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

NCT06623123 | Recruiting Phase 3

• 2 other identifiers: RD2023-05 OTOCorporate Funding
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Tinnitus

Keywords

tinnitus; therapeutics; telemedicine; outcomes; otology; otolaryngology

Outcome Measures

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).

  6 months total post intervention start date

Secondary Outcomes (2)

• Insomnia Severity

  6 months total post intervention start date

• Quality of Life

  6 months total post intervention start date

Study Arms (2)

Tinnitus Retraining Therapy (TRT) Arm

ACTIVE COMPARATOR

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.

Behavioral: Tinnitus Retraining Therapy (TRT)

Oto Smartphone Application

EXPERIMENTAL

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.

Device: Oto Smartphone Application (Oto Health Ltd)

Interventions

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.

Oto Smartphone Application

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.

Tinnitus Retraining Therapy (TRT) Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• East and North Hertfordshire NHS Trust: lead

Study Sites (1)

East and North Hertfordshire NHS Trust

Stevenage, Hertfordshire, SG14AB, United Kingdom

RECRUITING

Related Publications (6)

• Morin CM, Belleville G, Belanger L, Ivers H. The Insomnia Severity Index: psychometric indicators to detect insomnia cases and evaluate treatment response. Sleep. 2011 May 1;34(5):601-8. doi: 10.1093/sleep/34.5.601.

  PMID: 21532953 BACKGROUND

• Vahedi S. World Health Organization Quality-of-Life Scale (WHOQOL-BREF): Analyses of Their Item Response Theory Properties Based on the Graded Responses Model. Iran J Psychiatry. 2010 Fall;5(4):140-53.

  PMID: 22952508 BACKGROUND

• Carlbring P, Andersson G, Cuijpers P, Riper H, Hedman-Lagerlof E. Internet-based vs. face-to-face cognitive behavior therapy for psychiatric and somatic disorders: an updated systematic review and meta-analysis. Cogn Behav Ther. 2018 Jan;47(1):1-18. doi: 10.1080/16506073.2017.1401115. Epub 2017 Dec 7.

  PMID: 29215315 BACKGROUND

• Mehdi M, Dode A, Pryss R, Schlee W, Reichert M, Hauck FJ. Contemporary Review of Smartphone Apps for Tinnitus Management and Treatment. Brain Sci. 2020 Nov 17;10(11):867. doi: 10.3390/brainsci10110867.

  PMID: 33212928 BACKGROUND

• Lewis S, Chowdhury E, Stockdale D, Kennedy V; Guideline Committee. Assessment and management of tinnitus: summary of NICE guidance. BMJ. 2020 Mar 31;368:m976. doi: 10.1136/bmj.m976. No abstract available.

  PMID: 32234748 BACKGROUND

• Shargorodsky J, Curhan GC, Farwell WR. Prevalence and characteristics of tinnitus among US adults. Am J Med. 2010 Aug;123(8):711-8. doi: 10.1016/j.amjmed.2010.02.015.

  PMID: 20670725 BACKGROUND

Related Links

• Randomiser

MeSH Terms

Conditions

Tinnitus

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Amir Habeeb, MBBS BSc MSc MRCS (ENT) AFHEA

CONTACT

+447850592603; amir.habeeb1@nhs.net

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: researchers to data generated
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 30, 2024
• First Posted: October 2, 2024
• Study Start: June 20, 2024
• Primary Completion: June 20, 2025
• Study Completion: June 20, 2025
• Last Updated: October 2, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

GB (1)