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Trial registered on ANZCTR
Registration number
ACTRN12615000172505
Ethics application status
Approved
Date submitted
2/12/2014
Date registered
23/02/2015
Date last updated
23/02/2015
Type of registration
Retrospectively registered
Titles & IDs
Public title
Diagnostic accuracy of two neurodynamic tests in Obstructive Sleep Apnea patients: a cross-sectional study
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Scientific title
Obstructive Sleep Apnea suspected patients' neurodynamic assessment compared to polysomnography in diagnostic accuracy
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Secondary ID [1]
285772
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None
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Obstructive Sleep Apnea
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Condition category
Condition code
Physical Medicine / Rehabilitation
293950
293950
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0
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Physiotherapy
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Respiratory
293951
293951
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0
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Sleep apnoea
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
A cross-sectional double blind study will be done on patients with suspected OSA receiving diagnosis with cardio-respiratory poligraphy.
Study will be conducted in an outpatient service of the public health system;
informed consent will be signed before recruitment; hypoglossal and
glossopharingeal neurodynamic non invasive tests will be performed by a physiotherapist, blinded from
pneumologist diagnosis consecutively to the visit. The neurodynamic tests approximate duration will be of 1 minute each. Neurodynamic tests will be conducted on a single occasion only. Neurodynamic tests will be conducted within 10 minutes of pneumologist diagnosis.
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Intervention code [1]
290731
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Diagnosis / Prognosis
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Comparator / control treatment
Results of neurodynamic tests will be compared to the pneumologist diagnosis.
Pneumologist diagnosis will be performed after assessment of the polysomnography results.
Polysomnography needs a recording of the sleeping during an entire night through some wearable devices. Data recorded need to be downloaded from the devices and analized through a PC software (10 minutes). Pneumologist interpretation of the software results and the diagnosis formulation needs approximately 20 minutes.
The neurodynamic tests approximate duration will be of 1 minute each and will be conducted on a single occasion only.
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Control group
Active
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Outcomes
Primary outcome [1]
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Neurodynamic tests accuracy
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Assessment method [1]
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Timepoint [1]
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cross-sectional study
conducted at single timepoint only
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Primary outcome [2]
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statistical significance and accuracy tests values (sensibility, specificity, likelyhood ratio + and -)
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Assessment method [2]
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Timepoint [2]
293988
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conducted at single timepoint only
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Secondary outcome [1]
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none
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Assessment method [1]
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Timepoint [1]
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none
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Eligibility
Key inclusion criteria
Patients with suspected OSA that has performed a polysomnography doing a visit to recive the diagnosis from the pneumologist
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
neurological diseases, oncological diseases,
facial and neck pain, central sensitization
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Study design
Purpose of the study
Diagnosis
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
all consecutive patients will be offered participation in the study
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Safety/efficacy
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Statistical methods / analysis
Sample size was of 29 patients. It was calculated considering the margin of error of 5%, confidence level of 99%, population size of 30 and response distribution of 50% (positive or negative to the tests/ diagnosis).
Correlation between pneumologist diagnosis and physical therapist assessment will be assessed using Pearson’s Rho Test and statistical significance is set to P = 0.05.
Accuracy will be assessed calculating Sensibility, specificity, Likelyhood positive and negative values
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
8/01/2015
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Actual
9/01/2015
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
29
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Accrual to date
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Final
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Recruitment outside Australia
Country [1]
6503
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Italy
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State/province [1]
6503
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Milano
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Funding & Sponsors
Funding source category [1]
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Self funded/Unfunded
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Name [1]
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none
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Address [1]
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Country [1]
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Primary sponsor type
Individual
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Name
Giacomo Carta
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Address
Istituti Clinici di Perfezionamento
Viale Andrea Doria 52
Milano
20122
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Country
Italy
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
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Country [1]
289053
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Comitato Etico Istituti Clinici di Perfezionamento Milano
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Ethics committee address [1]
292042
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Ethics committee country [1]
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Italy
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Date submitted for ethics approval [1]
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01/12/2014
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Approval date [1]
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07/01/2015
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Ethics approval number [1]
292042
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Summary
Brief summary
The study aim is to investigate validity of craniofacial Neurodynamic tests on diagnosis of respiratory disturbance in OSA patients. Obstructive sleep apnea (OSA) is characterized by the collapse of the upper airway during sleep. The most effective treatment for OSA is continuous positive airway pressure therapy (CPAP), but it is poorly tolerated by some. Many studies revealed a connection between respiratory episodes and muscular dysfunction of the jaw and the neck muscles. However, no studies have evaluated the responsiveness to a noninvasive neurodynamic test in OSA patients, performed by passive gentle motion of craniocervical district with patient lying supine on the couch.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Giacomo Carta
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Address
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Istituti Clinici di Perfezionamento
Viale Andrea Doria 52, Milano 20122
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Country
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Italy
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Phone
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+39 3405950493
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Giacomo Carta
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Address
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Istituti Clinici di Perfezionamento
Viale Andrea Doria 52, Milano 20122
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Country
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Italy
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Phone
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+39 3405950493
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Giacomo Carta
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Address
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Isituti Clinici di Perfezionamento
Viale Andrea Doria 52, Milano 20122
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Country
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Italy
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Phone
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+39 3405950493
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Fax
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Email
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[email protected]
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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.
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