Obstructive Sleep ApneaNCT03812692
Validation of a Simplified MATRx Plus
An observational study of Obstructive Sleep Apnea, run by Zephyr Sleep Technologies at 1 site in Canada.
Trial summary
Sleep apnea (OSA) is a condition in which the air passage in the throat closes or partly closes during sleep and repeatedly interrupts breathing. The standard treatment for sleep apnea is continuous positive airway pressure (CPAP), but it is not suitable for all patients. Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- MATRx plus
- Type of treatment
- Pill or oral medicine, Medical device
- How many people
- 59 participants
- Where
- 1 siteCanada
- Study dates
- 6 Feb 2019to 1 Mar 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will be representative of the general population of individuals with obstructive sleep apnea in North America.
Who may be able to join
- Aged between 21 and 80 years
- Obstructive sleep apnea (ODI > 10 h-1)
- Body mass index < 45 kg/m2
- Neck circumference < 50 cm
- Absence of severe oxyhemoglobin desaturation during sleep, indicated by a mean value of oxyhemoglobin saturation (SaO2) > 87%
- Mandibular range of motion > 5 mm
Show all 9Show fewer
- Adequate dentition (10 upper and 10 lower teeth)
- Ability to understand and provide informed consent
- Ability and willingness to meet the required schedule
Who cannot join
- Inability to breathe comfortably through the nose
- Central Sleep Apnea (> 50% of apneas are central)
- Anticipated change in medical therapy that could alter the severity of OSA during the protocol
- Anticipated change in body weight (5% or more) during the protocol
- Symptomatic, non-respiratory sleep disorder, e.g., restless leg syndrome or chronic insomnia
- Severe respiratory disorder(s) other than sleep disordered breathing
Show all 13Show fewer
- Loose teeth, faulty restorations, or advanced periodontal disease
- Participation in other studies that could interfere with study protocol
- Pregnant or nursing
- Heart failure
- Cerebral vascular incident within the last 12 months
- Use of pacemaker or other life supporting device
- Regular use of CPAP or oral appliance therapy within 5 days of the PSG or HSAT (individuals on therapy wishing to participate may opt to cease therapy for the 5 nights prior to each test)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Validation of a Simplified MATRx Plus Theragnostic Sleep Study
Sleep apnea (OSA) is a condition in which the air passage in the throat closes or partly closes during sleep and repeatedly interrupts breathing. The standard treatment for sleep apnea is continuous positive airway pressure (CPAP), but it is not suitable for all patients. Another treatment is to use an oral appliance in your mouth when you sleep. The appliance covers the upper and lower teeth and acts to pull the lower jaw forward, opening the throat passage and allowing normal breathing.
Oral appliance therapy does not treat sleep apnea effectively in everyone. In order to identify the people in whom oral appliance therapy will work, Zephyr Sleep Technologies has invented a feedback-controlled device that tests various positions of the lower jaw. This commercially available device, known as MATRx plus, is a Health Canada approved and FDA cleared motorized dental positioner that can be used in an overnight sleep study performed in the home. Temporary dental impression trays cover your upper and lower teeth. These are attached to a small motor that slowly and gently pulls your lower jaw forward under the control of a computer in response to real-time breathing events. The commercial MATRx plus device uses measures of airflow from a nasal cannula and blood oxygen saturation from a pulse oximeter to guide the movement of the lower jaw during the test. Though the test is accurate, the equipment can be somewhat cumbersome to apply. The purpose of the study is to validate a simplified version of the test that requires fewer sensors and sleep time.
Read the detailed description
Sleep apnea (OSA) is a condition in which the air passage in the throat closes or partly closes during sleep and repeatedly interrupts breathing. The standard treatment for sleep apnea is continuous positive airway pressure (CPAP), but it is not suitable for all patients. Another treatment is to use an oral appliance in your mouth when you sleep. The appliance covers the upper and lower teeth and acts to pull the lower jaw forward, opening the throat passage and allowing normal breathing.
Oral appliance therapy does not treat sleep apnea effectively in everyone. In order to identify the people in whom oral appliance therapy will work, Zephyr Sleep Technologies has invented a feedback-controlled device that tests various positions of the lower jaw. This commercially available device, known as MATRx plus, is a Health Canada approved and FDA cleared motorized dental positioner that can be used in an overnight sleep study performed in the home. Temporary dental impression trays cover your upper and lower teeth. These are attached to a small motor that slowly and gently pulls your lower jaw forward under the control of a computer in response to real-time breathing events. The commercial MATRx plus device uses measures of airflow from a nasal cannula and blood oxygen saturation from a pulse oximeter to guide the movement of the lower jaw during the test. Though the test is accurate, the equipment can be somewhat cumbersome to apply. The purpose of the study is to validate a simplified version of the test that requires fewer sensors and sleep time.
We have previously carried out three research studies leading to the development of the feedback-controlled mandibular positioner. These studies, two of which used early prototypes of the device and one that used the commercial MATRx plus device, showed that the feedback-control software used was very accurate and was able to identify successful candidates in a home setting.
No serious or permanent problems or risks were identified in any of the previous research studies. Participants reported minor tooth and gum discomfort on the morning following the test and other minor issues including dry mouth, excessive saliva, and being unable to sleep. The previous studies have established the safety and efficacy of the device using a device prototype. The purpose of the present study is to determine if the efficacy of the device is maintained when fewer sensors are used and the requirement for sleep time is reduced.
The study will collect data over one night in a sleep laboratory and a series of nights in the home. Following the study, you will be told if you are a suitable candidate for oral appliance therapy. If you do not already have a custom oral appliance, one will be provided to you. During the study, the Principal Investigator and study dentist will be blinded to the results of your tests. In the event of an emergency, the Principal Investigator can be unblinded to your test results.
Up to 46 individuals will be recruited for this study. Study participants will need to attend visits at multiple centres located in Calgary, Alberta.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- MATRx plus
- Keywords
- Oral appliance therapy
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MATRx plusDevice
The MATRx plus device is a feedback-controlled mandibular positioner that uses data collected during sleep to control movement of the mandible in real-time using a mandibular positioner. The test provides a prediction of the individual's response to oral appliance therapy; i.e., if the individual can treat his or her obstructive sleep apnea using a mandibular advancing oral appliance. For individuals predicted to respond to the therapy, the test also provides a mandibular position at which the appliance will be effective.
| Study group | Role | What they receive |
|---|---|---|
| MATRx plus test | All participants will complete the MATRx plus test unattended in the home. Not all participants will be predicted responders to oral appliance therapy; both predicted responders and non-responders will undergo an outcome home sleep apnea test with a custom oral appliance in place to validate the prediction made by the test. Twenty participants will also complete an in-lab sleep study prior to the home study. Receives: Device: MATRx plus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxygen desaturation index
With the oral appliance in place, participants will complete a 2-night home sleep apnea test with a Level III sleep recorder. The participant's oxygen desaturation index with the appliance will be recorded.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2019
- Study start6 Feb 2019
- Primary completion15 Mar 2020
- Study completion1 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zephyr Sleep Technologies
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03812692
- Sponsor's protocol ID
- ZCP201901
- Status last verified
- Mar 2021
- First submitted
- 18 Jan 2019
- Last updated
- 4 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Mosca EV, Grosse J, Remmers JE. Oral appliance therapy is highly efficacious at reducing sleep apnea-specific hypoxic burden, a metric predictive of cardiovascular morbidity and mortality. J Clin Sleep Med. 2025 Jul 1;21(7):1185-1190. doi: 10.5664/jcsm.11622.
PubMed 40123555
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of a Simplified MATRx Plus Theragnostic Sleep Study
- ClinicalTrials.gov ID
- NCT03812692
- Acronym / sponsor ID
- ZCP201901
- Conditions
- Obstructive Sleep Apnea
- Keywords
- Oral appliance therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Zephyr Sleep TechnologiesIndustry (pharma, biotech, devices)
- Study start
- 6 Feb 2019 (actual)
- Primary completion
- 15 Mar 2020 (actual)
- Study completion
- 1 Mar 2021 (actual)
- First posted
- 23 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Sleep apnea (OSA) is a condition in which the air passage in the throat closes or partly closes during sleep and repeatedly interrupts breathing. The standard treatment for sleep apnea is continuous positive airway pressure (CPAP), but it is not suitable for all patients. Another treatment is to use an oral appliance in your mouth when you sleep. The appliance covers the upper and lower teeth and acts to pull the lower jaw forward, opening the throat passage and allowing normal breathing.
Oral appliance therapy does not treat sleep apnea effectively in everyone. In order to identify the people in whom oral appliance therapy will work, Zephyr Sleep Technologies has invented a feedback-controlled device that tests various positions of the lower jaw. This commercially available device, known as MATRx plus, is a Health Canada approved and FDA cleared motorized dental positioner that can be used in an overnight sleep study performed in the home. Temporary dental impression trays cover your upper and lower teeth. These are attached to a small motor that slowly and gently pulls your lower jaw forward under the control of a computer in response to real-time breathing events. The commercial MATRx plus device uses measures of airflow from a nasal cannula and blood oxygen saturation from a pulse oximeter to guide the movement of the lower jaw during the test. Though the test is accurate, the equipment can be somewhat cumbersome to apply. The purpose of the study is to validate a simplified version of the test that requires fewer sensors and sleep time.
