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.

Resmed0 个研究点目标入组 300 人开始时间: 2021年7月26日最近更新: 2021年8月10日

试验速览

暂无简介。

•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)

•. 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

发起方