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

ConditionTinnitus
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorEast and North Hertfordshire NHS Trust

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

160 Participants
are divided into 2 treatment groups
Group A: Tinnitus Retraining Therapy (TRT) ArmActive comparator 1 intervention
Group B: Oto Smartphone ApplicationExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Tinnitus Burden

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

Time frame
6 months total post intervention start date

Secondary outcomes

1

Insomnia Severity

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

Time frame
6 months total post intervention start date
2

Quality of Life

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).

Time frame
6 months total post intervention start date

Other outcomes

Sponsors and contacts

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