Dual Obstructive Sleep Apnea Therapy (DOT)
Primary Purpose
Obstructive Sleep Apnea
Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Dual Therapy
Sponsored by
About this trial
This is an interventional supportive care trial for Obstructive Sleep Apnea focused on measuring OSA, Continous Positive Airway Pressure (CPAP), Mandibular Advancement Split (MAS), Mandibular Advancement Oral Appliance, Dual Therapy
Eligibility Criteria
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.
Sites / Locations
- University of British Columbia
- Université de Montréal
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment Group
Arm Description
This group will undergo 1 month Dual Therapy.
Outcomes
Primary Outcome Measures
Change in CPAP Pressure
Optimal CPAP Pressure determined by the Respiratory Therapist (cmH2O)
Comfort
A subjective assessment of the Dual Therapy treatment, reported via a questionnaire.
Treatment Adherence (hrs/night)
Adherence measured in hours per night.
Treatment Adherence (% nights)
Adherence measured in percentage of nights of use.
Secondary Outcome Measures
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.
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.
Efficacy - Oxygen Desaturation Index
The number of times per hour of sleep that the blood's oxygen level drop below 97% oxygen saturation.
Efficacy - Time below 90% Saturation
Percentage of time during sleep that the patient's blood oxygen levels fall below 90% saturation.
Efficacy - Minimum Saturation
The lowest percentage saturation of the patient's blood oxygen levels during sleep.
Full Information
NCT ID
NCT03435731
First Posted
February 8, 2018
Last Updated
April 30, 2018
Sponsor
University of British Columbia
Collaborators
Université de Montréal
1. Study Identification
Unique Protocol Identification Number
NCT03435731
Brief Title
Dual Obstructive Sleep Apnea Therapy
Acronym
DOT
Official Title
Dual Obstructive Sleep Apnea (OSA) Therapy (MAS With PAP)
Study Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Unknown status
Study Start Date
March 8, 2018 (Actual)
Primary Completion Date
October 2018 (Anticipated)
Study Completion Date
December 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of British Columbia
Collaborators
Université de Montréal
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea
Keywords
OSA, Continous Positive Airway Pressure (CPAP), Mandibular Advancement Split (MAS), Mandibular Advancement Oral Appliance, Dual Therapy
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treatment Group
Arm Type
Experimental
Arm Description
This group will undergo 1 month Dual Therapy.
Intervention Type
Combination Product
Intervention Name(s)
Dual Therapy
Intervention Description
Concomitant use of Continuous Positive Airway Pressure (CPAP) and Mandibular Advancement Splint (MAS) therapeutic devices.
Primary Outcome Measure Information:
Title
Change in CPAP Pressure
Description
Optimal CPAP Pressure determined by the Respiratory Therapist (cmH2O)
Time Frame
Baseline (from previous treatment with CPAP) and 1 month after commencing Dual Therapy treatment.
Title
Comfort
Description
A subjective assessment of the Dual Therapy treatment, reported via a questionnaire.
Time Frame
Baseline (from previous treatment) and 1 month after commencing Dual Therapy treatment.
Title
Treatment Adherence (hrs/night)
Description
Adherence measured in hours per night.
Time Frame
The duration of Dual Therapy treatment (1 month).
Title
Treatment Adherence (% nights)
Description
Adherence measured in percentage of nights of use.
Time Frame
The duration of Dual Therapy treatment (1 month).
Secondary Outcome Measure Information:
Title
Daytime Sleepiness
Description
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.
Time Frame
Baseline (from previous treatment) and 1 month after commencing Dual Therapy treatment.
Title
Quality of Life using Functional Outcomes of Sleep Questionnaire (FOSQ-10)
Description
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.
Time Frame
Baseline (from previous treatment) and 1 month after commencing Dual Therapy treatment.
Title
Efficacy - Oxygen Desaturation Index
Description
The number of times per hour of sleep that the blood's oxygen level drop below 97% oxygen saturation.
Time Frame
Baseline (from previous treatment) and 1 month after commencing Dual Therapy treatment.
Title
Efficacy - Time below 90% Saturation
Description
Percentage of time during sleep that the patient's blood oxygen levels fall below 90% saturation.
Time Frame
Baseline (from previous treatment) and 1 month after commencing Dual Therapy treatment.
Title
Efficacy - Minimum Saturation
Description
The lowest percentage saturation of the patient's blood oxygen levels during sleep.
Time Frame
Baseline (from previous treatment) and 1 month after commencing Dual Therapy treatment.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
University of British Columbia
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6T 1Z3
Country
Canada
Facility Name
Université de Montréal
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H3T 1J4
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Dual Obstructive Sleep Apnea Therapy
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