Otolith Function in Patients With Primary Ciliary Dyskinesia
1 other identifier
observational
5
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Sep 2010
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2010
CompletedFirst Submitted
Initial submission to the registry
November 22, 2010
CompletedFirst Posted
Study publicly available on registry
November 23, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedResults Posted
Study results publicly available
April 6, 2016
CompletedApril 6, 2016
August 1, 2014
3.3 years
November 22, 2010
October 5, 2015
March 8, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Vestibular Evoked Myogenic Potentials (VEMPs)
These are the balance tests that specifically assess the otolith organ.
one day
Other Outcomes (1)
Utricular Centrifugation Test (UCF)
one day
Study Arms (1)
Test group
Standard tests of balance function
Interventions
Eligibility Criteria
Ten patients from the PCD clinic at the Royal Brompton Hospital, London.
You may qualify if:
- aged 16-30 years
- Confirmed diagnosis of PCD under the care of the PCD team at the Royal Brompton Hospital
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Charing Cross Hospital
London, W6 8RF, United Kingdom
Related Publications (1)
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.
PMID: 25226371RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Joanne Rimmer
- Organization
- Imperial Health
Study Officials
- PRINCIPAL INVESTIGATOR
Joanne Rimmer, MA FRCS
Imperial College Healthcare NHS Trust
- STUDY DIRECTOR
Jonny Harcourt, MA FRCS
Imperial College Healthcare NHS Trust
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 22, 2010
First Posted
November 23, 2010
Study Start
September 1, 2010
Primary Completion
December 1, 2013
Study Completion
December 1, 2013
Last Updated
April 6, 2016
Results First Posted
April 6, 2016
Record last verified: 2014-08