Obstructive Sleep ApneaNCT05018234
Safety Monitoring for a Novel 3D Printed Mandibular Advancement Device
A study testing Noval Oral Appliance in people with Obstructive Sleep Apnea, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the safety profile of the novel oral appliance (OA )device and to assess patient comfort of the novel OA device. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- Noval Oral Appliance
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Aug 2021to 1 Apr 2022
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- No history of obstructive sleep apnea
- No active jaw joint pain
- No active moderate to severe periodontal disease
- Presence of 12 teeth per arch
Who cannot join
- presence of severe bruxism
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
About this study
The purpose of this study is to evaluate the safety profile of the novel oral appliance (OA )device and to assess patient comfort of the novel OA device.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- Noval Oral Appliance
- Keywords
- oral appliance, sleep apnea, hypoxia
- Medical subject headings
- Sleep Apnea, Obstructive, Sleep Apnea Syndromes, Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Noval Oral ApplianceDevice
A scan of the mouth will be performed to make the oral device. The device will be 3D printed with Asiga UV Max printer using FDA 510(k) cleared VeriSplint OS Resin.Subjects will be will be asked to wear the oral device at night for 3 nights and fill out a survey reviewing their experience wearing the device.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Not described Receives: Device: Noval Oral Appliance |
What is being measured
The primary outcome is the main question the study is designed to answer.
safety of device as measured by the number of patients with adverse events
Measured: During the time the OA device is worn, that is, from the time of appointment 2(1 month after enrollment) to the time of appointment 3 (1 week after appointment 2)"
Secondary outcomes (2)
Comfort of the novel OA device as measured by the delivery (pre care) patient feedback survey
Comfort will be assessed through a numerical rating scale and short answer survey that will assess comfort and user feedback while wearing the novel OA device. There are 4 questions in the survey, the first one has 5 answer choices about how the appliance fits to the teeth and ranges from very tight fit to very loose fit .The rest of the questions are rated form 1-10,a higher number indicating more comfort
Measured: 1 month after enrollment(appointment 2)
Comfort of the novel OA device as measured by the post care patient feedback survey
Comfort will be assessed through a numerical rating scale and short answer survey that will assess comfort and user feedback while wearing the novel OA device.There are 12 questions in the survey, the first one has 5 answer choices about how the appliance fits to the teeth and ranges from very tight fit to very loose fit .The next 8 questions are rated form 1-10,a higher number indicating more comfort, the 9th question indicates any adverse events and the last 3 questions are short answer questions describing the patient's experience with the device.
Measured: 1 week after appointment 2(appointment 3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2021
- Study start4 Aug 2021
- Primary completion1 Mar 2022
- Study completion1 Apr 2022
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.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- 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
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aaron Glick, The University of Texas Health Science Center, Houston
- Investigators
- Aaron Glick, DDS, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05018234
- Sponsor's protocol ID
- HSC-DB-21-0472
- Status last verified
- May 2022
- First submitted
- 18 Aug 2021
- Last updated
- 25 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety Monitoring for a Novel 3D Printed Mandibular Advancement Device
- ClinicalTrials.gov ID
- NCT05018234
- Acronym / sponsor ID
- HSC-DB-21-0472
- Conditions
- Obstructive Sleep Apnea
- Keywords
- oral appliance, sleep apnea, hypoxia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- 4 Aug 2021 (actual)
- Primary completion
- 1 Mar 2022 (actual)
- Study completion
- 1 Apr 2022 (actual)
- First posted
- 24 Aug 2021 (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.
The purpose of this study is to evaluate the safety profile of the novel oral appliance (OA )device and to assess patient comfort of the novel OA device.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Device: Noval Oral Appliance |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- No history of obstructive sleep apnea
- No active jaw joint pain
- No active moderate to severe periodontal disease
- Presence of 12 teeth per arch
Key exclusion criteria (1 listed)
- presence of severe bruxism
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 |
|---|---|---|
| Noval Oral ApplianceA scan of the mouth will be performed to make the oral device. The device will be 3D printed with Asiga UV Max printer using FDA 510(k) cleared VeriSplint OS Resin.Subjects will be will be asked to wear the oral device at night for 3 nights and fill out a survey reviewing their experience wearing the device. | Device | Treatment |
Primary outcome
safety of device as measured by the number of patients with adverse events
Time frame: During the time the OA device is worn, that is, from the time of appointment 2(1 month after enrollment) to the time of appointment 3 (1 week after appointment 2)"
2 secondary outcomes
Comfort of the novel OA device as measured by the delivery (pre care) patient feedback survey
Time frame: 1 month after enrollment(appointment 2)
Comfort of the novel OA device as measured by the post care patient feedback survey
Time frame: 1 week after appointment 2(appointment 3)
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 25 May 2022.
- 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.
Aaron Glick, DDS principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Noval Oral Appliance in people with Obstructive Sleep Apnea, run by The University of Texas Health Science Center, Houston 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 1 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 25 May 2022. 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?
safety of device as measured by the number of patients with adverse events (time frame: During the time the OA device is worn, that is, from the time of appointment 2(1 month after enrollment) to the time of appointment 3 (1 week after appointment 2)"). 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 25 May 2022.