Obstructive Sleep ApneaNCT03579225
Improving the Efficiency of the Digital Sleep Workflow Using MATRx Plus
An observational study of Obstructive Sleep Apnea, run by Zephyr Sleep Technologies at 1 site in United States.
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 18 years and older
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- MATRx plus test
- Type of treatment
- Pill or oral medicine, Medical device
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2018to 14 Apr 2019
- 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 18 years and older
- All sexes
- Adult, Older adult
Study population: Study participants will be recruited from the Principal Investigator's population of patients.
Who may be able to join
- 18 years of age
- suitable for oral appliance therapy
- ability to understand and provide informed consent
- ability and willingness to meet the required schedule
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this 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 pulls the lower jaw forward, opening the airway and allowing normal breathing.
Oral appliance treatment does not treat sleep apnea effectively in all patients. To identify patients for whom oral appliance therapy will work, Zephyr Sleep Technologies invented a device that tests various positions of the lower jaw from the comfort of your own home. The MATRx plus device is considered investigational since it has not been cleared by the U.S. FDA. During the MATRx plus test, the patient sleeps with a motorized positioner that moves the lower jaw. Jaw movement is automatically controlled by a computer, making the device a feedback controlled mandibular positioner.
The purpose of the study is to test the workflow of the MATRx plus feedback controlled mandibular positioner in its intended setting. The workflow includes recruitment into the study, the screening process, visits at the dentist, home sleep tests, and the decision made regarding oral appliance therapy based on the results of the sleep tests. The main objective is to determine the turnaround time of a MATRx plus test in a real-use dental setting.
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 of 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 pulls the lower jaw forward, opening the airway and allowing normal breathing.
Oral appliance treatment does not treat sleep apnea effectively in all patients. To identify patients for whom oral appliance therapy will work, Zephyr Sleep Technologies has invented a remotely controlled device that tests various positions of the lower jaw. This commercially available device, MATRx, is a U.S. Food and Drug Administration (FDA)-cleared motorized positioner that is used in an overnight sleep study performed in the hospital or clinic.
During the test, temporary dental impression trays cover the upper and lower teeth. These are attached to a small motor that slowly and gently pulls the lower jaw forward under the control of a technician who determines when the best position is reached. Knowing the best position and the likelihood of therapy success allows the dentist to build an oral appliance with confidence.
To eliminate the need for an overnight in-hospital study, Zephyr Sleep Technologies has invented a new investigational device that allows us to decide if patients are likely to benefit from oral appliance therapy from the comfort of the patient's own home. An investigational device is one that is not cleared by the U.S. FDA. Like MATRx, the patient sleeps with a motorized positioner that moves the lower jaw. However, the new device (MATRx plus) is automatically controlled by a computer, rather than a sleep technician, making it a feedback controlled mandibular positioner.
We have previously carried out four research studies leading to the development of this feedback controlled mandibular positioner. The first study showed that the technician-controlled positioner was able to accurately identify patients who were suitable for oral appliance therapy. This study also identified the amount of jaw protrusion needed to provide therapeutic relief of the patients' sleep apnea. This trial resulted in the placement of the MATRx device on the market. The other three trials showed that the feedback-controlled software used by the new positioner 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 research studies. Participants reported minor tooth and gum discomfort on the morning following the test and other minor issues, including excess saliva and being unable to sleep. Since other studies were designed to establish the safety and efficacy of the device, the purpose of the present research study is to collect data regarding the use of the device in its intended commercial setting, i.e., the dentist's office.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- MATRx plus test
- 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 plus testDevice
The MATRx plus is a home-based test that allows the healthcare provider to determine if a patient with obstructive sleep apnea will benefit from oral appliance therapy. Prior to the test, a dentist fits the patient with dental trays and measures the patient's comfortable jaw range of motion. The trays are connected to a mandibular positioner. During sleep, the device collects airflow from a nasal cannula and blood oxygen saturation from a pulse oximeter. These signals are used by the device software to control the mandibular positioner and protrude the mandible. During the test, the device moves the lower jaw within the patient's range of motion to predict if the patient is likely to benefit from oral appliance therapy and, if so, the appropriate amount of protrusion. Additional study nights may be required if the data from either of the first two nights are insufficient or if a more precise determination of the amount of jaw protrusion that provided a therapeutic benefit can be made.
| Study group | Role | What they receive |
|---|---|---|
| MATRx plus test | Not described Receives: Device: MATRx plus test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Device turnaround time
Time from device deployment for MATRx plus test to device return (days).
