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Long Term Oral Appliance Therapy Effectiveness for Obstructive Sleep Apnea Syndrome

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ClinicalTrials.gov Identifier: NCT02410850
Recruitment Status : Not yet recruiting
First Posted : April 8, 2015
Last Update Posted : June 14, 2017
Sponsor:
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
Information provided by (Responsible Party):
Fernanda Almeida, University of British Columbia

Brief 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. 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.

Condition or disease Intervention/treatment
Obstructive Sleep Apnea Device: Oral Appliance

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 Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Long Term Oral Appliance Therapy Effectiveness for Obstructive Sleep Apnea: A Multicenter Cohort Study
Estimated Study Start Date : August 1, 2017
Estimated Primary Completion Date : September 2022
Estimated Study Completion Date : September 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

Group/Cohort Intervention/treatment
University of Montreal
Patients from University of Montreal in Canada
Device: Oral Appliance
Mandibular Advancement Splints

University of Antwerp
Patients from University of Antwerp in Belgium.
Device: Oral Appliance
Mandibular Advancement Splints

University of Sydney
Patients from University of Sydney in Australia.
Device: Oral Appliance
Mandibular Advancement Splints

Angers University Hospital
Patients from Angers University Hospital in France.
Device: Oral Appliance
Mandibular Advancement Splints

University of Gronigen
Patients from University of Gronigen in Netherlands.
Device: Oral Appliance
Mandibular Advancement Splints

Kaiser Permanente
Patients from Kaiser Permanente from USA.
Device: Oral Appliance
Mandibular Advancement Splints

Stanford University
Patients from Stanford University from USA.
Device: Oral Appliance
Mandibular Advancement Splints

Laval University
Patients from Laval University in Canada.
Device: Oral Appliance
Mandibular Advancement Splints

Cambridge University
Patients from Cambridge University in UK.
Device: Oral Appliance
Mandibular Advancement Splints

Kyushu University
Patients from Kyushu University in Japan
Device: Oral Appliance
Mandibular Advancement Splints

Japan Somnology Center
Patients from Japan Somnology Center in Japan.
Device: Oral Appliance
Mandibular Advancement Splints

Uniformed Services University
Patients from the Uniformed Services University in USA.
Device: Oral Appliance
Mandibular Advancement Splints

University of British Columbia
Patients from the University of British Columbia in Canada.
Device: Oral Appliance
Mandibular Advancement Splints




Primary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]

Secondary Outcome Measures :
  1. Objective adherence by assessing Oral Appliance adherence chip data [ Time Frame: 1,3,5 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who seek Oral Appliance therapy.
Criteria

Inclusion Criteria:

  • Patients are currently prescribed Oral Appliance for their Obstructive Sleep Apnea

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02410850


Contacts
Contact: Fernanda Almeida, DDS,PhD 604-822-3623 falmeida@dentistry.ubc.ca
Contact: Sundus Hussain 604-827-0690 sundush@dentistry.ubc.ca

Sponsors and Collaborators
University of British Columbia
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
Investigators
Principal Investigator: Fernanda Almeida, DDS,Phd University of British Columbia

Responsible Party: Fernanda Almeida, Principle Investigator, University of British Columbia
ClinicalTrials.gov Identifier: NCT02410850     History of Changes
Other Study ID Numbers: H14-00743
First Posted: April 8, 2015    Key Record Dates
Last Update Posted: June 14, 2017
Last Verified: June 2017

Keywords provided by Fernanda Almeida, University of British Columbia:
Oral Appliance
objective adherence
cardiovascular events
cardiovascular mortality
cerebrovascular mortality
cost effectiveness

Additional relevant MeSH terms:
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Apnea
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases