Dual Obstructive Sleep Apnea Therapy (DOT)

Dual Obstructive Sleep Apnea (OSA) Therapy (MAS With PAP)

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.

Study Overview

• Status: Unknown
• Conditions: Obstructive Sleep Apnea
• Intervention / Treatment: Combination product: Dual Therapy

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V6T 1Z3
      • University of British Columbia
  • Quebec
    • Montréal, Quebec, Canada, h3t 1j4
      • Université de Montréal

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age 19-80 years old who are able to freely provide informed consent;
• Prior participation in the CHOICE study;
• Have been optimally titrated to PAP and MAS therapy;
• Have both PAP and MAS appliances at home and ready for use;
• Body mass index (BMI) of 35 or less;
• ≥ 8 teeth per arch to support treatment with MAS;
• Have an objective of diagnosis of OSA based on the following criteria:
• - an Apnea-Hypopnea Index (AHI) within the range 10 ≤ AHI ≤ 70 documented with polysomnography in the last 2 years; ***OR***
• - a Respiratory Disturbance Index (RDI) within the range 20 ≤ RDI ≤ 70 documented with level III portable sleep test; ***OR***
• - an Oxygen Desaturation Index (ODI) ≥ 10;
• Sleep investigations confirming the object diagnosis of OSA have been performed within the past 4 years

Exclusion Criteria:

• Use of a full face mask as the PAP interface;
• Extensive periodontal disease with significant tooth mobility;
• Inability to protrude jaw;
• Insufficient vertical opening to accommodate treatment with MAS;
• Uncontrolled congestive heart failure (defined as a prior clinical diagnosis, an ejection cut-off of 40% or clinical sign in the opinion of a primary care physician or cardiologist) that makes it unsafe in the opinion of the investigators for the subject to participate in the trial;
• Coronary artery disease unless stable for at least 6 months and considered by the investigators to have a stable disease;
• Any history of angina, myocardial infarction or stroke;
• Any history of major depressive disorder along with current moderate-severe disease;
• Active cancer management (unless in remission for more than 1 year);
• Known renal failure (with need for dialysis);
• History of a near miss or prior automobile accident due to sleepiness within the past 12 months;
• At nighttime, 30% of the night is at ≤ 90% oxygen saturation levels.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Treatment Group; This group will undergo 1 month Dual Therapy.	Combination product: Dual Therapy; Concomitant use of Continuous Positive Airway Pressure (CPAP) and Mandibular Advancement Splint (MAS) therapeutic devices.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in CPAP Pressure	Optimal CPAP Pressure determined by the Respiratory Therapist (cmH2O)	Baseline (from previous treatment with CPAP) and 1 month after commencing Dual Therapy treatment.
Comfort	A subjective assessment of the Dual Therapy treatment, reported via a questionnaire.	Baseline (from previous treatment) and 1 month after commencing Dual Therapy treatment.
Treatment Adherence (hrs/night)	Adherence measured in hours per night.	The duration of Dual Therapy treatment (1 month).
Treatment Adherence (% nights)	Adherence measured in percentage of nights of use.	The duration of Dual Therapy treatment (1 month).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Daytime Sleepiness	Evaluation of OSA specific fatigue using Epworth Sleepiness Scale (ESS) questionnaire. ESS measures daytime sleepiness via 8 questions that ask about daytime sleepiness during common everyday conditions. The potential range of scores for any questions is from 0 to 3. Higher values represent worse outcomes. Their are no subscales for ESS. The answers to the questions are all summed up. Total score ranges between 0 and 24. A score above 10 indicates daytime sleepiness with higher scores indicating more sleepiness.	Baseline (from previous treatment) and 1 month after commencing Dual Therapy treatment.
Quality of Life using Functional Outcomes of Sleep Questionnaire (FOSQ-10)	FOSQ-10 measures functional status and difficulty in performing everyday activities via 10 questions. The range of scores for any question is from 1 to 4. There is also a 0 score option for participants who do not engage in a particular activity for other reasons, in which case the question will be excluded. There are 5 subscales that measure: general productivity, activity level, vigilance, social outcomes, and intimacy and sexual relationships. To obtain the total score, a mean-weighted item score is computed for those subscales with more than one item. To calculate a mean-weighted item score calculate the mean of the answered items with responses > 1 for each subscale. The total score is then derived by calculating the mean of the subscale scores and multiplying that mean by five. Total score ranges between 5 and 20. Higher scores indicate better functional status.	Baseline (from previous treatment) and 1 month after commencing Dual Therapy treatment.
Efficacy - Oxygen Desaturation Index	The number of times per hour of sleep that the blood's oxygen level drop below 97% oxygen saturation.	Baseline (from previous treatment) and 1 month after commencing Dual Therapy treatment.
Efficacy - Time below 90% Saturation	Percentage of time during sleep that the patient's blood oxygen levels fall below 90% saturation.	Baseline (from previous treatment) and 1 month after commencing Dual Therapy treatment.
Efficacy - Minimum Saturation	The lowest percentage saturation of the patient's blood oxygen levels during sleep.	Baseline (from previous treatment) and 1 month after commencing Dual Therapy treatment.

Collaborators and Investigators

• Sponsor: University of British Columbia
• Collaborators: Université de Montréal

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 8, 2018
• Primary Completion (ANTICIPATED): October 1, 2018
• Study Completion (ANTICIPATED): December 1, 2018

Study Registration Dates

• First Submitted: February 8, 2018
• First Submitted That Met QC Criteria: February 14, 2018
• First Posted (ACTUAL): February 19, 2018

Study Record Updates

• Last Update Posted (ACTUAL): May 2, 2018
• Last Update Submitted That Met QC Criteria: April 30, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: OSA; Dual Therapy; Continous Positive Airway Pressure (CPAP); Mandibular Advancement Split (MAS); Mandibular Advancement Oral Appliance
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Apnea
• Other Study ID Numbers: H18-00175; FCRC1801 (OTHER: Frontier Clinical Research Centre)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No