Obstructive Sleep ApneaNCT02410850
Long Term Oral Appliance Therapy Effectiveness for Obstructive Sleep Apnea Syndrome
An observational study of Obstructive Sleep Apnea, run by University of British Columbia at 1 site in Canada.
Trial summary
Obstructive sleep apnea (OSA) is a highly prevalent breathing problem that occurs during sleep. OSA have been associated with the obesity epidemic in developing countries; additionally, high OSA prevalence rates are present in populations with cardiovascular and metabolic disorders. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- Oral Appliance
- Type of treatment
- Pill or oral medicine, Medical device
- How many people
- 1,000 participants
- Where
- 1 siteCanada
- Study dates
- 1 Apr 2018to Sep 2026
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who seek Oral Appliance therapy.
Who may be able to join
- Patients are currently prescribed Oral Appliance for their Obstructive Sleep Apnea
Who cannot join
- Patients under the age of 18 years.
- Patients that do not understand the English language.
- Patients that refuse to sign the informed consent for any reason.
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
University of British Columbia
Vancouver, British Columbia, V6T 1Z3
Fernanda R Almeida, PhD, 6048223623, falmeida@dentistry.ubc.ca
Mary Wong, mwong@dentistry.ubc.ca
About this study
Official title: Long Term Oral Appliance Therapy Effectiveness for Obstructive Sleep Apnea: A Multicenter Cohort Study
Obstructive sleep apnea (OSA) is a highly prevalent breathing problem that occurs during sleep. OSA have been associated with the obesity epidemic in developing countries; additionally, high OSA prevalence rates are present in populations with cardiovascular and metabolic disorders. Two OSA treatments are currently available, oral appliance (OA) therapy and continuous positive airway pressure (CPAP). OAs are an underutilized non-surgical treatment and few studies have analyzed their long-term effectiveness for patients with OSA. The purpose of this study is to assess the long-term effectiveness of OA therapy in patients with OSA and to explore any changes on cardiovascular related morbidity and mortality related to this therapy.
Read the detailed description
Obstructive sleep apnea (OSA) is a chronic condition which may occur when an individual is sleeping. OSA incidence rates ranges from 4 to 16% of the adult population. The prevalence of OSA is even higher in populations with cardiovascular and metabolic disorders (e.g. stroke or diabetes mellitus).
OSA is characterized by five or more pauses in breathing per hour or partial obstruction of airway during sleep.
Obstructive sleep apnea (OSA) is currently being treated using two methods: oral appliance (OA) therapy and continuous positive airway pressure (CPAP). Although the American Academy of Sleep Medicine (AASM) has approved both methods as a first line treatment for mild and moderate OSA, oral appliances have been underutilized despite their non-invasive, quietness, the fact they are non-surgical and, cost effectiveness. OAs can also be an alternative for severe OSA patients who find CPAP treatment intolerable. There are two major groups of OAs available, one that acts on repositioning the mandible and tongue; this includes mandibular advancement splints (MAS) and Mandibular advancement devices (MAD). The other group of OAs, tongue retaining devices (TRD) focus on holding the tongue forward. It is because of the positioning of the tongue and mandible that OAs is effective in decreasing sleep apnea. OA therapy is a long-term treatment and therefore it is important that the appliance be comfortable to encourage patient use.
Despite the benefits to patients using OAs, previous studies have not looked at the relationship between OAs and OSA in long term studies or in a large number of patients. This lack of research and knowledge has led to an absence in training and education for dentists who are able to provide OA therapy to their patients. OAs have been shown to not be as effective as CPAP in helping with OSA, however, it has similar effects on blood pressure, quality of life, sleepiness and endothelial function. Previous studies have shown that the effects of OA therapy on patients' OSA are associated with more acceptance and adherence. Previous longitudinal studies that followed patients using CPAP showed great benefits in terms of cardiovascular health. It is therefore necessary for large sample size, long term prospective cohort studies to be done to determine how effective OA therapy is for patients with OSA, while also looking at potential effects on cardiovascular morbidity and mortality. It is for this reason that 15 centres from 9 counties around the world have formed a network called ORANGE (Oral Appliance Network on Global Effectiveness) dedicated on the long-term outcomes of OAs.
