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Trial registered on ANZCTR

Registration number
Ethics application status
Date submitted
Date registered
Date last updated
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
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
Respiratory 293951 293951 0 0
Sleep apnoea

Study type
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

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
Timepoint [1] 311667 0

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
Both males and females
Can healthy volunteers participate?
Key exclusion criteria
neurological diseases, oncological diseases,
facial and neck pain, central sensitization

Study design
Purpose of the study
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
Not Applicable
Type of endpoint(s)
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 status
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment outside Australia
Country [1] 6503 0
State/province [1] 6503 0

Funding & Sponsors
Funding source category [1] 290336 0
Self funded/Unfunded
Name [1] 290336 0
Address [1] 290336 0
Country [1] 290336 0
Primary sponsor type
Giacomo Carta
Istituti Clinici di Perfezionamento

Viale Andrea Doria 52

Secondary sponsor category [1] 289053 0
Name [1] 289053 0
Address [1] 289053 0
Country [1] 289053 0

Ethics approval
Ethics application status
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
Date submitted for ethics approval [1] 292042 0
Approval date [1] 292042 0
Ethics approval number [1] 292042 0

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

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

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

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

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

No information has been provided regarding IPD availability
Summary results
No Results