Obstructive Sleep ApneaBIMANCT03362671
Implant Supported Oral Appliance Treatment of OSA
A study testing Implant Supported Mandibular Advancement Oral Appliance and Orthodontic Mini Implant in people with Obstructive Sleep Apnea, run by University of British Columbia at 1 site in Canada.
Trial summary
Mandibular advancing oral appliances (OAm) are an effective and increasingly common treatment modality for the management of obstructive sleep apnea (OSA) in adults. The effectiveness of OAm therapy, however, is dependent on a high level of patient adherence, which may be negatively impacted by treatment side effects… Read more about this study
- Who is it for?
- Ages 25 to 65 years
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- Implant Supported Mandibular Advancement Oral Appliance and Orthodontic Mini Implant
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteCanada
- Study dates
- 1 Apr 2018to 11 Sep 2019
- 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 25 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- This trial will recruit 10 patients with an objective diagnosis of obstructive sleep apnea who are not naïve to treatment. The inclusion criteria are:
- Currently receive or have previously received successful OSA treatment with an OAm;
- Age 25 - 65 years old, who are able to freely provide informed consent;
- Body Mass Index (BMI) ≤ 35;
- Apnea-Hypopnea Index (AHI) within the range 5≤AHI≤50 documented with polysomnography in the last 2 years *OR*
- Respiratory Disturbance Index (RDI) within the range 20 ≤ RDI ≤ 50 documented with Level III portable sleep test *OR*
- Oxygen Desaturation Index (ODI) ≥ 10
Who cannot join
- The patient is excluded if it meets any of the following criteria:
- Extensive periodontal disease;
- Bleeding disorder;
- Bone metabolic disorder
- Immunocompromised
- Diabetes mellitus
Show all 16Show fewer
- Xerostomia
- Titanium allergy
- Insufficient vertical opening to accommodate treatment with OAm;
- Pregnancy (if a participant becomes pregnant during the trial, the participant will be withdrawn from the study).
- Uncontrolled congestive heart failure (defined as a prior clinical diagnosis, an ejection cut-off of 40% or clinical sign in the opinion of a primary care physician or cardiologist) that makes it unsafe in the opinion of the investigators for the subject to participate in the trial;
- Coronary artery disease unless stable for at least 6 months and considered by the investigators to have a stable disease;
- Any history of angina, myocardial infarction or stroke;
- Any history of major depressive disorder along with current moderate-severe disease;
- Active cancer management (unless in remission for more than 1 year);
- Known renal failure (with need for dialysis)
Trial locations and contacts
1 site in 1 country.
Canada1 site
University of British Columbia
Vancouver, British Columbia, V6T 1Z3
About this study
Official title: Bimaxillary Implant Supported Mandibular Advancement Pilot
Mandibular advancing oral appliances (OAm) are an effective and increasingly common treatment modality for the management of obstructive sleep apnea (OSA) in adults.
The effectiveness of OAm therapy, however, is dependent on a high level of patient adherence, which may be negatively impacted by treatment side effects - the most significant of which are occlusal changes and tooth movement.
Read more
The proposed pilot study will evaluate the efficacy of a novel implant supported OAm in 10 OSA patients who have already been successfully treated with a traditional OAm.
The study will compare OSA specific outcomes with traditional OAm use against novel oral appliance use after one month. This study could potentially validate the novel design features of an effective treatment option for OSA that does not result in tooth movement, which is a significant side effect shared by all existing OAm devices.
Ultimately, this study could lead to increased treatment adherence and better OSA patient health outcomes in the future.
Read the detailed description
Mandibular advancement oral appliances (OAm) are devices that keep the airway open during sleep by pulling the lower jaw forward. OAm have been shown to be an effective treatment for both mild and severe OSA. OSA is a chronic disease and there is no cure. OSA treatments depend on high patient adherence for long term effectiveness.
Currently marketed OAm devices attach to the teeth as a way of holding the jaw in position. However, attaching directly to the teeth causes unwanted tooth movement with long term OAm use. As a result, some long-term users of OAm have stopped treatment due to a decrease in quality of life caused by tooth movement. Accordingly, the changes in tooth position can be seen as a limitation of the existing appliances. For this reason, there is a strong need for a type of treatment that can effectively pull the jaw forward without causing movement of the teeth, which is inevitable with the way the current OAm devices work.