These centers included: University of Sidney (Australia), Stanford University (USA). Kaiser Permanente (USA), Cambridge University (UK), Paris Hospital (France), University of Antwerp (Belgium), Japan Somnology Center (Japan), Kyushu University (Japan), University of British Columbia (Canada), University of Montreal (Canada), Laval University (Canada), University of Gronigen (Netherlands), and Umea University (Sweden).
- Conditions
- Obstructive Sleep Apnea
- Being tested
- Oral Appliance
- Keywords
- Oral Appliance, objective adherence, cardiovascular events, cardiovascular mortality, cerebrovascular mortality, cost effectiveness
- 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.
Oral ApplianceDevice
Mandibular Advancement Splints
| Study group | Role | What they receive |
|---|---|---|
| University of Montreal | Patients from University of Montreal in Canada Receives: Device: Oral Appliance | |
| University of Antwerp | Patients from University of Antwerp in Belgium. Receives: Device: Oral Appliance | |
| University of Sydney | Patients from University of Sydney in Australia. Receives: Device: Oral Appliance | |
| Angers University Hospital | Patients from Angers University Hospital in France. Receives: Device: Oral Appliance | |
| University of Gronigen | Patients from University of Gronigen in Netherlands. Receives: Device: Oral Appliance | |
| Kaiser Permanente | Patients from Kaiser Permanente from USA. Receives: Device: Oral Appliance | |
| Stanford University | Patients from Stanford University from USA. Receives: Device: Oral Appliance | |
| Laval University | Patients from Laval University in Canada. Receives: Device: Oral Appliance | |
| Cambridge University | Patients from Cambridge University in UK. Receives: Device: Oral Appliance | |
| Kyushu University | Patients from Kyushu University in Japan Receives: Device: Oral Appliance | |
| Japan Somnology Center | Patients from Japan Somnology Center in Japan. Receives: Device: Oral Appliance | |
| Uniformed Services University | Patients from the Uniformed Services University in USA. Receives: Device: Oral Appliance | |
| University of British Columbia | Patients from the University of British Columbia in Canada. Receives: Device: Oral Appliance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Long term effectiveness of Oral Appliance therapy by assessing responses to treatment specific questionnaires and other questionnaires such as Functional Outcomes of Sleep Questionnaire (FOSQ), Epworth Sleepiness Scale(ESS), and Short Form 36 (SF-36)
Measured: 5 years
Impact of Oral Appliance therapy on cardiovascular morbidity by assessing health changes, hospitalizations and number of deaths during treatment with Oral Appliance
Measured: 5 years
Impact of Oral Appliance therapy on cardiovascular mortality by assessing health changes, hospitalizations and number of deaths during treatment with Oral Appliance
Measured: 5 years
Secondary outcomes (1)
Objective adherence by assessing Oral Appliance adherence chip data
Measured: 1,3,5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2015 (estimated)
- Study start1 Apr 2018
- Primary completionSep 2026 (estimated)
- Study completionSep 2026 (estimated)
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Universiteit Antwerpen, University of Sydney, University Hospital, Angers, University of Groningen, Université de Montréal, Kaiser Permanente, Stanford University, Laval University, University of Cambridge, Kyushu University, Japan Somnology Center, Neuropsychiatric Research Institute, Uniformed Services University of the Health Sciences
- Responsible party
- Principal investigator, Fernanda Almeida, University of British Columbia
- Investigators
- Fernanda Almeida, DDS,Phd, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02410850
- Sponsor's protocol ID
- H14-00743
- Status last verified
- Jan 2024
- First submitted
- 30 Mar 2015
- Last updated
- 23 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long Term Oral Appliance Therapy Effectiveness for Obstructive Sleep Apnea: A Multicenter Cohort Study
- ClinicalTrials.gov ID
- NCT02410850
- Acronym / sponsor ID
- H14-00743
- Conditions
- Obstructive Sleep Apnea
- Keywords
- Oral Appliance, objective adherence, cardiovascular events, cardiovascular mortality, cerebrovascular mortality, cost effectiveness
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- Universiteit Antwerpen, University of Sydney, University Hospital, Angers, University of Groningen, Université de Montréal, Kaiser Permanente, Stanford University, Laval University, University of Cambridge, Kyushu University, Japan Somnology Center, Neuropsychiatric Research Institute, Uniformed Services University of the Health Sciences
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 8 Apr 2015 (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.
