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
Results First Received: October 5, 2015  
Study Type: Observational
Study Design: Observational Model: Case-Only;   Time Perspective: Cross-Sectional
Condition: Primary Ciliary Dyskinesia
Interventions: Other: Vestibular evoked myogenic potentials (VEMPs)
Other: Utricular centrifugation test

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Test Group Utricular centrifugation and VEMPs: Standard tests of balance function

Participant Flow:   Overall Study
    Test Group  
STARTED     5  
COMPLETED     5  
NOT COMPLETED     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Test Group Utricular centrifugation and VEMPs: Standard tests of balance function

Baseline Measures
    Test Group  
Number of Participants  
[units: participants]
  5  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     5  
>=65 years     0  
Gender  
[units: participants]
 
Female     0  
Male     5  
Region of Enrollment  
[units: participants]
 
United Kingdom     5  



  Outcome Measures
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1.  Primary:   Vestibular Evoked Myogenic Potentials (VEMPs)   [ Time Frame: one day ]

2.  Other Pre-specified:   Utricular Centrifugation Test (UCF)   [ Time Frame: one day ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Joanne Rimmer
Organization: Imperial Health
phone: 0061402931120
e-mail: rimmer.joanne@gmail.com


Publications of Results:

Responsible Party: Imperial College Healthcare NHS Trust
ClinicalTrials.gov Identifier: NCT01246258     History of Changes
Other Study ID Numbers: JROHH0046
Study First Received: November 22, 2010
Results First Received: October 5, 2015
Last Updated: March 8, 2016
Health Authority: United Kingdom: National Health Service