Trial Review

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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
Scientific title
Obstructive Sleep Apnea suspected patients' neurodynamic assessment compared to polysomnography in diagnostic accuracy
Secondary ID [1] 285772 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obstructive Sleep Apnea 293654 0
Condition category
Condition code
Physical Medicine / Rehabilitation 293950 293950 0 0
Physiotherapy
Respiratory 293951 293951 0 0
Sleep apnoea

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 290731 0
Diagnosis / Prognosis
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.
Control group
Active

Outcomes
Primary outcome [1] 293725 0
Neurodynamic tests accuracy
Timepoint [1] 293725 0
cross-sectional study

conducted at single timepoint only
Primary outcome [2] 293988 0
statistical significance and accuracy tests values (sensibility, specificity, likelyhood ratio + and -)
Timepoint [2] 293988 0
conducted at single timepoint only
Secondary outcome [1] 311667 0
none
Timepoint [1] 311667 0
none

Eligibility
Key inclusion criteria
Patients with suspected OSA that has performed a polysomnography doing a visit to recive the diagnosis from the pneumologist
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
neurological diseases, oncological diseases,
facial and neck pain, central sensitization

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)
all consecutive patients will be offered participation in the study
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
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
8/01/2015
Actual
9/01/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
29
Accrual to date
Final
Recruitment outside Australia
Country [1] 6503 0
Italy
State/province [1] 6503 0
Milano

Funding & Sponsors
Funding source category [1] 290336 0
Self funded/Unfunded
Name [1] 290336 0
none
Country [1] 290336 0
Primary sponsor type
Individual
Name
Giacomo Carta
Address
Istituti Clinici di Perfezionamento

Viale Andrea Doria 52
Milano
20122
Country
Italy
Secondary sponsor category [1] 289053 0
None
Name [1] 289053 0
Address [1] 289053 0
Country [1] 289053 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292042 0
Comitato Etico Istituti Clinici di Perfezionamento Milano
Ethics committee address [1] 292042 0
Ethics committee country [1] 292042 0
Italy
Date submitted for ethics approval [1] 292042 0
01/12/2014
Approval date [1] 292042 0
07/01/2015
Ethics approval number [1] 292042 0

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 52550 0
Dr Giacomo Carta
Address 52550 0
Istituti Clinici di Perfezionamento

Viale Andrea Doria 52, Milano 20122
Country 52550 0
Italy
Phone 52550 0
+39 3405950493
Fax 52550 0
Email 52550 0
[email protected]
Contact person for public queries
Name 52551 0
Giacomo Carta
Address 52551 0
Istituti Clinici di Perfezionamento

Viale Andrea Doria 52, Milano 20122
Country 52551 0
Italy
Phone 52551 0
+39 3405950493
Fax 52551 0
Email 52551 0
[email protected]
Contact person for scientific queries
Name 52552 0
Giacomo Carta
Address 52552 0
Isituti Clinici di Perfezionamento

Viale Andrea Doria 52, Milano 20122
Country 52552 0
Italy
Phone 52552 0
+39 3405950493
Fax 52552 0
Email 52552 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.