Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001900202
Ethics application status
Approved
Date submitted
20/11/2018
Date registered
22/11/2018
Date last updated
1/11/2019
Date data sharing statement initially provided
22/11/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Testing a new obstructive sleep apnoea (OSA) catheter for assessing airway collapse
Scientific title
Clarifying the location and mechanism of upper airway collapse in obstructive sleep apnoea: Testing of a multimodal manometry catheter
Secondary ID [1] 296660 0
TGA CTN number CT-2018-CTN-02515-1
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obstructive sleep apneoa 310495 0
Condition category
Condition code
Respiratory 309203 309203 0 0
Sleep apnoea

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study will be a polysomnography (sleep study) conducted in a sleep laboratory. Participants will be prepared with standard monitoring devices used within typical sleep studies including the following:
* Electroencephalogram (EEG) – electrodes placed on the scalp for determination of sleep macro-architecture (total sleep time, time in Stage N1, N2, N3, and REM sleep, and sleep efficiency), and sleep micro-architecture (sleep onsets, arousals and awakenings).
* Eye movements (EOG) – electrodes placed 1cm diagonally below each eye for assessing sleep onset (slow rolling eye-movements) and rapid eye-movement (REM) sleep.
* Electrocardiogram (ECG) – electrodes placed on right clavicle, and left 8th intercostal space for determination of heart rate changes.
* Chin/jaw and leg electromyogram (EMG) – electrodes place on the mandible and on the shins of the legs for assessing sleep stages (particularly muscle hypotonia in REM) and periodic leg movements.
* Finger pulse oximetry (SpO2%) for assessing oxygen desaturation events and peripheral vasoconstriction responses (changes in plethysmography signal).
* Respiratory effort via respiratory inductance plethysmography (RIP) bands placed around the thorax and abdomen measure respiratory effort.
The study will aim to record data for at least 6 hours of sleep and each stage of sleep.

In addition to this monitoring equipment a multimodal catheter and calibrated airflow sensor will be used.
The specialised multimodal catheter will be used to measure upper airway pressure and temperature whilst recording video evidence of airway collapse. The device has been developed by Alex Wall under the guidance of Prof. John Arkwright at Flinders University. Pressure and temperature measurements will be taken using fibre optic technology whilst bio-impedance will simultaneously provide corroboration of pressure and contact force. The catheter features a series of 13 equally spaced fibre optic pressure sensors mounted inside the lumen and 13 bio-impedance electrode rings span the catheter. A Medigus micro camera (around the size of a grain of rice) is mounted prior to the 13 sensors at the proximal end of the catheters sensing region with a single fibre optic sensor preceding the camera as a reference in the nasal cavity. The camera body and wire has been integrated within the catheter lumen to minimise the external protrusion and creating a flexible sealed unit.
The catheter will be passed through a cable gland in the mask worn by the participant during a standard over-night sleep study. This allows for an airtight seal before being advanced through the most patent nostril following nasal decongestion and topical anaesthesia (Lidocaine Gel 2%). Once in place, the catheter will be taped at the nose and will only be repositioned when sites of obstruction are identified during the study.
Two investigators will monitor and observe the over-night study from an adjoining room, whilst measurements and video records are logged.
The catheter is a Class IIa medical device.
Intervention code [1] 312967 0
Diagnosis / Prognosis
Comparator / control treatment
No control group, only known OSA patients will be used in this study
Control group
Uncontrolled

Outcomes
Primary outcome [1] 308175 0
Catheter based fibre optic pressure data (mmHg) to determine the location of the site(s) of collapse and the degree of occlusion that occurs during natural sleep
Timepoint [1] 308175 0
Recorded throughout the overnight sleep study
Primary outcome [2] 308207 0
Catheter based fibre optic temperature data (degrees C) to compare with external flow sensing in an attempt to infer flow and therefore the severity of reduced air flow due to airway obstruction during natural sleep.
Timepoint [2] 308207 0
Recorded throughout the overnight sleep study
Primary outcome [3] 308208 0
Catheter based micro camera video data to determine the anatomical features associated with and mechanism of collapse during natural sleep.
Timepoint [3] 308208 0
Recorded throughout the overnight sleep study
Secondary outcome [1] 354175 0
Catheter based bio-impedance pressure data to confirm fibre optic data for the location of the site(s) of obstruction, but to also define contact force of collapse during natural sleep.
(primary outcome)
Timepoint [1] 354175 0
Recorded throughout the overnight sleep study

Eligibility
Key inclusion criteria
* Obstructive sleep apnoea patients
* Body mass index (BMI) less than 35 kg/m2
* Apnoea hypopnoea index (AHI) greater than or equal to 20 /hr
* No nasal congestion
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Current smokers
* History of cardiac, respiratory, craniofacial or metabolic disorders
* Abnormal lung function (FEV1 or FVC < 80% predicted)
* Other relevant co-morbidities or co-existing sleep disorders (e.g. periodic limb movement disorder)
* Medications that may affect respiration
* Moustaches or beards likely to cause air leaks with a nasal mask.
* Adhesive, latex or any other allergy relevant to the study procedures

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
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
2/12/2019
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
15
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA,WA

Funding & Sponsors
Funding source category [1] 301239 0
Government body
Name [1] 301239 0
The National Health and Medical Research Council
Country [1] 301239 0
Australia
Primary sponsor type
University
Name
Flinders University
Address
Sturt Road, Bedford Park, SA 5042
Country
Australia
Secondary sponsor category [1] 300878 0
None
Name [1] 300878 0
Address [1] 300878 0
Country [1] 300878 0
Other collaborator category [1] 280437 0
Commercial sector/Industry
Name [1] 280437 0
Trajan Scientific and Medical
Address [1] 280437 0
7 Argent Place, Ringwood, Victoria 3134
Country [1] 280437 0
Australia
Other collaborator category [2] 280438 0
Commercial sector/Industry
Name [2] 280438 0
Arkwright Technologies
Address [2] 280438 0
18 Devonshire Road, Hawthorndene SA 5051
Country [2] 280438 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301978 0
Southern Adelaide Clinical Human Research Ethics Committee
Ethics committee address [1] 301978 0
Ethics committee country [1] 301978 0
Australia
Date submitted for ethics approval [1] 301978 0
22/12/2017
Approval date [1] 301978 0
17/05/2018
Ethics approval number [1] 301978 0
HREC/17/SAC/419
Ethics committee name [2] 301983 0
University of Western Australia Human Research Ethics Committee
Ethics committee address [2] 301983 0
Ethics committee country [2] 301983 0
Australia
Date submitted for ethics approval [2] 301983 0
18/09/2018
Approval date [2] 301983 0
24/10/2018
Ethics approval number [2] 301983 0
RA/4/20/4845

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 88746 0
Prof John Arkwright
Address 88746 0
Flinders University, Building T1, 1284 South Road, Tonsley, South Australia 5042
Country 88746 0
Australia
Phone 88746 0
+61 8 8201 2755
Fax 88746 0
Email 88746 0
[email protected]
Contact person for public queries
Name 88747 0
John Arkwright
Address 88747 0
Flinders University, Building T1, 1284 South Road, Tonsley, South Australia 5042
Country 88747 0
Australia
Phone 88747 0
+61 8 8201 2755
Fax 88747 0
Email 88747 0
[email protected]
Contact person for scientific queries
Name 88748 0
John Arkwright
Address 88748 0
Flinders University, Building T1, 1284 South Road, Tonsley, South Australia 5042
Country 88748 0
Australia
Phone 88748 0
+61 8 8201 2755
Fax 88748 0
Email 88748 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Patient confidentiality


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.