Clinical trial NCT05647746: Comparative Assessment of Compumedics Somfit Sleep Monitoring Device
Official title: Performance Comparison of Compumedics Somfit Sleep Monitoring Device Against Home Sleep Apnoea Testing Device (Itamar WatchPAT) and Polysomnography
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep-Disordered Breathing
Lead sponsor: Compumedics Limited
Sponsor class: INDUSTRY
First posted: 2022-12-12
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: As the study investigate performances of the diagnostic equipment, the three diagnostic devices can be applied to the single group of patients at the same time
Primary purpose: DIAGNOSTIC

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: The AHI difference between the test device (Somfit) and gold standard (PSG)
timeFrame: 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
measure: The AHI difference between the test device (Somfit) and predicate device (WatchPAT)
timeFrame: 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 outcomes:
measure: Difference between hypnogram percent agreements between WatchPAT and PSG, and between Somfit and PSG
timeFrame: 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
measure: Hypnogram percent agreement between Somfit and PSG
timeFrame: 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 outcomes:
measure: Respiratory Event Index (REI) for Somfit
timeFrame: The measure will be calculated for every participant following a single night sleep recording
measure: Oxygen Desaturation Index (ODI) for Somfit
timeFrame: The measure will be calculated for every participant following a single night sleep recording
measure: Average pulse rate (PR) for Somfit
timeFrame: The measure will be calculated for every participant following a single night sleep recording
Locations:
city: Heidelberg
country: Australia
facility: SleepMetrics Pty Ltd
state: VUC
Study officials:
References: