Last reviewed · How we verify
NCT03287700: FOUNDATION
Designing a Trial of Bilateral Cochlear Implantation in Adults
trial testing No intervention in Hearing Loss, Bilateral in 86 participants. Status unknown.
2 August 2019
Quick facts
| Lead sponsor | Nottingham University Hospitals NHS Trust |
|---|---|
| Status | Status unknown |
| Study type | OBSERVATIONAL |
| Enrollment | 86 |
| Start date | 14 June 2017 |
| Primary completion | 2 August 2019 |
| Estimated completion | 2 August 2019 |
| Sites | 1 location across United Kingdom |
Drugs / interventions tested
- No intervention
Conditions studied
- Hearing Loss, Bilateral — all drugs for Hearing Loss, Bilateral →
- Hearing Loss, Sensorineural — all drugs for Hearing Loss, Sensorineural →
Sponsor
Nottingham University Hospitals NHS Trust
Who can join
18 and older, any sex, with Hearing Loss, Bilateral or Hearing Loss, Sensorineural. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
In the UK, cochlear implantation is the standard treatment for adults with 'severe-to-profound' deafness. This level of deafness means that without a cochlear implant they have difficulty understanding what people are saying even when they wear hearing aids. The NHS provides a cochlear implant for one ear even though these adults are deaf in both ears. Two cochlear implants could help them understand speech in noisy environments, know where to look to see who is talking, and avoid hazards outdoors. The decision about who can receive cochlear implants and how many they can receive is based on guidance from the National Institute for Health and Care Excellence (NICE). NICE agreed that providing two cochlear implants can provide additional benefits over providing just one implant. However, they decided that there is not enough evidence to show that these additional benefits are worth the additional cost of providing the second implant. NICE recommended that a clinical trial should be conducted to gather this evidence. This study will consult with patients to explore whether the trial would be acceptable to future implant recipients. The study will also work with clinicians to design a trial comparing bilateral and unilateral implantation in adults. These clinicians will also be surveyed to assess the acceptability of the trial. A group of clinicians that span the range of professions involved in delivering the care pathway will be invited to attend a trial design workshop to establish a consensus on acceptable trial design elements from a clinical perspective. Representatives from cochlear implant manufacturers will be consulted to determine possible strategies for securing industry support for a future trial. Those who run cochlear implantation services will be engaged in a working group to gather information on the current care pathway to inform future assessments of whether bilateral implantation could be cost-effective.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT03287700
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
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Other recruiting trials for Hearing Loss, Bilateral
Currently open trials in the same condition.
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Other Nottingham University Hospitals NHS Trust trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03287700 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Nottingham University Hospitals NHS Trust
- Last refreshed: 22 May 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03287700.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing