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NCT05154539: InHEAR
Innovation of Hearing Rehabilitation and Effects of Reform
NA trial testing Remote digital assessment in Hearing Loss in 751 participants. Completed in 1 June 2022.
1 June 2022
Quick facts
| Lead sponsor | Aalborg University Hospital |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | screening |
| Enrollment | 751 |
| Start date | 16 March 2021 |
| Primary completion | 1 June 2022 |
| Estimated completion | 1 June 2022 |
| Sites | 1 location across Denmark |
Drugs / interventions tested
- Remote digital assessment
- Conventional physical assessment
Conditions studied
- Hearing Loss — all drugs for Hearing Loss →
Sponsor
Aalborg University Hospital
Who can join
18 and older, any sex, with Hearing Loss. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The Danish health care system has been criticized for its structural inefficiency and latency to initiate proper hearing rehabilitation amongst hearing-impaired individuals. Waiting lists are extensive, and audiometries are repeated before hearing aid treatment is initiated. Demographic changes forecast increasing numbers of +65-year-olds and consequently increased demand for hearing rehabilitation. To remedy this situation, the Danish Ministry of Health has proposed a new national initiative to implement innovative digital approaches to improve hearing rehabilitation, including a new, digital remote assessment routine. The aim of this study is to investigate: Primarily: 1. Patient safety of remote vs. conventional assessment 2. Patient-reported satisfaction and treatment effect of remote vs. conventional assessment Secondarily: 3. Inter-subspecialty and inter-personal assessment differences between four ENT specialists using a remote assessment routine 4. Translation and validation of the Danish adapted version of the Consumer Ear Disease Risk Assessment (CEDRA) questionnaire. The main study is a randomized clinical trial with three arms and 1:1:1 assignment comprising 751 potential first-time adult hearing aid users. Since March 2021, 751 patients have been randomized and assigned to 20 different clinics. The remote assessment routine works well for both patients, assessors, and clinics. Inclusion is expected to end in December 2021 and overall study completion is anticipated in april 2022. Deficient diagnosis of complicating conditions in first time hearing aid users is the main concern in remote assessment. If the study shows the practice to be safe, it could form the foundation of a future nationwide implementation of remote care in Danish hearing rehabilitation.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT05154539
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Other Aalborg University Hospital 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 NCT05154539 (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 Aalborg University Hospital
- Last refreshed: 25 July 2022
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/NCT05154539.
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