Tato stránka byla automaticky přeložena a přesnost překladu není zaručena. Podívejte se prosím na anglická verze pro zdrojový text.

Efficacy of Internet-based Cognitive Behavioral Therapy for Insomnia in Patients With Tinnitus and Insomnia

13. srpna 2026 aktualizováno: 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.

Přehled studie

Postavení

Zatím nenabíráme

Podmínky

Intervence / Léčba

Detailní popis

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.

Typ studie

Intervenční

Zápis (Odhadovaný)

168

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Studijní místa

  • Čína
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, Čína, 200031
        • Fudan University Eye Ear Nose and Throat Hospital, Otorhinolaryngology Department
        • Kontakt:

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dospělý
  • Starší dospělý

Přijímá zdravé dobrovolníky

Ne

Popis

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.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Singl

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: 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.
Jiný: Internet-based Cognitive Behavioral Therapy for Insomnia (CBT-I)
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.
Aktivní komparátor: 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.
Jiný: Online Patient Education
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.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Tinnitus Handicap Inventory (THI)
Časové okno: 1 month, 2 months, 3 months, and 5 month from baseline
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.
1 month, 2 months, 3 months, and 5 month from baseline

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Insomnia Severity Index (ISI)
Časové okno: 1 month, 2 months, 3 months, and 5 month from baseline
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.
1 month, 2 months, 3 months, and 5 month from baseline
Sleep Onset Latency (SOL)
Časové okno: Baseline and during the 8-week intervention period
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.
Baseline and during the 8-week intervention period
Wake Time After Sleep Onset (WASO)
Časové okno: Baseline and during the 8-week intervention period
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.
Baseline and during the 8-week intervention period
Total Sleep Time (TST)
Časové okno: Baseline and during the 8-week intervention period
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.
Baseline and during the 8-week intervention period
Sleep Efficiency (SE%)
Časové okno: Baseline and during the 8-week intervention period
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.
Baseline and during the 8-week intervention period
Visual Analogue Scale (VAS) for Tinnitus Loudness
Časové okno: 1 month, 2 months, 3 months, and 5 month from baseline
Subjective tinnitus loudness will be assessed using a 10-cm visual analogue scale ranging from 0 ("no tinnitus") to 10 ("extremely loud tinnitus").
1 month, 2 months, 3 months, and 5 month from baseline
Hospital Anxiety and Depression Scale (HADS)
Časové okno: 1 month, 2 months, 3 months, and 5 month from baseline
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.
1 month, 2 months, 3 months, and 5 month from baseline
Dysfunctional Beliefs and Attitudes About Sleep Scale (DBAS)
Časové okno: 1 month, 2 months, 3 months, and 5 month from baseline
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.
1 month, 2 months, 3 months, and 5 month from baseline

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Eye & ENT Hospital of Fudan University

Vyšetřovatelé

  • Vrchní vyšetřovatel: Huawei Li, Ph.D, Eye and ENT Hospital of Fudan University

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Odhadovaný)

24. srpna 2026

Primární dokončení (Odhadovaný)

30. prosince 2029

Dokončení studie (Odhadovaný)

30. prosince 2029

Termíny zápisu do studia

První předloženo

13. srpna 2026

První předloženo, které splnilo kritéria kontroly kvality

13. srpna 2026

První zveřejněno (Aktuální)

18. srpna 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

18. srpna 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

13. srpna 2026

Naposledy ověřeno

1. srpna 2026

Více informací

Termíny související s touto studií

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • 2025263

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NEROZHODNÝ

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

Předplatit