Creation of a Statistical Shape Model (SSM) of the head and airway to improve CPAP delivery in OSA using prospectively collected CT head scans

Not Applicable

• Conditions: Respiratory - Sleep apnoea; Obstructive Sleep Apnoea OSA

• Registration Number: ACTRN12621000978864
• Lead Sponsor: Resmed

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-07-26
• Last Update Posted: 10 August 2021

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 300

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)

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

• Study Type: Observational
• Study Design: Not specified