Comparative Assessment of Compumedics Somfit Sleep Monitoring Device

Sleep-Disordered Breathing Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05647746
• Other study ID #: AJ259
• Status: Completed
• Phase: N/A
• Start date: December 10, 2022
• Est. completion date: May 31, 2023

Study information

• Verified date: February 2024
• Source: Compumedics Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: May 31, 2023
• Est. primary completion date: February 28, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Sleep Apnea Syndromes
• Sleep-Disordered Breathing

Intervention

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

Locations

Country	Name	City	State
Australia	SleepMetrics Pty Ltd	Heidelberg	VUC

Sponsors (1)

Lead Sponsor	Collaborator
Compumedics Limited

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Respiratory Event Index (REI) for Somfit	Additional outcome for sleep quality	The measure will be calculated for every participant following a single night sleep recording
Other	Oxygen Desaturation Index (ODI) for Somfit	Additional outcome for sleep quality	The measure will be calculated for every participant following a single night sleep recording
Other	Average pulse rate (PR) for Somfit	Additional outcome for sleep quality	The measure will be calculated for every participant following a single night sleep recording
Primary	The AHI difference between the test device (Somfit) and gold standard (PSG)	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	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
Primary	The AHI difference between the test device (Somfit) and predicate device (WatchPAT)	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	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
Secondary	Difference between hypnogram percent agreements between WatchPAT and PSG, and between Somfit and 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)	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
Secondary	Hypnogram percent agreement between Somfit and PSG	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	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