Evaluation of Compumedics "Somfit" Device

NCT04326127 | Completed

• 1 other identifier: SOMFIT02
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Sleep Apnea

Outcome Measures

Primary Outcomes (1)

• Comparison between raw EEG signals

  Direct comparison of Raw EEG data between Somfit and Grael system on an epoch by epoch basis (with each epoch being equivalent to 30 secs) to test and validate Somfit for data acquisition, display and record of Raw EEG data.

  single night recording for each subject

Secondary Outcomes (1)

• Comparison between Manual and Automatic sleep Scoring - Sleep hypnogram

  single night recording for each subject

Other Outcomes (1)

• Validation of the new device for detection of sleep apnea

  single night recording for each subject

Study Arms (2)

Control

Healthy volunteers

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

Volunteers with diagnosed sleep apnea

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)

Interventions

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

Data were recorded overnight by both devices simultaneously

Case; Control

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

30 volunteers were invited to participate in this study. 15 participants will be selected among healthy volunteers, by advertising to the general public. The remaining 15 will be among patients with diagnosed sleep apnea who visit SleepMetrics clinic as part of their routine treatment.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Compumedics Limited: lead

Study Sites (1)

SleepMetrics Pty Ltd

Melbourne, Victoria, 3752, Australia

Location

MeSH Terms

Conditions

Sleep Apnea Syndromes

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Elizabeth Kealy

  Sleepmetrics

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2020
• First Posted: March 30, 2020
• Study Start: November 6, 2019
• Primary Completion: November 19, 2019
• Study Completion: November 19, 2019
• Last Updated: March 31, 2020

Record last verified: 2020-03

Locations

AU (1)