Efficacy of Internet-based Cognitive Behavioral Therapy for Insomnia in Patients With Tinnitus and Insomnia
2026년 8월 13일 업데이트: Eye & ENT Hospital of Fudan University
A Randomized Controlled Trial of Internet-based Cognitive Behavioral Therapy for Insomnia Versus Patient Education in Patients With Tinnitus and Insomnia
This single-center, single-blind, randomized controlled trial is designed to evaluate the efficacy of therapist-guided, internet-based cognitive behavioral therapy for insomnia (CBT-I) compared with patient education in patients with chronic subjective tinnitus and clinically significant insomnia.
A total of 168 participants will be randomized in a 1:1 ratio to receive either an 8-week internet-based CBT-I intervention or an online patient education intervention.
The primary outcome is the between-group mean difference in Tinnitus Handicap Inventory (THI) score at 2 months after randomization.
Secondary outcomes include insomnia severity, subjective sleep parameters, tinnitus loudness, anxiety and depression symptoms, and dysfunctional beliefs and attitudes about sleep.
Participants will be assessed at baseline, 1 month, 2 months, 3 months, and 5 months.
연구 개요
상태
아직 모집하지 않음
상세 설명
Insomnia is one of the most common comorbidities in patients with chronic tinnitus and is closely associated with tinnitus-related distress and impaired quality of life. Although CBT-I is an established treatment for insomnia, access to conventional face-to-face CBT-I may be limited by the availability of trained therapists, geographic barriers, and time constraints.
This study is designed to evaluate whether therapist-guided, internet-based CBT-I can improve tinnitus-related distress and sleep-related outcomes in patients with chronic subjective tinnitus and clinically significant insomnia.
Eligible participants will be recruited at the Eye & ENT Hospital of Fudan University and randomly assigned in a 1:1 ratio to either the internet-based CBT-I group or the patient education group. Both interventions will be delivered through smartphone-based platforms over an 8-week period.
The CBT-I intervention consists of eight weekly modules incorporating stimulus control, sleep restriction therapy, cognitive restructuring, relaxation and mindfulness practices, and sleep hygiene education. Participants will complete daily relaxation exercises and weekly homework assignments, with treatment progress monitored by trained therapists through the online platform.
The patient education group will receive a non-individualized online education package covering general information about tinnitus and insomnia, their potential interaction, and general recommendations for sleep and lifestyle management. The educational materials will remain accessible throughout the intervention period without therapist involvement.
The study will follow the intention-to-treat principle. Longitudinal outcomes will be analyzed using mixed-effects models incorporating treatment group, time, and treatment-by-time interaction.
연구 유형
중재적
등록 (추정된)
168
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Xiaoling Huang, MS
- 전화번호: +86-15800955305
- 이메일: xiaolingh2023@163.com
연구 장소
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Shanghai Municipality
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Shanghai, Shanghai Municipality, 중국, 200031
- Fudan University Eye Ear Nose and Throat Hospital, Otorhinolaryngology Department
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연락하다:
- Xiaoling Huang, MS
- 전화번호: +86-15800955305
- 이메일: xiaolingh2023@163.com
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
Inclusion Criteria:
- Adults aged between 18 and 65 years;
- Diagnosis of chronic subjective tinnitus persisting for at least 6 months;
- A score of 38 or higher on the Tinnitus Handicap Inventory (THI);
- An Insomnia Severity Index (ISI) score of 8 or higher;
- Ability to understand the study procedures and provide informed consent;
- Proficiency in reading and writing Chinese;
- Access to a smartphone for participation in the digital intervention.
Exclusion Criteria:
- Objective or pulsatile tinnitus;
- Specific otologic conditions requiring immediate medical treatment, such as sudden sensorineural hearing loss;
- Diagnosed organic sleep disorders, such as obstructive sleep apnea;
- Serious psychiatric disorders, including schizophrenia;
- Concurrent enrollment in another clinical trial targeting tinnitus or insomnia.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Internet-based CBT-I Group
Participants randomized to the experimental arm will receive an 8-week therapist-guided, internet-based cognitive behavioral therapy for insomnia (CBT-I) program.
The intervention is designed to improve insomnia symptoms and will be delivered through a smartphone-based online platform.
Participants will complete weekly CBT-I modules and related homework assignments during the 8-week intervention period, with follow-up assessments conducted after the intervention.
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The internet-based CBT-I intervention will be delivered over 8 weeks through a smartphone-based online platform.
The program consists of eight weekly modules incorporating core components of CBT-I, including stimulus control, sleep restriction therapy, cognitive restructuring, relaxation and mindfulness practices, and sleep hygiene education.
Participants will complete daily relaxation exercises and weekly homework assignments.
Treatment progress will be monitored through the online platform, and trained therapists will review participants' progress and provide feedback during the intervention period.
