ISRCTN92454702进行中（未招募）Unknown
A Phase III, unblinded, multi-centre randomised controlled trial to evaluate whether 3 months of spatial-listening training delivered via the Both EARS training package (BEARS) in addition to Usual Care compared to Usual Care alone improves hearing abilities and quality of life and is cost-effective in older children and teenagers with bilateral cochlear implants
试验速览
- 阶段
- Unknown
- 状态
- 进行中（未招募）
- 入组人数
- 384
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Participant is a simultaneous or sequential bilateral cochlear implant user*, who either has:
- •1.1. Congenital severe/profound bilateral sensorineural hearing loss and have received at least one implant =36 months of age
- •1.2. Progressive or acquired severe/profound bilateral sensorineural hearing loss (no age at implant restrictions for these patients)
- •2. Participant has stable programmes (defined as no longer using progressive programmes to work through)
- •3. Participant has had at least two usual care checks/clinical appointments with stable aided levels (+/-10 dB across 500 Hz-4 kHz) and no progressive maps to still work through, if they have had re-implantation of internal implant devices.
- •4. Participant is aged 8-16 years, inclusive
- •*(a bilateral CI user is defined as a patient who uses both CI processors for a minimum of 6 hours per day over a month)
排除标准
- •1. Participant (or parent/legal representative) does not speak/understand English sufficiently to undertake assessments
- •2. Participant has an intellectual disability at a level that would prevent their ability to understand the trial the intervention or assessment questions
- •3. Participant has a comorbid condition impacting ability to participate in intervention and/or outcome assessment
- •4. Participant has an audiological profile impacting ability to participate in intervention and/or outcome assessments
- •5. Participant is actively participating in other trials that may affect hearing outcomes or impact their ability to participate in the intervention
- •6. Participant is currently or anticipated to receive treatment and/or intervention that may affect hearing outcomes or adapt implant settings/programming
- •7. Participant is refusing to consent to trial activities/protocol
- •8. Participant is awaiting reimplantation following device failure or infection
- •9. Participant has had any changes to the programmes of either CI within the last 4 weeks
- •10. Participant has had a change of CI processor model or upgrade within the last 4 weeks
- •11. Participant is a non-user of one or both implant processors (i.e., must use both processors for a minimum of 6 hours per day over a month)
- •12. Participant is a full-time boarder at a boarding school
- •13. Participant has unresolvable issues found in device checks that render one of the implants unusable
- •14. Participant is a female that is pregnant
- •15. Participant has a diagnosis of epilepsy or history of seizures of any kind
研究者
相似试验
进行中（未招募）
1 期
Recombinant LH prior to ovarian stimulation in poor ovarian responders (PRE-LH).ovarian stimulation in poor ovarian respondersMedDRA version: 20.0Level: LLTClassification code 10071130Term: Controlled ovarian stimulationSystem Organ Class: 100000004865EUCTR2017-004298-15-ESIVI Alicante88
已完成
不适用
A Phase III randomised, double-blind, multicentre study to evaluate the safety and efficacy of 1592U89 (abacavir) in human immunodeficiency virus 1-infected patients with aquired immune deficiency syndrome dementia complexHIV-1 infection with AIDS dementiaInfections and InfestationsHIV, AIDSISRCTN53707238GlaxoSmithKline (UK)90
招募中
1 期
Study which tests 2 medications (SB27, Keytruda) to compare how effective, safe and well tolerated in a large number of metastatic non-squamous non-small cell lung cancer patientsCTIS2023-507448-36-00Samsung Bioepis Co. Ltd.616
尚未招募
3 期
Study which tests 2 medications (SB27, Keytruda) to compare how effective, safe and well tolerated in a large number of metastatic non-squamous non-small cell lung cancer patients.CTRI/2024/02/062974Samsung Bioepis Co Ltd
进行中（未招募）
1 期
Safety and efficacy of ATIR101 as adjunctive treatment to blood stem cell transplantation from a haploidentical family donor compared to post-transplant cyclophosphamide in patients with blood cancerPatients with a hematologic malignancy (AML, ALL, or MDS) who are eligible for a haploidentical HSCTMedDRA version: 20.0Level: LLTClassification code 10059044Term: Allogeneic peripheral hematopoietic stem cell transplantSystem Organ Class: 100000022080MedDRA version: 20.0Level: LLTClassification code 10000845Term: Acute lymphoblastic leukemiaSystem Organ Class: 100000012958MedDRA version: 20.0Level: PTClassification code 10027703Term: Mismatched donor bone marrow transplantation therapySystem Organ Class: 10042613 - Surgical and medical proceduresMedDRA version: 20.0Level: PTClassification code 10000880Term: Acute myeloid leukaemiaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: PTClassification code 10028533Term: Myelodysplastic syndromeSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2016-004672-21-ESKiadis Pharma Netherlands B.V.43