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NCT Number: NCT06623123

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

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.

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Key information

Conditions

Tinnitus Ear Diseases Hearing Disorders Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

East and North Hertfordshire NHS Trust

Stevenage, Hertfordshire, SG14AB, United Kingdom

Location status: Recruiting

Location contact

Amir Habeeb, MBBS BSc MSc MRCS (ENT) AFHEA

CONTACT

[email protected]

+447850592603

Amir Habeeb, MBBS BSc MSc MRCS (ENT) AFHEA

CONTACT

Ananth Vijendren, BM FRCS (ORL-HNS) PhD

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult patients (male or female) aged over 18 years of age presenting to NHS ENT and hearing 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 smartphone device capable of running Oto.
  • Willing and able to provide written informed consent.
  • Those that would be offered tinnitus retraining therapy (TRT) as management for their primary tinnitus

Exclusion criteria

  • Patients with secondary tinnitus as confirmed by magnetic resonance imaging (MRI).
  • Patients undergoing any other tinnitus therapies concurrently (including hearing aids / implants). Previous tinnitus therapies including CBT in the past are accepted.
  • Patients who are not willing to use the app due to not having a suitable phone to download the application or due to own limitations in working Oto.

Treatment and study plan

Oto Smartphone Application (Oto Health Ltd)

Device

The smartphone application delivers personalized tinnitus therapy combining evidence-based CBT with mindfulness, patient education as well as physical therapy such as stretches and exercises. There are additional sounds available to listen to from the sound library. There will be a structured programme that the participants can work through however they are encouraged to personalise their own therapy.

Tinnitus Retraining Therapy (TRT)

Behavioral

Tinnitus-retraining therapy will be offered in the control arm which represents the standard evidence-based intervention on the NHS. (2) Participants enrolled to this arm will undertake tinnitus retraining therapy with a trained audiologist. The sessions will last 30 minutes with the option for further sessions should the patient which to have more support with their tinnitus to mimic the NHS programme as much as possible. These sessions will encompass a brief audiological history followed by therapy tailored to the patient's needs allowing for patient-centred optimisation of tinnitus burden and secondary comorbidities. This may include relaxation, CBT and advice surrounding sound as well as white noise masking therapy.

Primary outcomes

  1. Tinnitus Burden

    Time frame: 6 months total post intervention start date

    Tinnitus burden via Tinnitus Functional Index questionnaires at 0 months (T0), 1 month (T1), 3 months (T2) and 6 months (T3).

Secondary outcomes

  1. Insomnia Severity

    Time frame: 6 months total post intervention start date

    Insomnia index as calculated via Insomnia Severity Index questionnaire at 0 months (T0), 1 month (T1), 3 months (T2) and 6 months (T3).

  2. Quality of Life

    Time frame: 6 months total post intervention start date

    Quality of life as calculated via the WHO Quality of Life - BREF questionnaire at 0 months (T0), 1 month (T1), 3 months (T2) and 6 months (T3).

Study contacts

Contact information is provided by the study sponsor or research team.

Amir Habeeb, MBBS BSc MSc MRCS (ENT) AFHEA

CONTACT

[email protected]

+447850592603

Sponsors and collaborators

Lead sponsor

East and North Hertfordshire NHS Trust

Other Gov

Registry information

Official study title

Multimodality Smartphone App Delivered Therapy for Tinnitus - a Protocol for a Randomised Controlled Trial

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 2, 2024
Registry last updated
Oct 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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