Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05963542
Other study ID # 2023066-1
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 7, 2023
Est. completion date August 1, 2025

Study information

Verified date March 2024
Source Eye & ENT Hospital of Fudan University
Contact Shan Sun
Phone +86-021-64377134-2033
Email sunshine7896@126.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 164
Est. completion date August 1, 2025
Est. primary completion date August 1, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
ACT for tinnitus
The intervention will be based on the ACT model and adjusted for tinnitus.
Other:
Customized sound therapy
The music will be modulated through a smartphone app using a set program to generate customized tinnitus relieving sound.

Locations

Country Name City State
China Fudan University Eye Ear Nose and Throat Hospital, Otorhinolaryngology Department Shanghai Shanghai

Sponsors (1)

Lead Sponsor Collaborator
Eye & ENT Hospital of Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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 Insomnia Severity Index (ISI) ISI is a self-report questionnaire that assesses the severity and impact of insomnia over the last two weeks. The questionnaire consists of seven items that evaluate the severity of sleep onset, sleep maintenance, early morning awakening problems, sleep dissatisfaction, interference of sleep difficulties with daytime functioning, noticeability of sleep problems by others, and distress caused by sleep difficulties. Each item is scored on a 0-4 scale, and the total score is interpreted as the absence of insomnia (0-7), sub-threshold insomnia (8-14), moderate insomnia (15-21), and severe insomnia (22-28). 2 months from baseline
Secondary Insomnia Severity Index (ISI) ISI is a self-report questionnaire that assesses the severity and impact of insomnia over the last two weeks. The questionnaire consists of seven items that evaluate the severity of sleep onset, sleep maintenance, early morning awakening problems, sleep dissatisfaction, interference of sleep difficulties with daytime functioning, noticeability of sleep problems by others, and distress caused by sleep difficulties. Each item is scored on a 0-4 scale, and the total score is interpreted as the absence of insomnia (0-7), sub-threshold insomnia (8-14), moderate insomnia (15-21), and severe insomnia (22-28). 3 months from baseline
Secondary Insomnia Severity Index (ISI) ISI is a self-report questionnaire that assesses the severity and impact of insomnia over the last two weeks. The questionnaire consists of seven items that evaluate the severity of sleep onset, sleep maintenance, early morning awakening problems, sleep dissatisfaction, interference of sleep difficulties with daytime functioning, noticeability of sleep problems by others, and distress caused by sleep difficulties. Each item is scored on a 0-4 scale, and the total score is interpreted as the absence of insomnia (0-7), sub-threshold insomnia (8-14), moderate insomnia (15-21), and severe insomnia (22-28). 6 months from baseline
Secondary Sleep Onset Latency (SOL) SOL will be estimated with actigraphy. Actigraphy is a small watch worn on the participant's non-dominant wrist that collects objective sleep parameters. Lower score indicates better sleep. 2 months from baseline
Secondary Sleep Onset Latency (SOL) SOL will be estimated with actigraphy. Actigraphy is a small watch worn on the participant's non-dominant wrist that collects objective sleep parameters. Lower score indicates better sleep. 3 months from baseline
Secondary Sleep Onset Latency (SOL) SOL will be estimated with actigraphy. Actigraphy is a small watch worn on the participant's non-dominant wrist that collects objective sleep parameters. Lower score indicates better sleep. 6 months from baseline
Secondary Wake After Sleep Onset (WASO) WASO will be estimated with actigraphy. Actigraphy is a small watch worn on the participant's non-dominant wrist that collects objective sleep parameters. Lower score indicates better sleep. 2 months from baseline
Secondary Wake After Sleep Onset (WASO) WASO will be estimated with actigraphy. Actigraphy is a small watch worn on the participant's non-dominant wrist that collects objective sleep parameters. Lower score indicates better sleep. 3 months from baseline
Secondary Wake After Sleep Onset (WASO) WASO will be estimated with actigraphy. Actigraphy is a small watch worn on the participant's non-dominant wrist that collects objective sleep parameters. Lower score indicates better sleep. 6 months from baseline
Secondary Sleep Efficiency (SE) SE will be estimated with actigraphy. Actigraphy is a small watch worn on the participant's non-dominant wrist that collects objective sleep parameters. Higher score indicates better sleep. 2 months from baseline
Secondary Sleep Efficiency (SE) SE will be estimated with actigraphy. Actigraphy is a small watch worn on the participant's non-dominant wrist that collects objective sleep parameters. Higher score indicates better sleep. 3 months from baseline
Secondary Sleep Efficiency (SE) SE will be estimated with actigraphy. Actigraphy is a small watch worn on the participant's non-dominant wrist that collects objective sleep parameters. Higher score indicates better sleep. 6 months from baseline
