Long Term Oral Appliance Therapy Effectiveness for Obstructive Sleep Apnea Syndrome

NCT02410850 | Recruiting

• 1 other identifier: H14-00743
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Obstructive Sleep Apnea

Keywords

Oral Appliance; objective adherence; cardiovascular events; cardiovascular mortality; cerebrovascular mortality; cost effectiveness

Outcome Measures

Primary Outcomes (3)

• 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)

  5 years

• Impact of Oral Appliance therapy on cardiovascular morbidity by assessing health changes, hospitalizations and number of deaths during treatment with Oral Appliance

  5 years

• Impact of Oral Appliance therapy on cardiovascular mortality by assessing health changes, hospitalizations and number of deaths during treatment with Oral Appliance

  5 years

Secondary Outcomes (1)

• Objective adherence by assessing Oral Appliance adherence chip data

  1,3,5 years

Study Arms (13)

University of Montreal

Patients from University of Montreal in Canada

Device: Oral Appliance

University of Antwerp

Patients from University of Antwerp in Belgium.

Device: Oral Appliance

University of Sydney

Patients from University of Sydney in Australia.

Device: Oral Appliance

Angers University Hospital

Patients from Angers University Hospital in France.

Device: Oral Appliance

University of Gronigen

Patients from University of Gronigen in Netherlands.

Device: Oral Appliance

Kaiser Permanente

Patients from Kaiser Permanente from USA.

Device: Oral Appliance

Stanford University

Patients from Stanford University from USA.

Device: Oral Appliance

Laval University

Patients from Laval University in Canada.

Device: Oral Appliance

Cambridge University

Patients from Cambridge University in UK.

Device: Oral Appliance

Kyushu University

Patients from Kyushu University in Japan

Device: Oral Appliance

Japan Somnology Center

Patients from Japan Somnology Center in Japan.

Device: Oral Appliance

Uniformed Services University

Patients from the Uniformed Services University in USA.

Device: Oral Appliance

University of British Columbia

Patients from the University of British Columbia in Canada.

Device: Oral Appliance

Interventions

Oral Appliance DEVICE

Mandibular Advancement Splints

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

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who seek Oral Appliance therapy.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

University of British Columbia

Vancouver, British Columbia, V6T 1Z3, Canada

RECRUITING

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Fernanda Almeida, DDS,Phd

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fernanda Almeida, DDS,PhD

CONTACT

604-822-3623; falmeida@dentistry.ubc.ca

Mary Wong

CONTACT

604-827-0690; mwong@dentistry.ubc.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: March 30, 2015
• First Posted: April 8, 2015
• Study Start: April 1, 2018
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: January 23, 2024

Record last verified: 2024-01

Locations

CA (1)