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활성 비교기: Patient Education Group
Participants randomized to the comparator arm will receive an 8-week online patient education intervention.
The intervention provides general educational information about tinnitus, insomnia, their potential relationship, and general recommendations for sleep and lifestyle management.
Participants will have access to the educational materials throughout the 8-week intervention period.
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The online patient education intervention will provide non-individualized educational materials covering tinnitus and insomnia, their potential interaction, and general strategies for sleep and lifestyle management.
The educational materials will be delivered through a smartphone-based online platform and will remain accessible throughout the 8-week intervention period.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Tinnitus Handicap Inventory (THI)
기간: 1 month, 2 months, 3 months, and 5 month from baseline
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The Tinnitus Handicap Inventory (THI) is a 25-item self-report questionnaire assessing the functional, emotional, and catastrophic impact of tinnitus.
Each item is scored as "yes" (4 points), "sometimes" (2 points), or "no" (0 points), with higher total scores indicating greater tinnitus-related impairment.
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1 month, 2 months, 3 months, and 5 month from baseline
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Insomnia Severity Index (ISI)
기간: 1 month, 2 months, 3 months, and 5 month from baseline
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The Insomnia Severity Index (ISI) is a 7-item self-report questionnaire assessing the severity and impact of insomnia during the preceding two weeks.
It evaluates sleep initiation and maintenance difficulties, early morning awakening, dissatisfaction with sleep, daytime impairment, noticeability of sleep problems, and distress associated with sleep difficulties.
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1 month, 2 months, 3 months, and 5 month from baseline
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Sleep Onset Latency (SOL)
기간: Baseline and during the 8-week intervention period
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Sleep onset latency (SOL) will be assessed using a daily sleep diary.
SOL is defined as the amount of time required to fall asleep after going to bed.
Weekly average SOL will be calculated for outcome analysis.
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Baseline and during the 8-week intervention period
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Wake Time After Sleep Onset (WASO)
기간: Baseline and during the 8-week intervention period
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Wake time after sleep onset (WASO) will be assessed using a daily sleep diary.
WASO is defined as the total amount of time spent awake after initially falling asleep and before final awakening.
Weekly average WASO will be calculated for outcome analysis.
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Baseline and during the 8-week intervention period
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Total Sleep Time (TST)
기간: Baseline and during the 8-week intervention period
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Total sleep time (TST) will be assessed using a daily sleep diary.
TST is defined as the total amount of time spent asleep during the sleep period.
Weekly average TST will be calculated for outcome analysis.
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Baseline and during the 8-week intervention period
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Sleep Efficiency (SE%)
기간: Baseline and during the 8-week intervention period
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Sleep efficiency (SE%) will be assessed using a daily sleep diary and calculated as the percentage of time spent asleep relative to time spent in bed.
Weekly average sleep efficiency will be calculated for outcome analysis.
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Baseline and during the 8-week intervention period
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Visual Analogue Scale (VAS) for Tinnitus Loudness
기간: 1 month, 2 months, 3 months, and 5 month from baseline
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Subjective tinnitus loudness will be assessed using a 10-cm visual analogue scale ranging from 0 ("no tinnitus") to 10 ("extremely loud tinnitus").
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1 month, 2 months, 3 months, and 5 month from baseline
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Hospital Anxiety and Depression Scale (HADS)
기간: 1 month, 2 months, 3 months, and 5 month from baseline
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The Hospital Anxiety and Depression Scale (HADS) is a 14-item self-report questionnaire comprising two subscales: HADS-Anxiety (HADS-A) and HADS-Depression (HADS-D).
Each subscale contains seven items scored from 0 to 3, with scores ranging from 0 to 21.
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1 month, 2 months, 3 months, and 5 month from baseline
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Dysfunctional Beliefs and Attitudes About Sleep Scale (DBAS)
기간: 1 month, 2 months, 3 months, and 5 month from baseline
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The Dysfunctional Beliefs and Attitudes About Sleep Scale (DBAS) assesses maladaptive beliefs and attitudes regarding sleep, including rigid beliefs about required sleep duration, misconceptions regarding insomnia, and excessive concern about sleep.
Higher scores indicate greater endorsement of dysfunctional sleep-related cognitions.
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1 month, 2 months, 3 months, and 5 month from baseline
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Huawei Li, Ph.D, Eye and ENT Hospital of Fudan University
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
2026년 8월 24일
기본 완료 (추정된)
2029년 12월 30일
연구 완료 (추정된)
2029년 12월 30일
연구 등록 날짜
최초 제출
2026년 8월 13일
QC 기준을 충족하는 최초 제출
2026년 8월 13일
처음 게시됨 (실제)
2026년 8월 18일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 8월 18일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 8월 13일
마지막으로 확인됨
2026년 8월 1일
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .