HEADSPIN: Head position sensing for particle repositioning manoeuve
Research type
Research Study
Full title
HEAD position Sensing for the Particle repositioning manoeuvre technique IN benign paroxysmal positional vertigo a validation and feasibility study.
IRAS ID
349740
Contact name
Manhoar Bance
Contact email
Sponsor organisation
Cambridge University Hospitals NHS Foundation Trust and the University of Cambridge (joint sponsors)
Clinicaltrials.gov Identifier
00000, N/A
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
This is a study to investigate a device and app that has been developed to support healthcare workers perform a manoeuvre called a particle repositioning manoeuvre (PRM). This manoeuvre is used treat a common cause of vertigo called benign positional paroxysmal vertigo (BPPV). BPPV is caused by presence of debris in the balance organs called the semicircular canals.
This study is arranged in 3 parts. Initially we will validate a head sensing monitoring device and PRM application (app) to confirm that: the device and app accurately display the position of the balance organ throughout the PRM and that performing the PRM guided by our app does move the head through the correct set of positions to remove debris from the balance organ. The former will be achieved by reviewing head position as recorded by video capture (gold standard) technology vs our device. The second validation will be achieved using a specialised manikin head that contains a 3D printed inner ear. As the manikin is guided through the PRM we will observe the effects of the PRM on debris within the balance organ.
The second part is a feasibility and usability study. We will demonstrate the device to ENT nurses, ED doctors and General Practitioners. We will collect responses to a questionnaire regarding likelihood they would perform the PRM and their confidence in performing the PRM with or without access to a supporting device.
Finally, to assess feasibility of use in clinical practice we will recruit 20 patients with BPPV and randomise them into two groups: PRM by specialist practitioner or PRM by non-specialists but guided by the device. We will assess effectiveness of the PRM at 1month post PRM by telephone consultation using the dizziness handicap inventory and a BPPV outcome questionnaire. Non-specialist practitioners will complete an evaluation questionnaire.
REC name
Yorkshire & The Humber - Sheffield Research Ethics Committee
REC reference
25/YH/0066
Date of REC Opinion
28 May 2025
REC opinion
Further Information Favourable Opinion