Otolith Function in Patients With Primary Ciliary Dyskinesia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Imperial College Healthcare NHS Trust
ClinicalTrials.gov Identifier:
NCT01246258
First received: November 22, 2010
Last updated: March 8, 2016
Last verified: August 2014

November 22, 2010
March 8, 2016
September 2010
December 2013   (final data collection date for primary outcome measure)
Vestibular Evoked Myogenic Potentials (VEMPs) [ Time Frame: one day ] [ Designated as safety issue: No ]
These are the balance tests that specifically assess the otolith organ.
The results of the utricular centrifugation test, VEMPs & ocular counter-rolling test [ Time Frame: One session only ] [ Designated as safety issue: No ]
These are the balance tests that specifically assess the otolith organ. They will then be compared to normative data.
Complete list of historical versions of study NCT01246258 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Utricular Centrifugation Test (UCF) [ Time Frame: one day ] [ Designated as safety issue: No ]
balance assessment
Not Provided
 
Otolith Function in Patients With Primary Ciliary Dyskinesia
Otolith Function in Patients With Primary Ciliary Dyskinesia: a Pilot Study
The purpose of this study is to determine whether patients with primary ciliary dyskinesia (PCD) have reduced or absent otolith function.The otolith system is a specific part of the inner ear vestibular (balance) system that detects linear movement.

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.

Observational
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Not Provided
Not Provided
Non-Probability Sample
Ten patients from the PCD clinic at the Royal Brompton Hospital, London.
Primary Ciliary Dyskinesia
  • Other: Vestibular evoked myogenic potentials (VEMPs)
    Standard test of balance function
  • Other: Utricular centrifugation test
    Standard test of balance function
Test group
Standard tests of balance function
Interventions:
  • Other: Vestibular evoked myogenic potentials (VEMPs)
  • Other: Utricular centrifugation test
Rimmer J, Patel M, Agarwal K, Hogg C, Arshad Q, Harcourt J. Peripheral vestibular dysfunction in patients with primary ciliary dyskinesia: abnormal otoconial development? Otol Neurotol. 2015 Apr;36(4):662-9. doi: 10.1097/MAO.0000000000000592.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
5
December 2013
December 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • aged 16-30 years
  • Confirmed diagnosis of PCD under the care of the PCD team at the Royal Brompton Hospital

Exclusion Criteria:

  • Aged under 16 years
  • Unconfirmed or "suspected" PCD
  • Previous history of balance disorders or diagnoses
  • Previous history of sensorineural hearing loss
  • Previous middle or inner ear surgery (other than grommet insertion)
Both
16 Years to 30 Years   (Child, Adult)
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT01246258
JROHH0046
Yes
Not Provided
Not Provided
Imperial College Healthcare NHS Trust
Imperial College Healthcare NHS Trust
Not Provided
Principal Investigator: Joanne Rimmer, MA FRCS Imperial College Healthcare NHS Trust
Study Director: Jonny Harcourt, MA FRCS Imperial College Healthcare NHS Trust
Imperial College Healthcare NHS Trust
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP