Otolith Function in Patients With Primary Ciliary Dyskinesia
|ClinicalTrials.gov Identifier: NCT01246258|
Recruitment Status : Completed
First Posted : November 23, 2010
Results First Posted : April 6, 2016
Last Update Posted : April 6, 2016
|Condition or disease||Intervention/treatment|
|Primary Ciliary Dyskinesia||Other: Vestibular evoked myogenic potentials (VEMPs) Other: Utricular centrifugation test|
Primary ciliary dyskinesia (PCD) is a genetically inherited condition. It is due to structural abnormalities of cilia, which are microscopic hairs found in organs and cells throughout the body. Patients with this condition typically develop upper respiratory tract symptoms such as sinusitis and glue ear, lower respiratory tract problems such as recurrent chest infections, and fertility problems. There is currently no evidence that patients with PCD have a higher incidence of balance problems. However, recent animal studies have shown that cilia may also be important in the development of part of the inner ear balance (vestibular) system, specifically the part that detects linear movement known as the otolith system.
The investigators hope to determine whether patients with PCD have absent or reduced otolith function compared to the normal population. Balance problems are not currently screened for in PCD patients, and could be unrecognized and therefore untreated. It is also possible that PCD patients have compensated for absent otolith function and so are unaffected under normal circumstances; any additional insult to their balance system would cause more pronounced difficulties than expected and treatment might need to reflect this.
|Study Type :||Observational|
|Actual Enrollment :||5 participants|
|Official Title:||Otolith Function in Patients With Primary Ciliary Dyskinesia: a Pilot Study|
|Study Start Date :||September 2010|
|Actual Primary Completion Date :||December 2013|
|Actual Study Completion Date :||December 2013|
Standard tests of balance function
Other: Vestibular evoked myogenic potentials (VEMPs)
Standard test of balance functionOther: Utricular centrifugation test
Standard test of balance function
- Vestibular Evoked Myogenic Potentials (VEMPs) [ Time Frame: one day ]These are the balance tests that specifically assess the otolith organ.
- Utricular Centrifugation Test (UCF) [ Time Frame: one day ]balance assessment
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01246258
|Charing Cross Hospital|
|London, United Kingdom, W6 8RF|
|Principal Investigator:||Joanne Rimmer, MA FRCS||Imperial College Healthcare NHS Trust|
|Study Director:||Jonny Harcourt, MA FRCS||Imperial College Healthcare NHS Trust|