Clinical trial NCT06623123: Oto Smartphone App in Treating Tinnitus Amongst Adult Patients Compared with Standard Talking Therapies
Official title: Multimodality Smartphone App Delivered Therapy for Tinnitus - a Protocol for a Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Tinnitus
Keywords: tinnitus
therapeutics
telemedicine
outcomes
otology
otolaryngology
Lead sponsor: East and North Hertfordshire NHS Trust
Sponsor class: OTHER_GOV
First posted: 2024-10-02
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Tinnitus Burden
timeFrame: 6 months total post intervention start date
Secondary outcomes:
measure: Insomnia Severity
timeFrame: 6 months total post intervention start date
measure: Quality of Life
timeFrame: 6 months total post intervention start date
Other outcomes:
Locations:
city: Stevenage
country: United Kingdom
facility: East and North Hertfordshire NHS Trust
state: Hertfordshire
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.