Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000978864p
Ethics application status
Submitted, not yet approved
Date submitted
4/03/2021
Date registered
26/07/2021
Date last updated
26/07/2021
Date data sharing statement initially provided
26/07/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Creation of a Statistical Shape Model (SSM) of the head and airway to improve CPAP delivery in OSA using prospectively collected CT head scans
Scientific title
The effect of Creation of a Statistical Shape Model (SSM) of the head and airway on CPAP delivery in OSA using prospectively collected CT head scans.
Secondary ID [1] 302732 0
nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obstructive Sleep Apnoea OSA 320984 0
Condition category
Condition code
Respiratory 318791 318791 0 0
Sleep apnoea

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The study will consist of 4 stages:
* Recruitment
* Screening/Enrolment stage
* CT Scan/Imaging
* Follow up Stage

Recruitment
Up to 300 Adult OSA patients (AHI =15 on a sleep study within the last 6 years) and 20 normal controls (AHI less than 5 or, if no sleep study is available, an Epworth Sleepiness Score less than 10) will be recruited from the large network of Sleep Physicians and Otolaryngologists within the Western Sydney Local Health District.

Screening/Enrolnment Stage
Subject Informed Consent
Prior to enrolment in this study, all subjects must review and complete an EC-approved PICF. All potential subjects must complete the consent process prior to undergoing procedures performed specifically for this study that are outside the standard of care for the institution. Failure to obtain a signed PICF renders the subject ineligible for the study. Site will comply with ICH guidelines for obtaining informed consent.
Demographics
Demographic information (age, gender, height, weight, ethnicity) will be obtained during Screening as specified in the Schedule of Assessments for Subjects enrolled
Medical and Surgical history
A general medical history will be collected. In addition, the medical history will document conditions focusing specifically on the following: Ear, Nose, and Throat, CPAP History, Sleep Study results, Epworth Sleepiness score, contraindications to Otrivin (Xylometazoline) nasal decongestant. If Otrivin is contraindicated, the subject will fail screening.
CT Scan
A single CT scan of the head and neck will be performed at high resolution (slice thickness 0.6mm) with low dose radiation at a single site (Castlereagh Imaging, Westmead) using a calibrated scanning device (Siemens Somatom Definition Flash) which has been certified by Gammasonics as compliant with the Australian National Dose Level. A nasal decongestant spray (Otrivin/ Xylometazoline Hydrochloride 1 mg/mL 1 spray bilaterally in each nostril) will be administered 15 mins prior to scanning. A nasal decongestant spray (Otrivin/ Xylometazoline Hydrochloride 1 mg/mL 1 spray bilaterally in each nostril) will be administered 15 mins prior to scanning. The CT scan will take a few minutes (less than 5) to perform.
Follow Up
Follow up will occur around 1-2 weeks after the scan and will include a discussion of CT scan report with a member of the study team. If any incidental abnormality is detected, a study team doctor will perform the discussion and help arrange any required follow-up. No interventions will be performed.
Intervention code [1] 319895 0
Diagnosis / Prognosis
Comparator / control treatment
20 normal controls (AHI <5 or, if no sleep study is available, an Epworth Sleepiness Score <10) will be recruited from the large network of Sleep Physicians and Otolaryngologists within the Western Sydney Local Health District.

CT Scan
A single CT scan of the head and neck will be performed at high resolution (slice thickness 0.6mm) with low dose radiation at a single site (Castlereagh Imaging, Westmead) using a calibrated scanning device (Siemens Somatom Definition Flash) which has been certified by Gammasonics as compliant with the Australian National Dose Level. A nasal decongestant spray (Otrivin/ Xylometazoline Hydrochloride 1 mg/mL 1 spray bilaterally in each nostril) will be administered 15 mins prior to scanning. The CT scan will take a few minutes (<5) to perform.
Follow Up
Follow up will occur around 1-2 weeks after the scan and will include a discussion of CT scan report with a member of the study team. If any incidental abnormality is detected, a study team doctor will perform the discussion and help arrange any required follow-up. No interventions will be performed.
Control group
Active