Obstructive sleep apnea (OSA) is a highly prevalent breathing problem that occurs during sleep. OSA have been associated with the obesity epidemic in developing countries; additionally, high OSA prevalence rates are present in populations with cardiovascular and metabolic disorders. Two OSA treatments are currently available, oral appliance (OA) therapy and continuous positive airway pressure (CPAP). OAs are an underutilized non-surgical treatment and few studies have analyzed their long-term effectiveness for patients with OSA. The purpose of this study is to assess the long-term effectiveness of OA therapy in patients with OSA and to explore any changes on cardiovascular related morbidity and mortality related to this therapy.
Detailed description
Obstructive sleep apnea (OSA) is a chronic condition which may occur when an individual is sleeping. OSA incidence rates ranges from 4 to 16% of the adult population. The prevalence of OSA is even higher in populations with cardiovascular and metabolic disorders (e.g. stroke or diabetes mellitus).
OSA is characterized by five or more pauses in breathing per hour or partial obstruction of airway during sleep.
Obstructive sleep apnea (OSA) is currently being treated using two methods: oral appliance (OA) therapy and continuous positive airway pressure (CPAP). Although the American Academy of Sleep Medicine (AASM) has approved both methods as a first line treatment for mild and moderate OSA, oral appliances have been underutilized despite their non-invasive, quietness, the fact they are non-surgical and, cost effectiveness. OAs can also be an alternative for severe OSA patients who find CPAP treatment intolerable. There are two major groups of OAs available, one that acts on repositioning the mandible and tongue; this includes mandibular advancement splints (MAS) and Mandibular advancement devices (MAD). The other group of OAs, tongue retaining devices (TRD) focus on holding the tongue forward. It is because of the positioning of the tongue and mandible that OAs is effective in decreasing sleep apnea. OA therapy is a long-term treatment and therefore it is important that the appliance be comfortable to encourage patient use.
Despite the benefits to patients using OAs, previous studies have not looked at the relationship between OAs and OSA in long term studies or in a large number of patients. This lack of research and knowledge has led to an absence in training and education for dentists who are able to provide OA therapy to their patients. OAs have been shown to not be as effective as CPAP in helping with OSA, however, it has similar effects on blood pressure, quality of life, sleepiness and endothelial function. Previous studies have shown that the effects of OA therapy on patients' OSA are associated with more acceptance and adherence. Previous longitudinal studies that followed patients using CPAP showed great benefits in terms of cardiovascular health. It is therefore necessary for large sample size, long term prospective cohort studies to be done to determine how effective OA therapy is for patients with OSA, while also looking at potential effects on cardiovascular morbidity and mortality. It is for this reason that 15 centres from 9 counties around the world have formed a network called ORANGE (Oral Appliance Network on Global Effectiveness) dedicated on the long-term outcomes of OAs.
These centers included: University of Sidney (Australia), Stanford University (USA). Kaiser Permanente (USA), Cambridge University (UK), Paris Hospital (France), University of Antwerp (Belgium), Japan Somnology Center (Japan), Kyushu University (Japan), University of British Columbia (Canada), University of Montreal (Canada), Laval University (Canada), University of Gronigen (Netherlands), and Umea University (Sweden).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 13
| Arm | Type | Receives |
|---|---|---|
| University of Montreal | – | Device: Oral AppliancePatients from University of Montreal in Canada |
| University of Antwerp | – | Device: Oral AppliancePatients from University of Antwerp in Belgium. |
| University of Sydney | – | Device: Oral AppliancePatients from University of Sydney in Australia. |
| Angers University Hospital | – | Device: Oral AppliancePatients from Angers University Hospital in France. |
| University of Gronigen | – | Device: Oral AppliancePatients from University of Gronigen in Netherlands. |
| Kaiser Permanente | – | Device: Oral AppliancePatients from Kaiser Permanente from USA. |
| Stanford University | – | Device: Oral AppliancePatients from Stanford University from USA. |
| Laval University | – | Device: Oral AppliancePatients from Laval University in Canada. |
| Cambridge University | – | Device: Oral AppliancePatients from Cambridge University in UK. |
| Kyushu University | – | Device: Oral AppliancePatients from Kyushu University in Japan |
| Japan Somnology Center | – | Device: Oral AppliancePatients from Japan Somnology Center in Japan. |
| Uniformed Services University | – | Device: Oral AppliancePatients from the Uniformed Services University in USA. |
| University of British Columbia | – | Device: Oral AppliancePatients from the University of British Columbia in Canada. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who seek Oral Appliance therapy.
Key inclusion criteria (1 listed)
- Patients are currently prescribed Oral Appliance for their Obstructive Sleep Apnea
Key exclusion criteria (3 listed)
- Patients under the age of 18 years.
- Patients that do not understand the English language.
- Patients that refuse to sign the informed consent for any reason.
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 |
|---|---|---|
| Oral ApplianceMandibular Advancement Splints | Device | Angers University Hospital, Cambridge University, Japan Somnology Center, Kaiser Permanente, Kyushu University, Laval University, Stanford University, Uniformed Services University, University of Antwerp, University of British Columbia, University of Gronigen, University of Montreal, University of Sydney |
Primary outcome
Long term effectiveness of Oral Appliance therapy by assessing responses to treatment specific questionnaires and other questionnaires such as Functional Outcomes of Sleep Questionnaire (FOSQ), Epworth Sleepiness Scale(ESS), and Short Form 36 (SF-36)
Time frame: 5 years
Impact of Oral Appliance therapy on cardiovascular morbidity by assessing health changes, hospitalizations and number of deaths during treatment with Oral Appliance
Time frame: 5 years
Impact of Oral Appliance therapy on cardiovascular mortality by assessing health changes, hospitalizations and number of deaths during treatment with Oral Appliance
Time frame: 5 years
1 secondary outcome
Objective adherence by assessing Oral Appliance adherence chip data
Time frame: 1,3,5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2024.
Related trials for Obstructive Sleep Apnea
Not yet recruitingObservational study
Orthognathic Surgery and Obstructive Sleep Apnea Assessed by Mandibular Jaw Movement Monitoring (SUNRISE-ORTHO)
Obstructive Sleep Apnea, Sleep Apnea, Obstructive
Not yet recruitingObservational study
Association Between Metabolic Associated Fatty Liver Disease and Obstructive Sleep Apnea
Obstructive Sleep Apnea, Metabolic Dysfunction-Associated Steatotic Liver Disease
Not yet recruitingPhase 2/3
Tirzepatide Versus Positive Airway Pressure for the Treatment of Obstructive Sleep Apnoea
Sleep Apnoea, Obesity & Overweight
RecruitingObservational study
Development and Clinical Validation of Artificial Intelligence Algorithms for Sleep Staging and Obstructive Sleep Apnea Screening Based on a Large-Scale Model Trained on Multimodal Physiological Signals From Diverse Populations
Sleep Apnea, Obstructive, Sleep Staging
Not yet recruitingPhase 2
Oxytocin for Respiratory Compromise and Hypoventilation Induced by Drugs
Obesity & Overweight, Respiratory Depression
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.
Fernanda Almeida, DDS,Phd principal investigator
University of British Columbia
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 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 1 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 23 Jan 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fernanda Almeida, DDS,PhD (604-822-3623, falmeida@dentistry.ubc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Long term effectiveness of Oral Appliance therapy by assessing responses to treatment specific questionnaires and other questionnaires such as Functional Outcomes of Sleep Questionnaire (FOSQ), Epworth Sleepiness Scale(ESS), and Short Form 36 (SF-36) (time frame: 5 years). 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 23 Jan 2024.