Dual Obstructive Sleep Apnea Therapy — DOT  

Obstructive Sleep Apnea Clinical Trial

Official title: Dual Obstructive Sleep Apnea (OSA) Therapy (MAS With PAP)

Status Enrolling by invitation

Clinical Trial Summary

Continuous positive airway pressure (CPAP) is considered the gold standard therapy for obstructive sleep apnea (OSA). However, CPAP users sometimes experience pressure-related discomfort. It is thought that lower CPAP pressure may increase comfort and lead to greater treatment adherence.

Mandibular advancement splint (MAS) therapy has been shown to be the preferred OSA treatment option among patients. However, MAS therapy is only partially effective in some OSA patients, especially in severe cases.

It is thought that a combination of MAS and PAP therapy may benefit patients in which MAS alone is only partially effective. Using MAS and PAP at the same time is called "Dual Therapy". Dual Therapy may allow a lower CPAP pressure to be applied, which may increase patient comfort and therefore increase treatment adherence and overall effectiveness.

This study will evaluate the effectiveness of 1 month of Dual Therapy in 30 OSA patients.

Clinical Trial Description

This is a prospective clinical trial assessing the effect of 1-month of dual therapy on patients with varying baseline OSA severity (mild to severe) who have been previously fully titrated to both PAP and MAS.

This study will be conducted at 2 research centers; the Faculty of Dentistry, University of British Columbia (UBC), Vancouver and at the Faculty of Dentistry, Université de Montréal (UdM), Montréal.

The research team will access participants' records to confirm eligibility for dual therapy. The clinical research coordinator will contact eligible patients via phone to ask if they are interested in taking part in the study. Eligible patients will also be asked if they are interested in taking part in the study during routine clinic visits. Where possible, patients will not be approached by their primary caregiver regarding participation in this study, to ensure patients do not feel pressurized into participating. Choosing not to take part in the study will not affect the participants' quality of care. If a patient is interested in taking part in the study they will be invited to review and sign the informed consent form.

Consenting participants will be asked to use both MAS and PAP (dual therapy) together for a period of 1 month. During the first week of the dual therapy, PAP pressure will be adjusted automatically for a 1-week period, after which the pressure will be set remotely by the Respiratory Therapist at the 90th percentile.

With permission, the research team will access the Sleep Apnea Dental Clinic records to collect data relating to previous treatment with MAS and PAP monotherapies. Data collected includes: PAP pressure, treatment adherence, subjective treatment assessment, Epworth Sleepiness Scale (ESS) and Functional Outcomes of Sleep Questionnaires (FOSQ), weight, blood pressure and oximetry data.

At the end of the 1-month, a subjective and objective assessment will be conducted. Subjective data will be collected using a short questionnaire that will be completed by the participants pertaining to their experience with the dual therapy in addition to completing a short term medical/treatment update form. Participants' weight and blood pressure will also be reassessed. Objective adherence will be analyzed via data obtained from the PAP modem and from DentiTrac® smart chips embedded in the MAS. OSA-related quality of life will be reassessed using ESS and FOSQ questionnaires. ;

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

• NCT number: NCT03435731
• Study type: Interventional
• Source: University of British Columbia
• Status: Enrolling by invitation
• Phase: N/A
• Start date: March 8, 2018
• Completion date: December 2018