Otolith Function in Patients With Primary Ciliary Dyskinesia

Primary Ciliary Dyskinesia Clinical Trial

Official title:

Otolith Function in Patients With Primary Ciliary Dyskinesia: a Pilot Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01246258
• Other study ID #: JROHH0046
• Status: Recruiting
• Phase: N/A
• First received: November 22, 2010
• Last updated: August 14, 2013
• Start date: September 2010

Study information

• Verified date: August 2013
• Source: Imperial College Healthcare NHS Trust
• Contact: Joanne Rimmer, MA FRCS
• Phone: 07974159348
• Email: jrimmer[@]doctors.org.uk
• Is FDA regulated: No
• Health authority: United Kingdom: National Health Service
• Study type: Observational

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 30 Years

Eligibility

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)

Study Design

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Ciliary Motility Disorders
• Dyskinesias
• Kartagener Syndrome
• Primary Ciliary Dyskinesia

Intervention

Other:
• Utricular centrifugation test, vestibular evoked myogenic potentials & ocular counter-rolling test
Standard tests of balance function

Locations

Country	Name	City	State
United Kingdom	Charing Cross Hospital	London

Sponsors (1)

Lead Sponsor	Collaborator
Imperial College Healthcare NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The results of the utricular centrifugation test, VEMPs & ocular counter-rolling test	These are the balance tests that specifically assess the otolith organ. They will then be compared to normative data.	One session only	No