This trial is a pilot study to find out if a novel OAm device is an effective treatment for OSA. The novel OAm device does not contact the teeth directly but instead attaches to orthodontic mini implants (OMIs) in the jaw. 10 OSA patients who have previously been successfully treated with a traditional OAm appliance will be fitted with the novel oral appliance. Participants will be fitted with 6 OMIs following standard practice and the bespoke oral appliance will be manufactured and delivered to the patient for use.
Prior to receiving treatment, participants will undergo a baseline assessment where demographic, anthropometric, and specific periodontal health data will be collected. Daytime sleepiness will be assessed and at-home sleep test will be used to establish baseline sleep parameters with the existing appliance.
Follow up sleep tests will be completed 1 month after initiation of treatment with the new appliance. ESS questionnaires and treatment experience interviews will be completed at 1 month and 4 months after the start of treatment with the new appliance. Treatment adherence and OMI side effects will be monitored throughout the study. Patients will be given the option of continuing treatment with the novel device or having the implants removed and returning to treatment with their previous OAm.
To directly address the primary aim of this study, OSA related parameters will be measured by a combination of methods including at-home sleep tests and Epworth Sleepiness Scale (ESS) questionnaires. Secondary outcome variables to assess treatment adherence and satisfaction include self-reported adherence data using sleep diaries, experience interviews and assessing OMI side effects throughout the study.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- Implant Supported Mandibular Advancement Oral Appliance, Orthodontic Mini Implant
- Keywords
- OSA, Mandibular Advancement Splint, Oral Appliance, Treatment, Orthodontic Implants
- 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.
Implant Supported Mandibular Advancement Oral ApplianceDevice
This device is a novel oral appliance that attached to orthodontic mini implants in the jaw and is designed to keep the jaw in an advanced position, opening the upper airway during sleep.
Orthodontic Mini ImplantDevice
Also called Temporary Anchorage Devices (TADs)
Small titanium devices that are fixed to the bone for the purpose of enhancing anchorage of other orthodontic devices.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | Participants will be treated with a novel experimental implant supported mandibular advancement oral appliance, which uniquely attaches to orthodontic mini implants (OMIs) in the jaw. Participants will be fitted with OMIs per standard clinical practice prior to treatment with the novel oral appliance. Receives: Device: Implant Supported Mandibular Advancement Oral Appliance; Device: Orthodontic Mini Implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Apnea-Hypopnea Index (AHI)
Indication of the severity of sleep apnea. The AHI is calculated by dividing the number of apnea events by the number of hours of sleep. This outcome will assess the change in AHI over time.
Measured: Data collected at 0, and 1 months after initiation of treatment with the new appliance.
Secondary outcomes (10)
Daytime Sleepiness
Evaluation of OSA specific fatigue using Epworth Sleepiness Scale (ESS) questionnaire. ESS measures daytime sleepiness via 8 questions that ask about daytime sleepiness during common everyday conditions. The potential range of scores for any questions is from 0 to 3. Higher values represent worse outcomes. Their are no subscales for ESS. The answers to the questions are all summed up. Total score ranges between 0 and 24. A score above 10 indicates daytime sleepiness with higher scores indicating more sleepiness.
Measured: Data collected at 0, 1, and 4 months after initiation of treatment with the new appliance.
Arterial Oxygen Saturation
Using a pulse oximeter to determine the percentage of hemoglobin binding sites in the bloodstream occupied by oxygen.
Measured: Data collected at 0, 1, and 4 months after initiation of treatment with the new appliance.
Treatment Adherence
Self-reported use of the appliance by recording the number of hours per night and the number of nights per week that the appliance is used.
Measured: Data will be collected by the research team 4 months after initiation of treatment with the new appliance.
Patient Experience
Subjective patient experience data collected from semi-structured interviews.
Measured: Data collected 1 and 4 months after initiation of treatment with the new appliance.
Mini Implant Side Effects - Mobility
Using tactile assessment to determine implant mobility per Ngiam et al. Mobility will be graded from 0-2 depending on severity. 0 represents no mobility whereas 2 represents mobility greater than 1mm. There is an additional option for total mobility or implant loss.
Measured: Data collected at 1 week, 1 month and 4 months after initiation of treatment with the new appliance.
Mini Implant Side Effects - Gingival Irritation
Gingival irritation will be determined using tactile/visual assessment. Irritation will be scored as either YES (present) or NO (absent).
Measured: Data collected at 1 week, 1 month and 4 months after initiation of treatment with the new appliance.
Mini Implant Side Effects - Soreness
Soreness will be determined using tactile/visual assessment and self-reported by patients. Soreness will be scored as either YES (present) or NO (absent).