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2018
- Study start1 Jul 2018
- Primary completion14 Apr 2019
- Study completion14 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 6 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
- NCT03579225
- Sponsor's protocol ID
- ZCP201801
- Status last verified
- Apr 2019
- First submitted
- 25 Jun 2018
- Last updated
- 18 Apr 2019
- Results posted
- No
- FDA-regulated drug
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving the Efficiency of the Digital Sleep Workflow Using MATRx Plus
- ClinicalTrials.gov ID
- NCT03579225
- Acronym / sponsor ID
- ZCP201801
- Conditions
- Obstructive Sleep Apnea
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Zephyr Sleep TechnologiesIndustry (pharma, biotech, devices)
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 14 Apr 2019 (actual)
- Study completion
- 14 Apr 2019 (actual)
- First posted
- 6 Jul 2018 (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 pulls the lower jaw forward, opening the airway and allowing normal breathing.
Oral appliance treatment does not treat sleep apnea effectively in all patients. To identify patients for whom oral appliance therapy will work, Zephyr Sleep Technologies invented a device that tests various positions of the lower jaw from the comfort of your own home. The MATRx plus device is considered investigational since it has not been cleared by the U.S. FDA. During the MATRx plus test, the patient sleeps with a motorized positioner that moves the lower jaw. Jaw movement is automatically controlled by a computer, making the device a feedback controlled mandibular positioner.
The purpose of the study is to test the workflow of the MATRx plus feedback controlled mandibular positioner in its intended setting. The workflow includes recruitment into the study, the screening process, visits at the dentist, home sleep tests, and the decision made regarding oral appliance therapy based on the results of the sleep tests. The main objective is to determine the turnaround time of a MATRx plus test in a real-use dental setting.
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 of 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 pulls the lower jaw forward, opening the airway and allowing normal breathing.
Oral appliance treatment does not treat sleep apnea effectively in all patients. To identify patients for whom oral appliance therapy will work, Zephyr Sleep Technologies has invented a remotely controlled device that tests various positions of the lower jaw. This commercially available device, MATRx, is a U.S. Food and Drug Administration (FDA)-cleared motorized positioner that is used in an overnight sleep study performed in the hospital or clinic.
During the test, temporary dental impression trays cover the upper and lower teeth. These are attached to a small motor that slowly and gently pulls the lower jaw forward under the control of a technician who determines when the best position is reached. Knowing the best position and the likelihood of therapy success allows the dentist to build an oral appliance with confidence.
To eliminate the need for an overnight in-hospital study, Zephyr Sleep Technologies has invented a new investigational device that allows us to decide if patients are likely to benefit from oral appliance therapy from the comfort of the patient's own home. An investigational device is one that is not cleared by the U.S. FDA. Like MATRx, the patient sleeps with a motorized positioner that moves the lower jaw. However, the new device (MATRx plus) is automatically controlled by a computer, rather than a sleep technician, making it a feedback controlled mandibular positioner.
We have previously carried out four research studies leading to the development of this feedback controlled mandibular positioner. The first study showed that the technician-controlled positioner was able to accurately identify patients who were suitable for oral appliance therapy. This study also identified the amount of jaw protrusion needed to provide therapeutic relief of the patients' sleep apnea. This trial resulted in the placement of the MATRx device on the market. The other three trials showed that the feedback-controlled software used by the new positioner 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 research studies. Participants reported minor tooth and gum discomfort on the morning following the test and other minor issues, including excess saliva and being unable to sleep. Since other studies were designed to establish the safety and efficacy of the device, the purpose of the present research study is to collect data regarding the use of the device in its intended commercial setting, i.e., the dentist's office.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MATRx plus test | – | Device: MATRx plus test |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Study participants will be recruited from the Principal Investigator's population of patients.
Key inclusion criteria (4 listed)
- 18 years of age
- suitable for oral appliance therapy
- ability to understand and provide informed consent
- ability and willingness to meet the required schedule
Key exclusion criteria (0 listed)
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 plus testThe MATRx plus is a home-based test that allows the healthcare provider to determine if a patient with obstructive sleep apnea will benefit from oral appliance therapy. Prior to the test, a dentist fits the patient with dental trays and measures the patient's comfortable jaw range of motion. The trays are connected to a mandibular positioner. During sleep, the device collects airflow from a nasal cannula and blood oxygen saturation from a pulse oximeter. These signals are used by the device software to control the mandibular positioner and protrude the mandible. During the test, the device moves the lower jaw within the patient's range of motion to predict if the patient is likely to benefit from oral appliance therapy and, if so, the appropriate amount of protrusion. Additional study nights may be required if the data from either of the first two nights are insufficient or if a more precise determination of the amount of jaw protrusion that provided a therapeutic benefit can be made. | Device | MATRx plus test |
Primary outcome
Device turnaround time
Time frame: 1 week
Time from device deployment for MATRx plus test to device return (days).
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 18 Apr 2019.
- 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 United States.
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 4 inclusion and 0 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 18 Apr 2019. 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 United States. 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?
Device turnaround time (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Apr 2019.