Obstructive Sleep ApneaNCT02933112
Workflow Validation of an In-home Auto-titrating Mandibular Positioner
A study testing Auto-titrating mandibular positioner test in people with Obstructive Sleep Apnea, run by Zephyr Sleep Technologies at 1 site in United States.
Trial summary
The purpose of the study is to test the workflow of an auto-titrating mandibular positioner in its intended setting. Participants with obstructive sleep apnea will use the device to determine their eligibility for oral appliance therapy and provide feedback on usability of the device. 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?
- Auto-titrating mandibular positioner test
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2016to 11 Oct 2018
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Minimum 18 years of age
- Participant has been deemed suitable for oral appliance therapy
- Prescription for oral appliance
- Adequate range of motion
- Adequate dentition
- Ability to understand and provide informed consent
- Ability and willingness to meet the required schedule
Who cannot join
- Loose teeth or advanced periodontal disease
- Full dentures or dental implants
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of the study is to test the workflow of an auto-titrating mandibular positioner in its intended setting. Participants with obstructive sleep apnea will use the device to determine their eligibility for oral appliance therapy and provide feedback on usability of the device.
Read the detailed description
One treatment for obstructive sleep apnea is oral appliance therapy during sleep, in which an appliance that covers the upper and lower teeth acts to pull the lower jaw forward, opening the throat passage and allowing for normal breathing. However, oral appliance therapy does not treat sleep apnea effectively in all individuals. In order to identify those individuals for whom oral appliance therapy will work, the study sponsor has developed an investigational device called an auto-titrating mandibular positioner. The device automatically pulls the lower jaw forward in response to respiratory events while the individual sleeps. Study participants will learn the outcome of their sleep tests and will provide feedback on the ease of use of the device.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- Auto-titrating mandibular positioner test
- 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.
Auto-titrating mandibular positioner testDevice
Participants will undergo a theragnostic test using the auto-titrating mandibular positioner to determine if they are eligible candidates to use oral appliance therapy for their obstructive sleep apnea. The device works by moving the lower jaw forward in response to respiratory events while the participant sleeps. All participants will undergo the same test.
| Study group | Role | What they receive |
|---|---|---|
| AMP test group | Other | All individuals will undergo a test using the auto-titrating mandibular positioner. Receives: Device: Auto-titrating mandibular positioner test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Integration of the device into the existing workflow of a dental sleep medicine practice
Data for this outcome are largely directed at the study staff, not study participants. Data collected for this outcome include: time required to evaluate eligibility for device use, prepare device for use, and ease of scheduling of study visits
Measured: 1 year
Convenience and feasibility of carrying out a multi-night AMP study in the home
Participants will complete a questionnaire following their AMP tests to collect data on ease of use of the device and opinion of the various device components.
Measured: 1 year
Feasibility of instructing the participant on the use of the AMP device at the practitioner's office
Data for this outcome are directed at study staff, not study participants. Data collected will include feedback on ease of training participants on device use. Participants will be asked if they felt they received adequate training from the study staff via a questionnaire.
Measured: 1 year
Secondary outcomes (3)
Time to treatment
Time to treatment will be evaluated by tracking the time from the first consultation at the dentist's office to the setting of the temporary appliance (for individuals whose tests indicate they are predicted candidates for oral appliance therapy).
Measured: 1 year
Number of study visits
The number of study visits will be recorded. This data will be collected from study records and does not require input from the participant.
Measured: 1 year
Length of study visits
The length of each visit (minutes) will be recorded. This data will be collected from study records and does not require input from the participant.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2016 (estimated)
- Study startOct 2016
- Primary completion4 Sep 2018
- Study completion11 Oct 2018
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zephyr Sleep Technologies
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Stephen Carstensen, DDS, Principal investigator, Premier Sleep
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02933112
- Sponsor's protocol ID
- ZCP2015_02
- Status last verified
- Oct 2018
- First submitted
- 4 Oct 2016
- Last updated
- 17 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Workflow Validation of an In-home Auto-titrating Mandibular Positioner
- ClinicalTrials.gov ID
- NCT02933112
- Acronym / sponsor ID
- ZCP2015_02
- Conditions
- Obstructive Sleep Apnea
- Keywords
- Oral appliance therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Zephyr Sleep TechnologiesIndustry (pharma, biotech, devices)
- Study start
- Oct 2016
- Primary completion
- 4 Sep 2018 (actual)
- Study completion
- 11 Oct 2018 (actual)
- First posted
- 14 Oct 2016 (estimated)
- 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.
The purpose of the study is to test the workflow of an auto-titrating mandibular positioner in its intended setting. Participants with obstructive sleep apnea will use the device to determine their eligibility for oral appliance therapy and provide feedback on usability of the device.
Detailed description
One treatment for obstructive sleep apnea is oral appliance therapy during sleep, in which an appliance that covers the upper and lower teeth acts to pull the lower jaw forward, opening the throat passage and allowing for normal breathing. However, oral appliance therapy does not treat sleep apnea effectively in all individuals. In order to identify those individuals for whom oral appliance therapy will work, the study sponsor has developed an investigational device called an auto-titrating mandibular positioner. The device automatically pulls the lower jaw forward in response to respiratory events while the individual sleeps. Study participants will learn the outcome of their sleep tests and will provide feedback on the ease of use of the device.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AMP test group | Other | Device: Auto-titrating mandibular positioner testAll individuals will undergo a test using the auto-titrating mandibular positioner. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Minimum 18 years of age
- Participant has been deemed suitable for oral appliance therapy
- Prescription for oral appliance
- Adequate range of motion
- Adequate dentition
Key exclusion criteria (2 listed)
- Loose teeth or advanced periodontal disease
- Full dentures or dental implants
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 |
|---|---|---|
| Auto-titrating mandibular positioner testParticipants will undergo a theragnostic test using the auto-titrating mandibular positioner to determine if they are eligible candidates to use oral appliance therapy for their obstructive sleep apnea. The device works by moving the lower jaw forward in response to respiratory events while the participant sleeps. All participants will undergo the same test. | Device | AMP test group |
Primary outcome
Integration of the device into the existing workflow of a dental sleep medicine practice
Time frame: 1 year
Data for this outcome are largely directed at the study staff, not study participants. Data collected for this outcome include: time required to evaluate eligibility for device use, prepare device for use, and ease of scheduling of study visits
Convenience and feasibility of carrying out a multi-night AMP study in the home
Time frame: 1 year
Participants will complete a questionnaire following their AMP tests to collect data on ease of use of the device and opinion of the various device components.
Feasibility of instructing the participant on the use of the AMP device at the practitioner's office
Time frame: 1 year
Data for this outcome are directed at study staff, not study participants. Data collected will include feedback on ease of training participants on device use. Participants will be asked if they felt they received adequate training from the study staff via a questionnaire.
3 secondary outcomes
Time to treatment
Time frame: 1 year
Number of study visits
Time frame: 1 year
Length of study visits
Time frame: 1 year
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 17 Oct 2018.
- Individual participant dataSharing planned: No
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Supplemental Oxygen for Sleep-Disordered Breathing in Adults With Chronic Opioid Use.
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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.
Stephen Carstensen, DDS principal investigator
Premier Sleep
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Auto-titrating mandibular positioner test in people with 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 7 inclusion and 2 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 17 Oct 2018. 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?
Integration of the device into the existing workflow of a dental sleep medicine practice (time frame: 1 year). The study lists 3 primary outcomes in all. 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 17 Oct 2018.