Trial Review

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The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

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 endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12608000586314
Ethics application status
Approved
Date submitted
8/10/2008
Date registered
21/11/2008
Date last updated
23/10/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
Eye movement responses in dizzy patients and healthy controls.
Scientific title
Comparison of spontaneous and provoked eye movement responses between dizzy patients and healthy controls.
Secondary ID [1] 283437 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
dizziness 3809 0
Condition category
Condition code
Ear 3991 3991 0 0
Other ear disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Spontaneous and provoked eye movements during provocative head tilts or rotations are recorded in dizzy patients with surface electrodes, and mask-mounted videocamera, and head motion sensor during the test time of approximately one hour . Head tilts are up to 45 degrees on each side, and head rotations are up to 30 degrees on each side. These movements are well within the range used during natural locomotion. The test is performed once within one test session at 1 week, at 3 months and at 1 year after the treatment.
Intervention code [1] 3529 0
Diagnosis / Prognosis
Comparator / control treatment
Spontaneous and provoked eye movements during provocative head tilts or rotations are recorded with surface electrodes, and mask-mounted videocamera, and head motion sensor during one test session of approximately one hour in healthy controls. The results of this single test session in controls is used for comparison with those of dizzy patients measured at three different time points. Head tilts are up to 45 degrees on each side, and head rotations are up to 30 degrees on each side. These movements are well within the range used during natural locomotion.
Control group
Active

Outcomes
Primary outcome [1] 4895 0
Abnormal nystagmus quantified with commercial three- dimensional video-oculography in three components.
Timepoint [1] 4895 0
at 1 week, at 3 months and at 1 year.
Secondary outcome [1] 8266 0
Unilateral weakness in caloric test will be analyzed from standard bithermal air provoked caloric nystagmus on each side using commercial video-oculography. Unilateral weakness is calculated by the software from the slow phase velocities of nystagmus during each stimuli.
Timepoint [1] 8266 0
at 1 week, at 3 months and at 1 year.

Eligibility
Key inclusion criteria
peripheral dizziness
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
other neurotological diseases

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/08/2003
Actual
1/08/2003
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment outside Australia
Country [1] 1257 0
Finland
State/province [1] 1257 0

Funding & Sponsors
Funding source category [1] 3990 0
Hospital
Name [1] 3990 0
Helsinki University Central Hospital
Country [1] 3990 0
Finland
Primary sponsor type
Individual
Name
Dr. Timo Hirvonen
Address
Haartmanstreet 4 E, 00029 Helsinki
Country
Finland
Secondary sponsor category [1] 3580 0
Hospital
Name [1] 3580 0
Helsinki University Central Hospital
Address [1] 3580 0
Haartmanstreet 4 E, 00029 Helsinki
Country [1] 3580 0
Finland

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6065 0
Ethics Committee of ophtalmology, otorhinolaryngology and neurosurgery
Ethics committee address [1] 6065 0
Secretary Kirsi-Marja Ayravainen, Toolo Hospital, P.O.Box 266, 00029 Helsinki
Ethics committee country [1] 6065 0
Finland
Date submitted for ethics approval [1] 6065 0
Approval date [1] 6065 0
16/10/2001
Ethics approval number [1] 6065 0
138/2001

Summary
Brief summary
The objective is to improve vestibular diagnostics in dizzy patients. The vestibular organ in inner ear senses motion, and controls eye movements to keep images stable. Vestibular dysfunction can be best characterized by comparing eye movement responses during motion stimuli.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29022 0
Dr Timo Hirvonen
Address 29022 0
Haartmanstreet 4 E, 00029 Helsinki
Country 29022 0
Finland
Phone 29022 0
+35894711
Fax 29022 0
Email 29022 0
[email protected]
Contact person for public queries
Name 12179 0
Dr. Timo Hirvonen
Address 12179 0
Haartmanstreet 4 E, 00029 Helsinki
Country 12179 0
Finland
Phone 12179 0
+35894711
Fax 12179 0
Email 12179 0
[email protected]
Contact person for scientific queries
Name 3107 0
Dr. Timo Hirvonen
Address 3107 0
Haartmanstreet 4 E, 00029 Helsinki
Country 3107 0
Finland
Phone 3107 0
+35894711
Fax 3107 0
Email 3107 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.