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

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.

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12621000978864
Enrollment
300
Registered
2021-07-26
Start date
2021-11-01
Completion date
2022-11-01
Last updated
2021-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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 Inform

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.

Sponsors

Resmed
Lead SponsorCommercial sector/Industry

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026