Outcomes
Primary outcome [1] 326735 0

Primary outcome is develop a statistical shape model (SSM) of the head and airway using CT scans.
Timepoint [1] 326735 0
12 months post study commencement.
Secondary outcome [1] 393683 0
nil
Timepoint [1] 393683 0
nil

Eligibility
Key inclusion criteria
OSA cohort:
a. Age equal or greater than 18
b. Has been informed on the nature of study and is willing to give informed consent approved by the EC
c. Can read and comprehend English
d. Has clinically significant OSA diagnosis (AHI greater than 15)
e. Located in greater Sydney area

Healthy control cohort:
Same criteria as above except;
f. Not suffering from OSA (AHI less than 5)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
. A subject who meets any of the following criteria will be excluded from this study:
a. Participant with claustrophobia
b. Participant with extensive metallic and/or dental fillings
c. Participants with facial, cranial or other surgical implants in the head and neck
d. Participants with known allergy or sensitivity to common nasal dilator sprays
e. Patients who are pregnant

Control Group
Same as above except for OSA
f. Currently participating in an investigational drug or device study
g. Determined by the investigator as not suitable to be enrolled for reasons not already specified
if the health of the subject or the validity of the study outcomes could be compromised

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/11/2021
Actual
Date of last participant enrolment
Anticipated
1/11/2022
Actual
Date of last data collection
Anticipated
1/12/2022
Actual
Sample size
Target
300
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 33363 0
2153 - Bella Vista

Funding & Sponsors
Funding source category [1] 307157 0
Commercial sector/Industry
Name [1] 307157 0
Resmed
Country [1] 307157 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Resmed
Address
1 Elizabeth MacArthur Dr, Bella Vista NSW 2153
Country
Australia
Secondary sponsor category [1] 307747 0
None
Name [1] 307747 0
Address [1] 307747 0
Country [1] 307747 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 307273 0
Bellberry Limited
Ethics committee address [1] 307273 0
123 Glen Osmond Rd, Eastwood SA 5063
Ethics committee country [1] 307273 0
Australia
Date submitted for ethics approval [1] 307273 0
05/04/2021
Approval date [1] 307273 0
Ethics approval number [1] 307273 0

Summary
Brief summary
Otopure Pty Ltd in collaboration with ResMed is undertaking this study to generate a uniquely valuable data set that includes a statistically significant number of volunteers providing informed consent for prospective CT scanning that will allow for the generation of a Statistical Shape Model (SSM) of the head that incorporates the face and the upper aerodigestive tract. These SSM models will be able to generate usable, realistic geometry in any of these forms in a matter of minutes. The primary objective of this study is to generate a statistical shape model (SSM) of the head and airway in order to improve treatment for patients with OSA.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 106642 0
A/Prof Narinder Singh
Address 106642 0
Suite G6, Norwest Private Hospital, 11 Norbrik Drive, Bella Vista NSW 2153
Country 106642 0
Australia
Phone 106642 0
+61 02 9680 8800
Fax 106642 0
Email 106642 0
narinder@ents.com.au
Contact person for public queries
Name 106643 0
Mr Marin Duvnjak
Address 106643 0
Suite G6, Norwest Private Hospital, 11 Norbrik Drive, Bella Vista NSW 2153
Country 106643 0
Australia
Phone 106643 0
+61 02 9680 8800
Fax 106643 0
Email 106643 0
marin@ents.com.au
Contact person for scientific queries
Name 106644 0
A/Prof Narinder Singh
Address 106644 0
Suite G6, Norwest Private Hospital, 11 Norbrik Drive, Bella Vista NSW 2153
Country 106644 0
Australia
Phone 106644 0
+61 02 9680 8800
Fax 106644 0
Email 106644 0
narinder@ents.com.au

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


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.