Measured: Data collected at 1 week, 1 month and 4 months after initiation of treatment with the new appliance.
Mini Implant Side Effects - Jaw Pain
Jaw pain will be determined using tactile/visual assessment and self-reported by patients. Jaw pain will be scored as either YES (present) or NO (absent).
Measured: Data collected at 1 week, 1 month and 4 months after initiation of treatment with the new appliance.
Mini Implant Side Effects - Excess Salivation
Excess salivation will be determined using visual assessment and self-reported by patients. Excess salivation will be scored as either YES (present) or NO (absent).
Measured: Data collected at 1 week, 1 month and 4 months after initiation of treatment with the new appliance.
Mini Implant Side Effects - Other
A brief description of any other side effects will be self-reported by patients.
Measured: Data collected at 1 week, 1 month and 4 months after initiation of treatment with the new appliance.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2017
- Study start1 Apr 2018
- Primary completion11 Jun 2019
- Study completion11 Sep 2019
Why it stopped: the initial design of the novel oral appliance proved uncomfortable and thus terminated trial after three subjects.
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 University of British ColumbiaThe 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Benjamin Pliska, University of British Columbia
- Investigators
- Benjamin T Pliska, DDS, Principal investigator, University British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03362671
- Sponsor's protocol ID
- 14G31862
- Acronym
- BIMA
- Status last verified
- Nov 2022
- First submitted
- 23 Nov 2017
- Last updated
- 22 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bimaxillary Implant Supported Mandibular Advancement Pilot
- ClinicalTrials.gov ID
- NCT03362671
- Acronym / sponsor ID
- BIMA / 14G31862
- Conditions
- Obstructive Sleep Apnea
- Keywords
- OSA, Mandibular Advancement Splint, Oral Appliance, Treatment, Orthodontic Implants
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: the initial design of the novel oral appliance proved uncomfortable and thus terminated trial after three subjects.
- Enrolment
- 3 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 11 Jun 2019 (actual)
- Study completion
- 11 Sep 2019 (actual)
- First posted
- 5 Dec 2017 (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.
Mandibular advancing oral appliances (OAm) are an effective and increasingly common treatment modality for the management of obstructive sleep apnea (OSA) in adults.
The effectiveness of OAm therapy, however, is dependent on a high level of patient adherence, which may be negatively impacted by treatment side effects - the most significant of which are occlusal changes and tooth movement.
The proposed pilot study will evaluate the efficacy of a novel implant supported OAm in 10 OSA patients who have already been successfully treated with a traditional OAm.
The study will compare OSA specific outcomes with traditional OAm use against novel oral appliance use after one month. This study could potentially validate the novel design features of an effective treatment option for OSA that does not result in tooth movement, which is a significant side effect shared by all existing OAm devices.
Ultimately, this study could lead to increased treatment adherence and better OSA patient health outcomes in the future.
Detailed description
Mandibular advancement oral appliances (OAm) are devices that keep the airway open during sleep by pulling the lower jaw forward. OAm have been shown to be an effective treatment for both mild and severe OSA. OSA is a chronic disease and there is no cure. OSA treatments depend on high patient adherence for long term effectiveness.
Currently marketed OAm devices attach to the teeth as a way of holding the jaw in position. However, attaching directly to the teeth causes unwanted tooth movement with long term OAm use. As a result, some long-term users of OAm have stopped treatment due to a decrease in quality of life caused by tooth movement. Accordingly, the changes in tooth position can be seen as a limitation of the existing appliances. For this reason, there is a strong need for a type of treatment that can effectively pull the jaw forward without causing movement of the teeth, which is inevitable with the way the current OAm devices work.
This trial is a pilot study to find out if a novel OAm device is an effective treatment for OSA. The novel OAm device does not contact the teeth directly but instead attaches to orthodontic mini implants (OMIs) in the jaw. 10 OSA patients who have previously been successfully treated with a traditional OAm appliance will be fitted with the novel oral appliance. Participants will be fitted with 6 OMIs following standard practice and the bespoke oral appliance will be manufactured and delivered to the patient for use.
Prior to receiving treatment, participants will undergo a baseline assessment where demographic, anthropometric, and specific periodontal health data will be collected. Daytime sleepiness will be assessed and at-home sleep test will be used to establish baseline sleep parameters with the existing appliance.
