Comparative Assessment of Compumedics Somfit Sleep Monitoring Device

Not Applicable

Completed

• Conditions: Sleep-Disordered Breathing

• Registration Number: NCT05647746
• Lead Sponsor: Compumedics Limited

Brief Summary

To study whether Somfit is substantially equivalent to the existing approved devices for full polysomnography and home sleep apnea testing

Detailed Description

Sleep is recognized as one of the three pillars of health (i.e. nutrition, exercise and sleep). Poor quality and fragmented sleep leads to an increase in the risk for development of chronic health conditions. Given the importance of good quality sleep and its critical role in overall well-being, there is a need for regular monitoring and assessment of sleep quality in individuals. However, current technologies will only allow for this to be performed in sleep clinics and with the help of full polysomnography (PSG) systems which require the patients to spend a night at the clinic with several wired electrodes connected to their scalp. This "gold standard" technology is expensive and therefore does not allow to meet public health demand for diagnosis of sleep disorders, especially obstructive sleep apnea (OSA) and also can be uncomfortable for the patients and distort their natural sleep architecture. To solve this problem, Compumedics has recently developed a miniaturized, portable, automated and affordable sleep monitoring system with code name of "Somfit" which is attached to patients' forehead and can be used in the comfort of patients' home. While Somfit has already gained TGA approval, the aim of this study is to compare Somfit with the "gold standard" PSG and another approved portable sleep testing device, Itamar WatchPAT One, in terms of accuracy of characterising sleep neurological architecture and diagnosing OSA, with the objective of applying for the international regulatory approvals.

Study Timeline

• Study First Submitted: 2022-12-01
• Study First Submitted QC: 2022-12-08
• Study Start: 2022-12-10
• Study First Posted: 2022-12-12
• Primary Completion: 2023-02-28
• Study Completion: 2023-05-31
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-05
• Last Update Posted: 2024-02-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 108

Inclusion Criteria

• Individuals aged 18 years or over
• Be able to give informed consent
• Referral for a diagnostic sleep study with indication of suspected sleep disordered breathing or history of diagnosed sleep disordered breathing

Exclusion Criteria

• Less than 18 years of age
• Unable or not willing to provide informed consent
• Need for nursing attendance during the time between 9 pm and 9 am
• Use of any OSA treatments during any part of the PSG study
• Previous reaction to skin preparation, tapes and electrode gels used at PSG

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
The AHI difference between the test device (Somfit) and gold standard (PSG)	Data required for the primary outcome measure are generated in the course of single night sleep recording for every participant. Statistical estimation will be performed after completion of all sleep recordings	AHI is the apnea hypopnea index, main measure of presence/severity of OSA (obstructive sleep apnea). it will test the null hypothesis that Somfit AHI is not equivalent to the AHI reported by PSG
The AHI difference between the test device (Somfit) and predicate device (WatchPAT)	Data required for this primary outcome measure are generated in the course of single night sleep recording for every participant. Statistical estimation will be performed after completion of all sleep recordings	AHI is the apnea hypopnea index, main measure of presence/severity of OSA (obstructive sleep apnea). it will test the null hypothesis that Somfit AHI is not equivalent to the AHI reported by PSG

Secondary Outcome Measures

Name	Time	Method
Hypnogram percent agreement between Somfit and PSG	Data required for this outcome measure are generated in the course of single night sleep recording for every participant. Statistical estimation will be performed after completion of all sleep recordings	It will test the null hypothesis that the accuracy of sleep staging performed by the test device (Somfit) is inferior to that demonstrated by the accredited sleep technologists
Difference between hypnogram percent agreements between WatchPAT and PSG, and between Somfit and PSG	Data required for this outcome measure are generated in the course of single night sleep recording for every participant. Statistical estimation will be performed after completion of all sleep recordings	It will test the null hypothesis that the accuracy of sleep staging performed by the test device (Somfit) is inferior to that of the predicate device (WatchPAT)

Trial Locations

Locations (1)

SleepMetrics Pty Ltd; 🇦🇺 Heidelberg, VUC, Australia