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

Comparative Assessment of Compumedics Somfit Sleep Monitoring Device

Sleep-Disordered Breathing

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.

Compumedics Somfit HSAT device, WatchPAT HSAT device, Compumedics Grael /E-series PSG system

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

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

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)

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

Comparative Assessment of Compumedics Somfit Sleep Monitoring Device

About this trial

Study ID

Status

Type

Phase

Placebo

Accepting

Not accepting

Trial Timing

What is this trial about?

What are the participation requirements?