinnitus handicap inventory (THI), insomnia severity index (ISI), and hospital anxiety and depression scale (HADS).

Investigators hypothesize that the combination of ACT and sound therapy will be superiority to sound therapy alone in reducing tinnitus distress.

Eligibility criteria: Inclusion Criteria:

1. Adults aged between 18 and 80 years old.
2. Experiencing subjective tinnitus for at least 3 months.
3. A score of 38 or more on THI.
4. A score of 15 or more on ISI.
5. 55 dB HL or less on the average pure tone threshold (0.5, 1, 2kHz) of the worse ear.
6. Ability to read and write in Chinese and use a smartphone with an internet connection to work with text material.

Exclusion Criteria:

1. Pulsatile tinnitus and objective tinnitus.
2. Organic sleep disorders.
3. Other diseases that need to be treated first (e.g., infections, tumors, otosclerosis, Meniere's disease, the acute stage of sudden sensorineural hearing loss).
4. Severe mental illness.
5. Undergoing other research that may affect tinnitus and sleep.

Primary outcomes:
measure: Tinnitus Handicap Inventory (THI)
timeFrame: 2 months from baseline
measure: Tinnitus Handicap Inventory (THI)
timeFrame: 3 months from baseline
measure: Tinnitus Handicap Inventory (THI)
timeFrame: 6 months from baseline
Secondary outcomes:
measure: Insomnia Severity Index (ISI)
timeFrame: 2 months from baseline
measure: Insomnia Severity Index (ISI)
timeFrame: 3 months from baseline
measure: Insomnia Severity Index (ISI)
timeFrame: 6 months from baseline
measure: Sleep Onset Latency (SOL)
timeFrame: 2 months from baseline
measure: Sleep Onset Latency (SOL)
timeFrame: 3 months from baseline
measure: Sleep Onset Latency (SOL)
timeFrame: 6 months from baseline
measure: Wake After Sleep Onset (WASO)
timeFrame: 2 months from baseline
measure: Wake After Sleep Onset (WASO)
timeFrame: 3 months from baseline
measure: Wake After Sleep Onset (WASO)
timeFrame: 6 months from baseline
measure: Sleep Efficiency (SE)
timeFrame: 2 months from baseline
measure: Sleep Efficiency (SE)
timeFrame: 3 months from baseline
measure: Sleep Efficiency (SE)
timeFrame: 6 months from baseline
measure: Visual Analogue Scale (VAS)
timeFrame: 2 months from baseline
measure: Visual Analogue Scale (VAS)
timeFrame: 3 months from baseline
measure: Visual Analogue Scale (VAS)
timeFrame: 6 months from baseline
measure: Hospital Anxiety and Distress Scale (HADS)
timeFrame: 2 months from baseline
measure: Hospital Anxiety and Distress Scale (HADS)
timeFrame: 3 months from baseline
measure: Hospital Anxiety and Distress Scale (HADS)
timeFrame: 6 months from baseline
measure: Tinnitus Acceptance Questionnaire (TAQ)
timeFrame: 2 months from baseline
measure: Tinnitus Acceptance Questionnaire (TAQ)
timeFrame: 3 months from baseline
measure: Tinnitus Acceptance Questionnaire (TAQ)
timeFrame: 6 months from baseline
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University Eye Ear Nose and Throat Hospital, Otorhinolaryngology Department
state: Shanghai
Study officials:
affiliation: Eye and ENT Hospital of Fudan University
name: Huawei Li
role: PRINCIPAL_INVESTIGATOR
References: