NCT06623123 Oto Smartphone App in Treating Tinnitus Amongst Adult Patients Compared with Standard Talking Therapies
| NCT ID | NCT06623123 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | East and North Hertfordshire NHS Trust |
| Condition | Tinnitus |
| Study Type | INTERVENTIONAL |
| Enrollment | 160 participants |
| Start Date | 2024-06-20 |
| Primary Completion | 2025-06-20 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 160 participants in total. It began in 2024-06-20 with a primary completion date of 2025-06-20.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06623123 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Tinnitus. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06623123 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 160 participants.
Is NCT06623123 currently recruiting?
Yes, NCT06623123 is actively recruiting participants. Contact the research team at amir.habeeb1@nhs.net for enrollment information.
Where is the NCT06623123 trial being conducted?
This trial is being conducted at Stevenage, United Kingdom.
Who is sponsoring the NCT06623123 clinical trial?
NCT06623123 is sponsored by East and North Hertfordshire NHS Trust. The trial plans to enroll 160 participants.