TinnitusPhase 3NCT06623123
Oto Smartphone App in Treating Tinnitus Amongst Adult Patients Compared with Standard Talking Therapies
A Phase 3 study testing Oto Smartphone Application (Oto Health Ltd) and Tinnitus Retraining Therapy (TRT) in people with Tinnitus, run by East and North Hertfordshire NHS Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tinnitus
- What is being tested?
- Oto Smartphone Application (Oto Health Ltd) and Tinnitus Retraining Therapy (TRT)
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 20 Jun 2024to 20 Jun 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
East and North Hertfordshire NHS Trust
Stevenage, Hertfordshire, SG14AB
Amir Habeeb, MBBS BSc MSc MRCS (ENT) AFHEA, +447850592603, amir.habeeb1@nhs.net
Ananth Vijendren, BM FRCS (ORL-HNS) PhD
About this study
Official title: Multimodality Smartphone App Delivered Therapy for Tinnitus - a Protocol for a Randomised Controlled 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.
Read the 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.
- Conditions
- Tinnitus
- Being tested
- Oto Smartphone Application (Oto Health Ltd), Tinnitus Retraining Therapy (TRT)
- Keywords
- tinnitus, therapeutics, telemedicine, outcomes, otology, otolaryngology
- Medical subject headings
- Tinnitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Oto Smartphone Application (Oto Health Ltd) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tinnitus Burden
Tinnitus burden via Tinnitus Functional Index questionnaires at 0 months (T0), 1 month (T1), 3 months (T2) and 6 months (T3).
Measured: 6 months total post intervention start date
Secondary outcomes (2)
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).
Measured: 6 months total post intervention start date
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).
Measured: 6 months total post intervention start date
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2024
- Study start20 Jun 2024
- Primary completion20 Jun 2025 (estimated)
- Study completion20 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for TinnitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- East and North Hertfordshire NHS Trust
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Amir Habeeb, East and North Hertfordshire NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06623123
- Sponsor's protocol ID
- RD2023-05 OTO
- Other IDs
- Corporate Funding
- Status last verified
- Oct 2024
- First submitted
- 30 Sep 2024
- Last updated
- 2 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
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.
PubMed 21532953Vahedi 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.
PubMed 22952508Carlbring 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.
PubMed 29215315Mehdi 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.
PubMed 33212928Lewis 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.
PubMed 32234748Shargorodsky 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.
PubMed 20670725
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multimodality Smartphone App Delivered Therapy for Tinnitus - a Protocol for a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT06623123
- Acronym / sponsor ID
- RD2023-05 OTO
- Conditions
- Tinnitus
- Keywords
- tinnitus, therapeutics, telemedicine, outcomes, otology, otolaryngology
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- East and North Hertfordshire NHS TrustOther government
- Study start
- 20 Jun 2024 (actual)
- Primary completion
- 20 Jun 2025 (estimated)
- Study completion
- 20 Jun 2025 (estimated)
- First posted
- 2 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tinnitus Retraining Therapy (TRT) Arm | Active comparator | Behavioral: Tinnitus Retraining Therapy (TRT)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. |
| Oto Smartphone Application | Experimental | Device: Oto Smartphone Application (Oto Health Ltd)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oto Smartphone Application (Oto Health Ltd)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 |
| Tinnitus Retraining Therapy (TRT)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. | Behavioural | Tinnitus Retraining Therapy (TRT) Arm |
Primary outcome
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).
2 secondary outcomes
Insomnia Severity
Time frame: 6 months total post intervention start date
Quality of Life
Time frame: 6 months total post intervention start date
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2024.
- Background: PubMed 21532953Morin 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.
- Background: PubMed 22952508Vahedi 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.
- Background: PubMed 29215315Carlbring 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.
- Background: PubMed 33212928Mehdi 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.
- Background: PubMed 32234748Lewis 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.
- Background: PubMed 20670725Shargorodsky 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.
- RandomiserLink provided by the sponsor.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Oto Smartphone Application (Oto Health Ltd) and Tinnitus Retraining Therapy (TRT) in people with Tinnitus, run by East and North Hertfordshire NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Amir Habeeb, MBBS BSc MSc MRCS (ENT) AFHEA (+447850592603, amir.habeeb1@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tinnitus Burden (time frame: 6 months total post intervention start date). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06623123, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2024; AzTrials last refreshed its copy on 8 Nov 2026.