CLEARA
Research type
Research Study
Full title
Prospective, multi-site study utilising a CE marked Cleara Talk nasal device in patients as prosthetic treatment option for nasal speech
IRAS ID
271743
Contact name
Ginette Phippen
Contact email
Sponsor organisation
Converse Healthcare Ltd
Duration of Study in the UK
0 years, 6 months, 1 days
Research summary
Being proposed is a prospective, multi-site study of a class I (Low risk) CE marked nasal obturator device called ClearaTalk manufactured by the Sponsor (Oxtex Ltd). The patient population for this study will be those presenting with nasal speech who are not surgical candidates.
Recruitment will take place across three sites within their respective specialist speech and language clinics and overarching speech and language network:
1) Salisbury District Hospital, Salisbury NHS Foundation Trust (Lead site)
2) John Radcliffe Hospital, Oxford University Hospitals NHS Foundation Trust
3) Queen Elizabeth Hospital Birmingham, University Hospitals Birmingham NHS Foundation TrustPatients will attend their routine clinical visit where they will undergo all of their standard of care assessments including a few minimally intensive research specific assessments.
Research specific assessments will include ClearaTalk device fitting and training. Patients will also be asked to complete a non-validated questionnaire specifically designed by the sponsor to gauge patient satisfaction with the device.
The primary objective of this study is to evaluate the change in speech for patients with nasal speech before use and when using the Cleara Talk device.
Secondary objectives:
-Safety and efficacy of the Cleara Talk device
-Patient reported outcomes assessed at baseline and 14 days post fitting.
-User acceptability of Cleara Talk device
-Device utilisation and compliance
-User experience and satisfaction over timeREC name
North East - Newcastle & North Tyneside 1 Research Ethics Committee
REC reference
19/NE/0308
Date of REC Opinion
8 Oct 2019
REC opinion
Favourable Opinion