Comparative Assessment of Compumedics Somfit Sleep Monitoring Device

NCT05647746 | Completed

• 1 other identifier: AJ259
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Sleep-Disordered Breathing

Outcome Measures

Primary Outcomes (2)

• The AHI difference between the test device (Somfit) and gold standard (PSG)

  AHI is the apnea hypopnea index, main measure of presence/severity of OSA (obstructive sleep apnea). it will test the null hypothesis that Somfit AHI is not equivalent to the AHI reported by PSG

  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

• The AHI difference between the test device (Somfit) and predicate device (WatchPAT)

  AHI is the apnea hypopnea index, main measure of presence/severity of OSA (obstructive sleep apnea). it will test the null hypothesis that Somfit AHI is not equivalent to the AHI reported by PSG

  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 (2)

• Difference between hypnogram percent agreements between WatchPAT and PSG, and between Somfit and PSG

  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

• Hypnogram percent agreement between Somfit and PSG

  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 (3)

• Respiratory Event Index (REI) for Somfit

  The measure will be calculated for every participant following a single night sleep recording

• Oxygen Desaturation Index (ODI) for Somfit

  The measure will be calculated for every participant following a single night sleep recording

• Average pulse rate (PR) for Somfit

  The measure will be calculated for every participant following a single night sleep recording

Interventions

Compumedics Somfit HSAT device, WatchPAT HSAT device, Compumedics Grael /E-series PSG system DEVICE

Each intervention is a separate diagnostic device. They will all be operating at the same time

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Compumedics Limited: lead

Study Sites (1)

SleepMetrics Pty Ltd

Heidelberg, VUC, 3084, 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 Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The sleep technologists who assess the sleep study outcomes will be blinded to the device generating the diagnostic data
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: December 1, 2022
• First Posted: December 12, 2022
• Study Start: December 10, 2022
• Primary Completion: February 28, 2023
• Study Completion: May 31, 2023
• Last Updated: February 7, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)