NCT05647746

Comparative Assessment of Compumedics Somfit Sleep Monitoring Device

Performance Comparison of Compumedics Somfit Sleep Monitoring Device Against Home Sleep Apnoea Testing Device (Itamar WatchPAT) and Polysomnography

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 108 (actual)
• Sponsor: Compumedics Limited · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Sleep-Disordered Breathing

Interventions

Type	Name	Description
DEVICE	Compumedics Somfit HSAT device, WatchPAT HSAT device, Compumedics Grael /E-series PSG system	Each intervention is a separate diagnostic device. They will all be operating at the same time

Timeline

• Start date: 2022-12-10
• Primary completion: 2023-02-28
• Completion: 2023-05-31
• First posted: 2022-12-12
• Last updated: 2024-02-07

Locations

1 site across 1 country: Australia