Evaluation of Compumedics "Somfit" Device

Compumedics

Status: Completed

Conditions: Sleep Apnea

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

Study type: Observational

Funder types: Industry

Identifiers

NCT04326127

SOMFIT02

Details and patient eligibility

About

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

Full 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 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.

Enrollment: 30 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

30 participants in 2 patient groups

Control

Description:

Healthy volunteers

Treatment:

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

Case

Description:

Volunteers with diagnosed sleep apnea

Treatment:

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