Long Term Oral Appliance Therapy Effectiveness for Obstructive Sleep Apnea Syndrome

January 21, 2024 updated by: Fernanda Almeida, University of British Columbia

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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

Enrollment (Estimated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 86 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients who seek Oral Appliance therapy.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
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
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
5 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Objective adherence by assessing Oral Appliance adherence chip data
Time Frame: 1,3,5 years
1,3,5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of British Columbia

Collaborators

University Hospital, Angers
Stanford University
Kaiser Permanente
University of Sydney
University of Cambridge
Laval University
Uniformed Services University of the Health Sciences
Universiteit Antwerpen
Université de Montréal
University of Groningen
Kyushu University
Japan Somnology Center, Neuropsychiatric Research Institute

Investigators

  • Principal Investigator: Fernanda Almeida, DDS,Phd, University of British Columbia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2018

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

September 1, 2026

Study Registration Dates

First Submitted

March 30, 2015

First Submitted That Met QC Criteria

April 7, 2015

First Posted (Estimated)

April 8, 2015

Study Record Updates

Last Update Posted (Actual)

January 23, 2024

Last Update Submitted That Met QC Criteria

January 21, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H14-00743

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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