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Evaluation of Compumedics "Somfit" Device

NCT ID: NCT04326127

Last Updated: 2020-03-31

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

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-11-06

Study Completion Date

2019-11-19

Brief Summary

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To study whether Somfit is substantially equivalent to an existing approved device (i.e. Compumedic's Grael System) to assist in elucidating sleep disorders.

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 will cause discomfort for the patients in a long run. To solve this problem, Compumedics has recently developed a miniaturized, portable and affordable sleep monitoring system with code name of "Somfit" which can be used in the comfort of patients' home. The aim of this study is to validate Somfit for home based sleep studies.

Conditions

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Sleep Apnea

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Control

Healthy volunteers

Intervention is the validation of a sleep monitoring device (i.e. Somfit) against the gold-standard polysomnograph with electroencephalograph (i.e. the Greal system)

Intervention Type DEVICE

Data were recorded overnight by both devices simultaneously

Case

Volunteers with diagnosed sleep apnea

Intervention is the validation of a sleep monitoring device (i.e. Somfit) against the gold-standard polysomnograph with electroencephalograph (i.e. the Greal system)

Intervention Type DEVICE

Data were recorded overnight by both devices simultaneously

Interventions

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Intervention is the validation of a sleep monitoring device (i.e. Somfit) against the gold-standard polysomnograph with electroencephalograph (i.e. the Greal system)

Data were recorded overnight by both devices simultaneously

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Individuals age between 18 to 75
* Be able to give informed consent
* Individuals with diagnosed Obstructive Sleep Apnoea (OSA)

Exclusion Criteria

* Less than 18 years of age
* Greater than 75 years of age
* Unable or not willing to provide informed consent
* Need for nursing care
* Currently working nightshift
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Compumedics Limited

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Elizabeth Kealy

Role: PRINCIPAL_INVESTIGATOR

Sleepmetrics

Locations

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SleepMetrics Pty Ltd

Melbourne, Victoria, Australia

Site Status

Countries

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Australia

Other Identifiers

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SOMFIT02

Identifier Type: -

Identifier Source: org_study_id