Obstructive Sleep ApneaDOTNCT03435731
Dual Obstructive Sleep Apnea Therapy
A study testing Dual Therapy in people with Obstructive Sleep Apnea, run by University of British Columbia at 2 sites in Canada.
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. Read more about this study
- Who is it for?
- Ages 19 to 80 years
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- Dual Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesCanada
- Study dates
- 8 Mar 2018to Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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
Who cannot join
- 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;
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- 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.
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Université de Montréal
Montreal, Quebec, H3T 1J4
University of British Columbia
Vancouver, British Columbia, V6T 1Z3
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- Dual Therapy
- Keywords
- OSA, Continous Positive Airway Pressure (CPAP), Mandibular Advancement Split (MAS), Mandibular Advancement Oral Appliance, Dual Therapy
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dual TherapyCombination product
Concomitant use of Continuous Positive Airway Pressure (CPAP) and Mandibular Advancement Splint (MAS) therapeutic devices.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | This group will undergo 1 month Dual Therapy. Receives: Combination Product: Dual Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in CPAP Pressure
Optimal CPAP Pressure determined by the Respiratory Therapist (cmH2O)
Measured: 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.
Measured: Baseline (from previous treatment) and 1 month after commencing Dual Therapy treatment.
Treatment Adherence (hrs/night)
Adherence measured in hours per night.
Measured: The duration of Dual Therapy treatment (1 month).
Treatment Adherence (% nights)
Adherence measured in percentage of nights of use.
Measured: The duration of Dual Therapy treatment (1 month).
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline (from previous treatment) and 1 month after commencing Dual Therapy treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2018
- Study start8 Mar 2018
- Primary completionOct 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Université de Montréal
- Responsible party
- Principal investigator, Fernanda Almeida, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03435731
- Sponsor's protocol ID
- H18-00175
- Other IDs
- FCRC1801
- Acronym
- DOT
- Status last verified
- Apr 2018
- First submitted
- 8 Feb 2018
- Last updated
- 2 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dual Obstructive Sleep Apnea (OSA) Therapy (MAS With PAP)
- ClinicalTrials.gov ID
- NCT03435731
- Acronym / sponsor ID
- DOT / H18-00175
- Conditions
- Obstructive Sleep Apnea
- Keywords
- OSA, Continous Positive Airway Pressure (CPAP), Mandibular Advancement Split (MAS), Mandibular Advancement Oral Appliance, Dual Therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- Université de Montréal
- Study start
- 8 Mar 2018 (actual)
- Primary completion
- Oct 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 19 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Combination Product: Dual TherapyThis group will undergo 1 month Dual Therapy. |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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;
Key exclusion criteria (12 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dual TherapyConcomitant use of Continuous Positive Airway Pressure (CPAP) and Mandibular Advancement Splint (MAS) therapeutic devices. | Combination product | Treatment Group |
Primary outcome
Change in CPAP Pressure
Time frame: Baseline (from previous treatment with CPAP) and 1 month after commencing Dual Therapy treatment.
Optimal CPAP Pressure determined by the Respiratory Therapist (cmH2O)
Comfort
Time frame: Baseline (from previous treatment) and 1 month after commencing Dual Therapy treatment.
A subjective assessment of the Dual Therapy treatment, reported via a questionnaire.
Treatment Adherence (hrs/night)
Time frame: The duration of Dual Therapy treatment (1 month).
Adherence measured in hours per night.
Treatment Adherence (% nights)
Time frame: The duration of Dual Therapy treatment (1 month).
Adherence measured in percentage of nights of use.
5 secondary outcomes
Daytime Sleepiness
Time frame: Baseline (from previous treatment) and 1 month after commencing Dual Therapy treatment.
Quality of Life using Functional Outcomes of Sleep Questionnaire (FOSQ-10)
Time frame: Baseline (from previous treatment) and 1 month after commencing Dual Therapy treatment.
Efficacy - Oxygen Desaturation Index
Time frame: Baseline (from previous treatment) and 1 month after commencing Dual Therapy treatment.
Efficacy - Time below 90% Saturation
Time frame: Baseline (from previous treatment) and 1 month after commencing Dual Therapy treatment.
Efficacy - Minimum Saturation
Time frame: Baseline (from previous treatment) and 1 month after commencing Dual Therapy treatment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dual Therapy in people with Obstructive Sleep Apnea, run by University of British Columbia at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in CPAP Pressure (time frame: Baseline (from previous treatment with CPAP) and 1 month after commencing Dual Therapy treatment.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2018; AzTrials last refreshed its copy on 4 Nov 2026.