Follow up sleep tests will be completed 1 month after initiation of treatment with the new appliance. ESS questionnaires and treatment experience interviews will be completed at 1 month and 4 months after the start of treatment with the new appliance. Treatment adherence and OMI side effects will be monitored throughout the study. Patients will be given the option of continuing treatment with the novel device or having the implants removed and returning to treatment with their previous OAm.
To directly address the primary aim of this study, OSA related parameters will be measured by a combination of methods including at-home sleep tests and Epworth Sleepiness Scale (ESS) questionnaires. Secondary outcome variables to assess treatment adherence and satisfaction include self-reported adherence data using sleep diaries, experience interviews and assessing OMI side effects throughout the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Device: Implant Supported Mandibular Advancement Oral Appliance, Device: Orthodontic Mini ImplantParticipants will be treated with a novel experimental implant supported mandibular advancement oral appliance, which uniquely attaches to orthodontic mini implants (OMIs) in the jaw. Participants will be fitted with OMIs per standard clinical practice prior to treatment with the novel oral appliance. |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- This trial will recruit 10 patients with an objective diagnosis of obstructive sleep apnea who are not naïve to treatment. The inclusion criteria are:
- Currently receive or have previously received successful OSA treatment with an OAm;
- Age 25 - 65 years old, who are able to freely provide informed consent;
- Body Mass Index (BMI) ≤ 35;
- Apnea-Hypopnea Index (AHI) within the range 5≤AHI≤50 documented with polysomnography in the last 2 years *OR*
Key exclusion criteria (16 listed)
- Extensive periodontal disease;
- Bleeding disorder;
- Bone metabolic disorder
- Immunocompromised
- Diabetes mellitus
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 |
|---|---|---|
| Implant Supported Mandibular Advancement Oral ApplianceThis device is a novel oral appliance that attached to orthodontic mini implants in the jaw and is designed to keep the jaw in an advanced position, opening the upper airway during sleep. | Device | Treatment Group |
| Orthodontic Mini ImplantAlso: Temporary Anchorage Devices (TADs)Small titanium devices that are fixed to the bone for the purpose of enhancing anchorage of other orthodontic devices. | Device | Treatment Group |
Primary outcome
Change in Apnea-Hypopnea Index (AHI)
Time frame: Data collected at 0, and 1 months after initiation of treatment with the new appliance.
Indication of the severity of sleep apnea. The AHI is calculated by dividing the number of apnea events by the number of hours of sleep. This outcome will assess the change in AHI over time.
10 secondary outcomes
Daytime Sleepiness
Time frame: Data collected at 0, 1, and 4 months after initiation of treatment with the new appliance.
Arterial Oxygen Saturation
Time frame: Data collected at 0, 1, and 4 months after initiation of treatment with the new appliance.
Treatment Adherence
Time frame: Data will be collected by the research team 4 months after initiation of treatment with the new appliance.
Patient Experience
Time frame: Data collected 1 and 4 months after initiation of treatment with the new appliance.
Mini Implant Side Effects - Mobility
Time frame: Data collected at 1 week, 1 month and 4 months after initiation of treatment with the new appliance.
Mini Implant Side Effects - Gingival Irritation
Time frame: Data collected at 1 week, 1 month and 4 months after initiation of treatment with the new appliance.
Mini Implant Side Effects - Soreness
Time frame: Data collected at 1 week, 1 month and 4 months after initiation of treatment with the new appliance.
Mini Implant Side Effects - Jaw Pain
Time frame: Data collected at 1 week, 1 month and 4 months after initiation of treatment with the new appliance.
Mini Implant Side Effects - Excess Salivation
Time frame: Data collected at 1 week, 1 month and 4 months after initiation of treatment with the new appliance.
Mini Implant Side Effects - Other
Time frame: Data collected at 1 week, 1 month and 4 months after initiation of treatment with the new appliance.
Results and safety
The study was stopped early (reason given: the initial design of the novel oral appliance proved uncomfortable and thus terminated trial after three subjects.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2022.
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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.
Benjamin T Pliska, DDS principal investigator
University British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Implant Supported Mandibular Advancement Oral Appliance and Orthodontic Mini Implant in people with Obstructive Sleep Apnea, run by University of British Columbia 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 7 inclusion and 16 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: stopped early, as of the sponsor's last update on 22 Nov 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 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 was stopped early (reason given: the initial design of the novel oral appliance proved uncomfortable and thus terminated trial after three subjects.). Results are not available in the source record.
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?
Change in Apnea-Hypopnea Index (AHI) (time frame: Data collected at 0, and 1 months after initiation of treatment with the new appliance.). 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 22 Nov 2022.