|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ANZCTR |
|
Last refreshed on:
|
13 January 2020 |
|
Main ID: |
ACTRN12615000172505 |
|
Date of registration:
|
23/02/2015 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
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 |
|
Date of first enrolment:
|
09/01/2015 |
|
Target sample size:
|
29 |
|
Recruitment status: |
Recruiting |
|
URL:
|
https://anzctr.org.au/ACTRN12615000172505.aspx |
|
Study type:
|
Interventional |
|
Study design:
|
Purpose: Diagnosis; Allocation: Non-randomised trial; Masking: Open (masking not used);Assignment: Single group;Type of endpoint: Safety/efficacy;
|
|
Phase:
|
Not Applicable
|
|
|
Countries of recruitment
|
|
Italy
| | | | | | | |
|
Contacts
|
|
Name:
|
Dr Giacomo Carta
|
|
Address:
|
Isituti Clinici di Perfezionamento
Viale Andrea Doria 52, Milano 20122
Italy |
|
Telephone:
|
+39 3405950493 |
|
Email:
|
giacomo.carta@gmail.com |
|
Affiliation:
|
|
|
|
Name:
|
Dr Giacomo Carta
|
|
Address:
|
Istituti Clinici di Perfezionamento
Viale Andrea Doria 52, Milano 20122
Italy |
|
Telephone:
|
+39 3405950493 |
|
Email:
|
giacomo.carta@gmail.com |
|
Affiliation:
|
|
| |
|
Key inclusion & exclusion criteria
|
Inclusion criteria: Patients with suspected OSA that has performed a polysomnography doing a visit to recive the diagnosis from the pneumologist
Exclusion criteria: neurological diseases, oncological diseases,
facial and neck pain, central sensitization
Age minimum:
18 Years
Age maximum:
No limit
Gender:
Both males and females
|
|
Health Condition(s) or Problem(s) studied
|
Obstructive Sleep Apnea ;
Obstructive Sleep Apnea
|
|
Respiratory - Sleep apnoea
|
|
Physical Medicine / Rehabilitation - Physiotherapy
|
|
Intervention(s)
|
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.
|
|
Primary Outcome(s)
|
Neurodynamic tests accuracy[cross-sectional study
conducted at single timepoint only]
|
|
statistical significance and accuracy tests values (sensibility, specificity, likelyhood ratio + and -)[conducted at single timepoint only]
|
|
Secondary Outcome(s)
|
|
none[none]
|
|
Source(s) of Monetary Support
|
|
none
|
|
Ethics review
|
Status: Approved
Approval date:
Contact:
Comitato Etico Istituti Clinici di Perfezionamento Milano
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|