Ta strona została przetłumaczona automatycznie i dokładność tłumaczenia nie jest gwarantowana. Proszę odnieść się do angielska wersja za tekst źródłowy.

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

13 sierpnia 2026 zaktualizowane przez: 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.

Przegląd badań

Status

Jeszcze nie rekrutacja

Warunki

Interwencja / Leczenie

Szczegółowy opis

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 studiów

Interwencyjne

Zapisy (Szacowany)

168

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Lokalizacje studiów

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

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Nie

Opis

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.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Pojedynczy

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: 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.
Inny: 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.
Aktywny komparator: 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.
Inny: 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 mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Tinnitus Handicap Inventory (THI)
Ramy czasowe: 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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Insomnia Severity Index (ISI)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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%)
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Eye & ENT Hospital of Fudan University

Śledczy

  • Główny śledczy: Huawei Li, Ph.D, Eye and ENT Hospital of Fudan University

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Szacowany)

24 sierpnia 2026

Zakończenie podstawowe (Szacowany)

30 grudnia 2029

Ukończenie studiów (Szacowany)

30 grudnia 2029

Daty rejestracji na studia

Pierwszy przesłany

13 sierpnia 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

13 sierpnia 2026

Pierwszy wysłany (Rzeczywisty)

18 sierpnia 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

18 sierpnia 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

13 sierpnia 2026

Ostatnia weryfikacja

1 sierpnia 2026

Więcej informacji

Terminy związane z tym badaniem

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • 2025263

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIEZDECYDOWANY

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

Subskrybuj