Efficacy of Internet-based Cognitive Behavioral Therapy for Insomnia in Patients With Tinnitus and Insomnia
2026年8月13日 更新者：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.
調査の概要
状態
まだ募集していません
詳細な説明
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.
研究の種類
介入
入学 (推定)
168
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Xiaoling Huang, MS
- 電話番号：+86-15800955305
- メール：xiaolingh2023@163.com
研究場所
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Shanghai Municipality
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Shanghai、Shanghai Municipality、中国、200031
- Fudan University Eye Ear Nose and Throat Hospital, Otorhinolaryngology Department
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コンタクト：
- Xiaoling Huang, MS
- 電話番号：+86-15800955305
- メール：xiaolingh2023@163.com
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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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アクティブコンパレータ：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Tinnitus Handicap Inventory (THI)
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Insomnia Severity Index (ISI)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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%)
時間枠：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
時間枠：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)
時間枠：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)
時間枠：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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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- 主任研究者：Huawei Li, Ph.D、Eye and ENT Hospital of Fudan University
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年8月24日
一次修了 (推定)
2029年12月30日
研究の完了 (推定)
2029年12月30日
試験登録日
最初に提出
2026年8月13日
QC基準を満たした最初の提出物
2026年8月13日
最初の投稿 (実際)
2026年8月18日
学習記録の更新
投稿された最後の更新 (実際)
2026年8月18日
QC基準を満たした最後の更新が送信されました
2026年8月13日
最終確認日
2026年8月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。