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PSG Validation of MATRx Plus AHI

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03627169
Recruitment Status : Active, not recruiting
First Posted : August 13, 2018
Last Update Posted : April 18, 2019
Sponsor:
Information provided by (Responsible Party):
Zephyr Sleep Technologies

Brief Summary:

Obstructive sleep apnea (OSA) is a common disease that carries significant risks for cardiovascular disease, mortality, and economic costs. Almost thirty years ago, initial population studies found the prevalence of OSA to be five to nine percent of the adult population. Excess body weight is a risk factor for the development of OSA, and the recent rise in prevalence of obesity has led to revised estimates of OSA prevalence, now at seventeen per cent of the adult population. OSA is poorly recognized clinically; 85% of apneics remain undiagnosed and untreated.

Currently, the diagnosis of OSA commonly relies on an overnight, in-hospital polysomnogram (PSG). Due to the extensive attachments to the body surface required in a PSG, it has developed a negative impression. Any effective solution to the public health challenges posed by sleep apnea will have to consider the need for less cumbersome and off-putting methods.

Zephyr Sleep Technologies has developed a device that has been approved for use in Canada. The MATRx plus device functions as both a Level III sleep recorder (records respiratory airflow, respiratory effort, pulse rate, and arterial oxygen saturation) as well as a home-based system to select patients for oral appliance therapy. The American Academy of Sleep Medicine (AASM) recommends the use of apnea-hypopnea index (AHI) for the diagnosis and categorization of OSA severity. The Level III function of the MATRx plus device is approved for use in Canada with two autoscoring methods: oxygen desaturation index, ODI and apnea-hypopnea index, AHI, but requires further validation of AHI for clearance by the US Food and Drug Administration (FDA).

The proposed research will validate the AHI autoscoring function of the MATRs plus Level III home sleep recorder by comparing it to data recorded in a PSG, which is considered to be the gold standard for sleep testing. Though the effectiveness of the AHI autoscoring algorithm has been previously established, it has not been validated against PSG data. Additionally, other parameters such as snoring will be examined in order to develop scoring algorithms for other facets of sleep disordered breathing.


Condition or disease Intervention/treatment
Obstructive Sleep Apnea Device: MATRx plus

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: PSG Validation of MATRx Plus AHI
Actual Study Start Date : July 25, 2017
Estimated Primary Completion Date : July 25, 2019
Estimated Study Completion Date : August 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

Group/Cohort Intervention/treatment
MATRx plus/PSG group
Healthy individuals, individuals suspected of having OSA, and individuals with a previous diagnosis of OSA will spend a single night in a sleep laboratory and undergo a standard polysomnogram simultaneously with a Level III sleep study using the MATRx plus device. There is no interventional aspect to the study.
Device: MATRx plus
The MATRx plus device will be used in its capacity as a Level III home sleep apnea test (HSAT). Note: MATRx plus is approved for use in Canada; therefore, the study does not involve any investigational devices.




Primary Outcome Measures :
  1. Apnea and hypopnea events [ Time Frame: 1 night ]
    The number of apnea and hypopnea events collected from each the MATRx plus device and PSG will be recorded in order to determine the sensitivity/specificity of the MATRx plus device.


Secondary Outcome Measures :
  1. Snoring events [ Time Frame: 1 night ]
    The number of snoring events



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Healthy individuals, individuals who suspect they may have OSA, and individuals who have previously been diagnosed with or treated for OSA will be recruited for the trial. Only participants who meet all eligibility criteria will be enrolled.
Criteria

Inclusion Criteria:

  • Aged between 21 and 80 years
  • Ability to understand and provide informed consent
  • Ability and willingness to meet the required schedule

Exclusion Criteria:

  • Inability to breathe comfortably through the nose
  • Symptomatic, non-respiratory sleep disorder, e.g., restless leg syndrome, chronic insomnia
  • Heart failure
  • Cerebral vascular incident within the last 12 months
  • Use of pacemaker or other life-supporting device

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03627169


Locations
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Canada, Alberta
Zephyr Sleep Technologies
Calgary, Alberta, Canada, T2H2C3
Sponsors and Collaborators
Zephyr Sleep Technologies
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Zephyr Sleep Technologies
ClinicalTrials.gov Identifier: NCT03627169    
Other Study ID Numbers: ZCP201704
First Posted: August 13, 2018    Key Record Dates
Last Update Posted: April 18, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: IPD will not be made available to other researchers.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Sleep Apnea, Obstructive
Sleep Apnea Syndromes
Apnea
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases