Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03627169 |
| Other study ID # |
ZCP201704 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
July 25, 2017 |
| Est. completion date |
July 3, 2019 |
Study information
| Verified date |
March 2021 |
| Source |
Zephyr Sleep Technologies |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
Description:
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.
OSA derives fundamentally from structural abnormalities of the pharynx that cause pharyngeal
narrowing or closure during sleep and produce recurrent apneas and hypopneas. During
wakefulness, compensatory neuromuscular reflexes protect the pharynx from collapse. These
reflexes are lost during sleep, leaving the collapsible human pharynx susceptible to
narrowing or closure. Owing largely to its association with excess body weight, OSA has
arguably become the most prevalent chronic non-communicable disease in industrialized
societies, assuming that obesity is not classified a disease. In addition to impairing
quality of life, OSA conveys an increased risk of cardiovascular disease and vehicular
accidents. The majority of apneics remain undiagnosed and untreated. Thus, OSA has the
hallmarks of a major public health problem, affecting all age groups and increasing in
epidemic proportions. Unfortunately, current medical practices seem ill-suited to dealing
with the challenges posed by OSA.
Perhaps the most unsettling aspect of present medical practices relates to the cumbersome,
uninviting, and expensive methods currently used to diagnose the disease. Common clinical
experience indicates that individuals often resist undergoing the standard diagnostic test,
an overnight in-hospital polysomnogram (PSG), because of the extensive attachments to the
body surface. In other words, as public awareness of sleep apnea has increased so also has
the negative impression of current testing. Any effective solution to the public health
challenges posed by sleep apnea will have to consider the need for less cumbersome and
off-putting clinical methods.
Zephyr Sleep Technologies has developed a device that has been approved for use in Canada.
The device, MATRx plus, 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.
Once the participant arrives at the PSG laboratory, the clinical coordinator will obtain
written informed consent, review inclusion and exclusion criteria, and enroll eligible
participants into the study. The clinical coordinator will give the participant a brief
overview on use of the MATRx plus Level III sleep recorder, then return to the control room
to watch the participant set up the device via video. The participant will be made aware of
the video recorded during set up the MATRx plus device. The device set up consists of: dual
nares nasal cannula for airflow, respiratory effort belt, pulse oximeter, snoring (recorded
via airflow frequency on the nasal cannula and via sound on the tablet), body position from
an accelerometer built into the body-worn recorder. The sleep technician will then set the
participant up with a standard PSG montage, consisting of: electroencephalogram (EEG),
electrooculogram (EOG), electromyogram (EMG), pulse oximeter, nasal cannula, two respiratory
effort belts, snoring, and body position (recorded via body-mounted accelerometer). Once the
participant has both the MATRx plus and the PSG montage set up, the study will commence, and
the participant will be monitored by video from the PSG control room, as is standard practice
in a PSG. The sleep technician will intervene as necessary to ensure adequate signals are
collected by the PSG equipment.