Secondary Visual Analogue Scale (VAS) Subjective perception of tinnitus loudness will be assessed using the VAS. Participants will be asked to rate the loudness of the tinnitus on a scale ranging from 0 (no tinnitus) to 10 (tinnitus could not be louder). 2 months from baseline
Secondary Visual Analogue Scale (VAS) Subjective perception of tinnitus loudness will be assessed using the VAS. Participants will be asked to rate the loudness of the tinnitus on a scale ranging from 0 (no tinnitus) to 10 (tinnitus could not be louder). 3 months from baseline
Secondary Visual Analogue Scale (VAS) Subjective perception of tinnitus loudness will be assessed using the VAS. Participants will be asked to rate the loudness of the tinnitus on a scale ranging from 0 (no tinnitus) to 10 (tinnitus could not be louder). 6 months from baseline
Secondary Hospital Anxiety and Distress Scale (HADS) HADS is a 14-item self-report questionnaire with two 7-item subscales to assess symptoms of anxiety (HADS-A) and depression (HADS-D)[31]. Each item is scored from 0-3, with each subscale ranging from 0-21. A threshold value of 8 or greater for the HADS-A or HADS-D indicates clinically significant symptoms of anxiety or depression. 2 months from baseline
Secondary Hospital Anxiety and Distress Scale (HADS) HADS is a 14-item self-report questionnaire with two 7-item subscales to assess symptoms of anxiety (HADS-A) and depression (HADS-D)[31]. Each item is scored from 0-3, with each subscale ranging from 0-21. A threshold value of 8 or greater for the HADS-A or HADS-D indicates clinically significant symptoms of anxiety or depression. 3 months from baseline
Secondary Hospital Anxiety and Distress Scale (HADS) HADS is a 14-item self-report questionnaire with two 7-item subscales to assess symptoms of anxiety (HADS-A) and depression (HADS-D)[31]. Each item is scored from 0-3, with each subscale ranging from 0-21. A threshold value of 8 or greater for the HADS-A or HADS-D indicates clinically significant symptoms of anxiety or depression. 6 months from baseline
Secondary Tinnitus Acceptance Questionnaire (TAQ) TAQ consists of 12 items divided into two factors: activity engagement and tinnitus suppression, and is widely used as a measure of experiential avoidance/acceptance in relation to tinnitus. The total score is 72, with higher scores indicating a higher level of tinnitus-related acceptance. 2 months from baseline
Secondary Tinnitus Acceptance Questionnaire (TAQ) TAQ consists of 12 items divided into two factors: activity engagement and tinnitus suppression, and is widely used as a measure of experiential avoidance/acceptance in relation to tinnitus. The total score is 72, with higher scores indicating a higher level of tinnitus-related acceptance. 3 months from baseline
Secondary Tinnitus Acceptance Questionnaire (TAQ) TAQ consists of 12 items divided into two factors: activity engagement and tinnitus suppression, and is widely used as a measure of experiential avoidance/acceptance in relation to tinnitus. The total score is 72, with higher scores indicating a higher level of tinnitus-related acceptance. 6 months from baseline
See also
  Status Clinical Trial Phase
Completed NCT04512768 - Treating Comorbid Insomnia in Transdiagnostic Internet-Delivered Cognitive Behaviour Therapy N/A
Completed NCT06339853 - Study of Efficacy of Digital Cognitive Behavioral Therapy With Wearable Device for Insomnia N/A
Recruiting NCT04069247 - Effectiveness of eCBT-I on Improving Mental Health in Chinese Youths With Insomnia N/A
Completed NCT04493593 - Internet-delivered CBT-I (Space for Sleep): Pilot and Feasibility N/A
Recruiting NCT05956886 - Sleep Chatbot Intervention for Emerging Black/African American Adults N/A
Recruiting NCT06278077 - Neurexan - a Clinical Trial in Short-Term Insomnia Patients Phase 2
Completed NCT04661306 - The Better Sleep for Supporters With Insomnia Study N/A
Recruiting NCT06207279 - Preliminary Study on the Development and Reliability and Validity of Attention Rating Scale
Recruiting NCT06006299 - Investigating the Use of taVNS to Treat Insomnia in Individuals With Breast Cancer (taVNS-insomnia-BC) N/A
Completed NCT03683381 - App-based Intervention for Treating Insomnia Among Patients With Epilepsy N/A
Completed NCT04564807 - Testing an Online Insomnia Intervention N/A
Completed NCT03673397 - The Acute Effect of Aerobic Exercise on Sleep in Patients With Depression N/A
Completed NCT04035200 - Safety, Tolerability and Efficacy Study of V117957 in Subjects With Insomnia Associated With Alcohol Cessation Phase 2
Active, not recruiting NCT05027438 - Reducing Use of Sleep Medications Assisted by a Digital Insomnia Intervention N/A
Recruiting NCT06053840 - An Open-label Trial to Evaluate the Safety and Efficacy of Chloral Hydrate in Patients With Severe Insomnia Phase 4
Not yet recruiting NCT06348082 - Project Women's Insomnia Sleep Health Equity Study (WISHES) N/A
Not yet recruiting NCT06363799 - Osteopathic Protocol for Insomnia in College Students N/A
Not yet recruiting NCT06025968 - Digital Cognitive-behavioral Therapy for Insomnia for Patients With Multiple Sclerosis N/A
Not yet recruiting NCT05991492 - Improving Sleep With a Digital Cognitive Behavioral Therapy for Insomnia Application N/A
Not yet recruiting NCT03194191 - Pregnancy With Insomnia: a Trial of Acupuncture N/A