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Trial of Management of Chronic Tinnitus by Sound Therapy and Cognitive Behavioral Therapy

26. juni 2026 oppdatert av: Aya Ahmed Elsayed, Sohag University

Efficacy of Sound Therapy, Cognitive Behavioral Therapy and Their Combination in Management of Chronic Tinnitus

clinical trial: The main aim of this study is to compare the effectiveness of Cognitive Behavioral Therapy (CBT) and Sound Therapy, both individually and in combination, in the management of patients with chronic subjective tinnitus and to evaluate their impact on decreasing tinnitus severity, psychological wellbeing and quality of life.

Patients will be randomly divided into three groups:

  • Group A: patients will receive Sound Therapy.
  • Group B: patients will receive Cognitive Behavioral Therapy (CBT).
  • Group C: patients will receive Combined CBT + Sound Therapy.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

Because of the multifactorial nature of tinnitus, its effective management requires a multidisciplinary approach. While there is no single pullet mechanism of cure, current treatment strategies primary focus on reducing tinnitus related perception and minimizing its associated distress through auditory and psychological interventions.

Among these approaches, is the Sound Therapy which aims to decrease the contrast between tinnitus and related neural activity by introducing external sounds, which facilitates habituation and reducing tinnitus perception .

In contrast, Cognitive Behavioral Therapy (CBT) targets the patient's cognitive and emotional reaction to tinnitus by modifying maladaptive thoughts and behaviors, there by improving coping strategies and reducing tinnitus-related distress (Andersson, 2011). Recent evidence suggests that combining both modalities may provide superior outcomes compared to either approach alone, highlighting the potential value for integrated treatment strategies in tinnitus management (Hall et

Studietype

Intervensjonell

Registrering (Antatt)

60

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

  • Egypt
      • Sohag, Egypt
        • Sohag faculty of medicine
        • Ta kontakt med:

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Barn

Tar imot friske frivillige

Nei

Beskrivelse

Inclusion Criteria:

  • o Age: 18-65 years.

    • Hearing level: Patients with normal hearing or mild to moderate sensorineural hearing loss (to ensure homogeneity of the sample) (National Institute for Health and Care Excellence, 2020)
    • Complaint: patients with chronic subjective tinnitus (> 3 months).
    • Psychological state: Patients with stable general and psychological condition.

Exclusion Criteria:

  • o Age: <18, >65 years

    • Hearing level: Patients with severe hearing loss not suitable for sound therapy
    • Complaint: Objective tinnitus (vascular or muscular origin)
    • Psychological state: Patients with active psychiatric disorders requiring immediate intervention.
    • Active middle or external ear disease

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: Group A: patients will receive Sound Therapy
Atferdsmessig: Group A: sound therapy

Group A: Sound Therapy

  • Patients will receive individualized sound therapy using broadband noise or tinnitus maskers.
  • Daily use recommended for 2-4 hours/day.
  • Duration: 6 weeks.
  • Patient will be instructed on habituation-based listening techniques
Aktiv komparator: Group B: patients will receive Cognitive Behavioral Therapy (CBT).
Atferdsmessig: Group B: Cognitive Behavioral Therapy

Group B: Cognitive Behavioral Therapy (CBT)

• Structured CBT program consisting of 6 sessions over 6 weeks.

Each session categorization:

  • Psychoeducation about tinnitus
  • Cognitive restructuring of negative thoughts
  • Relaxation techniques (breathing exercises, muscle relaxation)
  • Attention diversion strategies
  • Sleep hygiene education
Aktiv komparator: Group C: patients will receive Combined CBT + Sound Therapy.
Atferdsmessig: Group A: sound therapy

Group A: Sound Therapy

  • Patients will receive individualized sound therapy using broadband noise or tinnitus maskers.
  • Daily use recommended for 2-4 hours/day.
  • Duration: 6 weeks.
  • Patient will be instructed on habituation-based listening techniques
Atferdsmessig: Group B: Cognitive Behavioral Therapy

Group B: Cognitive Behavioral Therapy (CBT)

• Structured CBT program consisting of 6 sessions over 6 weeks.

Each session categorization:

  • Psychoeducation about tinnitus
  • Cognitive restructuring of negative thoughts
  • Relaxation techniques (breathing exercises, muscle relaxation)
  • Attention diversion strategies
  • Sleep hygiene education
Atferdsmessig: Group C: Combined CBT + Sound Therapy

Group C: Combined Therapy

• Patients will receive both sound therapy and CBT simultaneously following the same protocol as above.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Primary outcome: Changes in tinnitus severity
Tidsramme: Baseline, immediately after completion of treatment , and 3 months after completion of treatment
Assessment of tinnitus severity using the Tinnitus Functional Index (TFI) . Higher scores indicate greater tinnitus severity. the TFI total score ranges from 0 to 100, with higher score s indicating greater tinnitus severity and functional impact
Baseline, immediately after completion of treatment , and 3 months after completion of treatment

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
chang in Visual Analog Scale (VAS) score
Tidsramme: Baseline, immediately after completion of treatment , and 3 months after completion of treatment
Assessment of tinnitus severity using the Visual Analog Scale (VAS) . the VAS score ranges from 0 to 10, with 0 indicate no tinnitus and 10 indicates the worst imaginable tinnitus. higher scores indicating greater tinnitus severity
Baseline, immediately after completion of treatment , and 3 months after completion of treatment
change in Tinnitus Handicap Inventory (THI) score
Tidsramme: Baseline, immediately after completion of treatment , and 3 months after completion of treatment
Assessment of tinnitus-related handicap and quality of life using Tinnitus Handicap Inventory (THI). the THI total score ranges from 0 to 100, with higher scores indicating greater tinnitus-related handicap and poorer quality of life.
Baseline, immediately after completion of treatment , and 3 months after completion of treatment

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Sohag University

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

10. juni 2026

Primær fullføring (Antatt)

10. september 2026

Studiet fullført (Antatt)

10. desember 2026

Datoer for studieregistrering

Først innsendt

11. juni 2026

Først innsendt som oppfylte QC-kriteriene

17. juni 2026

Først lagt ut (Faktiske)

24. juni 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

30. juni 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

26. juni 2026

Sist bekreftet

1. juni 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • Soh-Med-26-5-8MS

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

UBESLUTTE

IPD-planbeskrivelse

No decision has been made regarding the sharing of individual participant data at this time

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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