Detailed description
Sleep apnea (OSA) is a condition in which the air passage in the throat closes or partly closes during sleep and repeatedly interrupts breathing. The standard treatment for sleep apnea is continuous positive airway pressure (CPAP), but it is not suitable for all patients. Another treatment is to use an oral appliance in your mouth when you sleep. The appliance covers the upper and lower teeth and acts to pull the lower jaw forward, opening the throat passage and allowing normal breathing.
Oral appliance therapy does not treat sleep apnea effectively in everyone. In order to identify the people in whom oral appliance therapy will work, Zephyr Sleep Technologies has invented a feedback-controlled device that tests various positions of the lower jaw. This commercially available device, known as MATRx plus, is a Health Canada approved and FDA cleared motorized dental positioner that can be used in an overnight sleep study performed in the home. Temporary dental impression trays cover your upper and lower teeth. These are attached to a small motor that slowly and gently pulls your lower jaw forward under the control of a computer in response to real-time breathing events. The commercial MATRx plus device uses measures of airflow from a nasal cannula and blood oxygen saturation from a pulse oximeter to guide the movement of the lower jaw during the test. Though the test is accurate, the equipment can be somewhat cumbersome to apply. The purpose of the study is to validate a simplified version of the test that requires fewer sensors and sleep time.
We have previously carried out three research studies leading to the development of the feedback-controlled mandibular positioner. These studies, two of which used early prototypes of the device and one that used the commercial MATRx plus device, showed that the feedback-control software used was very accurate and was able to identify successful candidates in a home setting.
No serious or permanent problems or risks were identified in any of the previous research studies. Participants reported minor tooth and gum discomfort on the morning following the test and other minor issues including dry mouth, excessive saliva, and being unable to sleep. The previous studies have established the safety and efficacy of the device using a device prototype. The purpose of the present study is to determine if the efficacy of the device is maintained when fewer sensors are used and the requirement for sleep time is reduced.
The study will collect data over one night in a sleep laboratory and a series of nights in the home. Following the study, you will be told if you are a suitable candidate for oral appliance therapy. If you do not already have a custom oral appliance, one will be provided to you. During the study, the Principal Investigator and study dentist will be blinded to the results of your tests. In the event of an emergency, the Principal Investigator can be unblinded to your test results.
Up to 46 individuals will be recruited for this study. Study participants will need to attend visits at multiple centres located in Calgary, Alberta.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MATRx plus test | – | Device: MATRx plusAll participants will complete the MATRx plus test unattended in the home. Not all participants will be predicted responders to oral appliance therapy; both predicted responders and non-responders will undergo an outcome home sleep apnea test with a custom oral appliance in place to validate the prediction made by the test. Twenty participants will also complete an in-lab sleep study prior to the home study. |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will be representative of the general population of individuals with obstructive sleep apnea in North America.
Key inclusion criteria (9 listed)
- Aged between 21 and 80 years
- Obstructive sleep apnea (ODI > 10 h-1)
- Body mass index < 45 kg/m2
- Neck circumference < 50 cm
- Absence of severe oxyhemoglobin desaturation during sleep, indicated by a mean value of oxyhemoglobin saturation (SaO2) > 87%
Key exclusion criteria (13 listed)
- Inability to breathe comfortably through the nose
- Central Sleep Apnea (> 50% of apneas are central)
- Anticipated change in medical therapy that could alter the severity of OSA during the protocol
- Anticipated change in body weight (5% or more) during the protocol
- Symptomatic, non-respiratory sleep disorder, e.g., restless leg syndrome or chronic insomnia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MATRx plusThe MATRx plus device is a feedback-controlled mandibular positioner that uses data collected during sleep to control movement of the mandible in real-time using a mandibular positioner. The test provides a prediction of the individual's response to oral appliance therapy; i.e., if the individual can treat his or her obstructive sleep apnea using a mandibular advancing oral appliance. For individuals predicted to respond to the therapy, the test also provides a mandibular position at which the appliance will be effective. | Device | MATRx plus test |
Primary outcome
Oxygen desaturation index
Time frame: 6 weeks
With the oral appliance in place, participants will complete a 2-night home sleep apnea test with a Level III sleep recorder. The participant's oxygen desaturation index with the appliance will be recorded.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2021.
- Derived from this study: PubMed 40123555Mosca EV, Grosse J, Remmers JE. Oral appliance therapy is highly efficacious at reducing sleep apnea-specific hypoxic burden, a metric predictive of cardiovascular morbidity and mortality. J Clin Sleep Med. 2025 Jul 1;21(7):1185-1190. doi: 10.5664/jcsm.11622.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obstructive Sleep Apnea, run by Zephyr Sleep Technologies at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oxygen desaturation index (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03812692, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2021; AzTrials last refreshed its copy on 30 Oct 2026.