Comparative Assessment of Compumedics Somfit Sleep Monitoring Device

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

108 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-10

Study Completion Date

2023-05-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Sleep-Disordered Breathing

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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 Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Outcome Assessors

The sleep technologists who assess the sleep study outcomes will be blinded to the device generating the diagnostic data

Interventions

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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

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No