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

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

Study Overview

• Status: Completed
• Conditions: Sleep-Disordered Breathing
• Intervention / Treatment: Device: Compumedics Somfit HSAT device, WatchPAT HSAT device, Compumedics Grael /E-series PSG system

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 Type: Interventional
• Enrollment (Actual): 108
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Eugene Zilberg, PhD; Phone Number: +61412225842; Email: ezilberg@compumedics.com.au
• Study Contact Backup: Name: Liz Kealy, MS; Phone Number: +61386690328; Email: lizkealy@sleepmetrics.com.au

Study Locations

• Australia
  • VUC
    • Heidelberg, VUC, Australia, 3084
      • SleepMetrics Pty Ltd

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Compumedics Limited

Study record dates

Study Major Dates

• Study Start (Actual): December 10, 2022
• Primary Completion (Actual): February 28, 2023
• Study Completion (Actual): May 31, 2023

Study Registration Dates

• First Submitted: December 1, 2022
• First Submitted That Met QC Criteria: December 8, 2022
• First Posted (Actual): December 12, 2022

Study Record Updates

• Last Update Posted (Actual): February 7, 2024
• Last Update Submitted That Met QC Criteria: February 5, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Apnea Syndromes
• Other Study ID Numbers: AJ259

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No