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Completed

NCT Number: NCT05647746

Comparative Assessment of Compumedics Somfit Sleep Monitoring Device

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

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Key information

Conditions

Sleep-Disordered Breathing Apnea Dyssomnias Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

SleepMetrics Pty Ltd

Heidelberg, VUC, 3084, Australia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Device

Each intervention is a separate diagnostic device. They will all be operating at the same time

Primary outcomes

  1. The AHI difference between the test device (Somfit) and gold standard (PSG)

    Time frame: 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

  2. The AHI difference between the test device (Somfit) and predicate device (WatchPAT)

    Time frame: 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 outcomes

  1. Difference between hypnogram percent agreements between WatchPAT and PSG, and between Somfit and PSG

    Time frame: 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)

  2. Hypnogram percent agreement between Somfit and PSG

    Time frame: 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

Other outcomes

  1. Respiratory Event Index (REI) for Somfit

    Time frame: The measure will be calculated for every participant following a single night sleep recording

    Additional outcome for sleep quality

  2. Oxygen Desaturation Index (ODI) for Somfit

    Time frame: The measure will be calculated for every participant following a single night sleep recording

    Additional outcome for sleep quality

  3. Average pulse rate (PR) for Somfit

    Time frame: The measure will be calculated for every participant following a single night sleep recording

    Additional outcome for sleep quality

Sponsors and collaborators

Lead sponsor

Compumedics Limited

Industry

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Dec 12, 2022
Registry last updated
Feb 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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