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Otolith Function in Patients With Primary Ciliary Dyskinesia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01246258
Recruitment Status : Completed
First Posted : November 23, 2010
Results First Posted : April 6, 2016
Last Update Posted : April 6, 2016
Information provided by (Responsible Party):
Imperial College Healthcare NHS Trust

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

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
Test Group Utricular centrifugation and VEMPs: Standard tests of balance function

Participant Flow:   Overall Study
    Test Group

  Baseline Characteristics

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
Test Group Utricular centrifugation and VEMPs: Standard tests of balance function

Baseline Measures
   Test Group 
Overall Participants Analyzed 
[Units: Participants]
[Units: Participants]
<=18 years   0 
Between 18 and 65 years   5 
>=65 years   0 
[Units: Participants]
Female   0 
Male   5 
Region of Enrollment 
[Units: Participants]
United Kingdom   5 

  Outcome Measures

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

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

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
First Submitted: November 22, 2010
First Posted: November 23, 2010
Results First Submitted: October 5, 2015
Results First Posted: April 6, 2016
Last Update Posted: April 6, 2016