Recruiting

Oral Appliance Therapy

Sponsor:

University of British Columbia

Code:

NCT02410850

Conditions

Obstructive Sleep Apnea

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Oral Appliance

Study Details

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

Study ID

NCT02410850

Start date

Apr 1, 2018

Status verified date

Jan, 2024

Completion date

Sep, 2026

Anticipated

Primary completion date

Sep, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

1000 participants

Anticipated

Interventions and Outcome Measures

Arms

University of Montreal

Patients from University of Montreal in Canada

University of Antwerp

Patients from University of Antwerp in Belgium.

University of Sydney

Patients from University of Sydney in Australia.

Angers University Hospital

Patients from Angers University Hospital in France.

University of Gronigen

Patients from University of Gronigen in Netherlands.

Kaiser Permanente

Patients from Kaiser Permanente from USA.

Stanford University

Patients from Stanford University from USA.

Laval University

Patients from Laval University in Canada.

Cambridge University

Patients from Cambridge University in UK.

Kyushu University

Patients from Kyushu University in Japan

Japan Somnology Center

Patients from Japan Somnology Center in Japan.

Uniformed Services University

Patients from the Uniformed Services University in USA.

University of British Columbia

Patients from the University of British Columbia in Canada.

Interventions

Oral Appliance

Mandibular Advancement Splints

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 ]
  • 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 ]

Central Contacts and Locations

Central contacts

Fernanda Almeida, DDS,PhD

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

Mary Wong

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

Locations

University of British Columbia

Recruiting

Vancouver, British Columbia, Canada, V6T 1Z3

Contacts

Fernanda R Almeida, PhD

6048223623falmeida@dentistry.ubc.ca

Mary Wong

mwong@dentistry.ubc.ca

More Information

Sponsor

University of British Columbia

Last update posted

Jan 23, 2024

Last verified

Jan, 2024

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of British Columbia on 2024-01-23.