Oto Smartphone App in Treating Tinnitus Amongst Adult Patients Compared with Standard Talking Therapies

Last updated: October 1, 2024
Sponsor: East and North Hertfordshire NHS Trust
Overall Status: Active - Recruiting

Phase

3

Condition

Tinnitus

Treatment

Oto Smartphone Application (Oto Health Ltd)

Tinnitus Retraining Therapy (TRT)

Clinical Study ID

NCT06623123
RD2023-05 OTO
Corporate Funding
  • Ages > 18
  • All Genders

Study Summary

A study that looks at treating tinnitus and its associated burden, insomnia and quality of life effects with a smartphone app when compared with the talking therapies already offered on the national health service. Three separate questionnaires will be used to collect this data from patients at regular time intervals.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Adult patients (male or female) aged over 18 years of age presenting to NHS ENT andhearing services with primary non-pulsatile tinnitus irrespective of hearing.

  • Patients must be suffering from tinnitus for a minimum of 3 months

  • Patients that have a willingness to use as well as have access to a smartphonedevice capable of running Oto.

  • Willing and able to provide written informed consent.

  • Those that would be offered tinnitus retraining therapy (TRT) as management fortheir primary tinnitus

Exclusion

Exclusion Criteria:

  • Patients with secondary tinnitus as confirmed by magnetic resonance imaging (MRI).

  • Patients undergoing any other tinnitus therapies concurrently (including hearingaids / implants). Previous tinnitus therapies including CBT in the past areaccepted.

  • Patients who are not willing to use the app due to not having a suitable phone todownload the application or due to own limitations in working Oto.

Study Design

Total Participants: 160
Treatment Group(s): 2
Primary Treatment: Oto Smartphone Application (Oto Health Ltd)
Phase: 3
Study Start date:
June 20, 2024
Estimated Completion Date:
June 20, 2025

Study Description

Single-site randomised controlled study looking at tinnitus burden, insomnia severity and quality of life in adults with chronic primary subjective tinnitus when using Oto smartphone app compared with National Institute for Health and Care Excellence (NICE) approved tinnitus retraining therapy. This will be assessed objectively through questionnaires at the baseline meeting, one month, three months and six months.

Connect with a study center

  • East and North Hertfordshire NHS Trust

    Stevenage, Hertfordshire SG14AB
    United Kingdom

    Active - Recruiting

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