An interventional study of Positive Airway Pressure (PAP) and Mandibular Advancement Splints (MAS) in Obstructive Sleep Apnea, sponsored by University of British Columbia. Completed at 3 sites in Canada. Open to participants aged 19 Years to 75 Years. Per ClinicalTrials.gov, last updated 2022-11-30.
Sponsored by University of British Columbia · Not applicable, Interventional, and Treatment
Obstructive sleep apnea (OSA) is a major health problem affecting over 1,000,000 Canadians. It is the cause of significant healthcare costs with increased morbidity and mortality. The two most common and effective therapies used to treat OSA are: (1) Continuous or Automatic Positive Airway Pressure (PAP), and (2) Mandibular Advancement Splints (MAS). While both therapies reduce upper airway collapse during sleep, they differ in efficacy, acceptance, cost and side-effects, but surprisingly are similar in improving quality of life, sleepiness and blood pressure. PAP is more effective in reducing apneas while MAS is easier to use. Until now, studies have used self-reported adherence data on MAS versus objective adherence on PAP. Many studies have hypothesized that the sub-optimal efficacy with MAS therapy is counterbalanced by the superior adherence relative to PAP, resulting in a similar effectiveness for both treatments. Compliance smart chips are a recent innovation for MAS and could be used to prove this hypothesis and allow a new and complete comparison of effectiveness (efficacy + adherence) between MAS and PAP. Understanding the patient's objective adherence and long-term symptomatic improvement would provide vital information to doctors and dentists in choosing the right treatment for patients. Sixty OSA patients will receive both PAP and MAS in a random sequence. This innovative study lead by two experienced new investigators, and a research team of multidisciplinary experts, will assess objective adherence, treatment efficacy, patient preference, sleepiness and quality of life of each treatment used at home for 1 month per treatment. After this, patients will be able to go back and forth between both treatments during an additional 6-month period. The results of this study will be used by healthcare policy makers as well as clinicians who need to be part of the treatment plan decision for the many Canadians who suffer from sleep apnea.
The primary aim of this study is to assess objective adherence to treatment, for PAP and MAS, and to evaluate if there will be similar effectiveness (efficacy+adherence) between PAP and MAS treatment for patients with mild to severe OSA. The secondary aim is to assess if patient preference does correlate to the final treatment adherence. An exploratory aim is to assess if the strategy of patients having both treatments available to use interchangeably could further improve treatment adherence, sleepiness, quality of life and fatigue. Having a better insight into patient adherence will improve the cost-effectiveness of treatment and will improve the health and quality of life for many Canadians who suffer from sleep apnea.
The proposed trial is a randomized open-label, two-treatment, two-period cross-over trial followed by an observational trial. Sixty OSA patients (10≤AHI≤50) will receive both PAP and MAS. As a recent innovation, we have adherence monitors for MAS that can give a new and comprehensive comparative analysis of the effectiveness between MAS and PAP. In the randomized trial phase the two treatments will be used separately for 1 month each (after treatment adaptation/titration of 1-2 months for each device). Treatment efficacy and daily treatment use data will be assessed together with changes in symptoms (quality of life, sleepiness and fatigue). Patient initial preference will be determined by using a patient decision aid. This will be followed by the observational trial phase, where all patients will have access to both interventions at home for 6 months and be allowed to choose on a daily basis the intervention to use. The intervention duration of 6 months is to allow for a sustained response in long-term adherence and to observe changes in quality of life.
1,422 studies on the registry are indexed under Apnea; 159 are open to participants now.
This study's enrollment of 79 is above the median of 50 across 965 interventional studies indexed under Apnea.
Browse Apnea studies →University of British Columbia is the lead sponsor of 1,309 studies on the registry; 253 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 1 (17%) have results posted.
Counted across the registry records on this site, refreshed daily.
You may be able to participate in this study if:
You have:
Exclusion Criteria:
You may not be able to participate in this study if:
Mandibular advancement splints (MAS): dental splints used to keep the mandible in an advanced position opening the upper airway during sleep; followed by positive airway pressure (PAP)
Device: Positive Airway Pressure (PAP) · Device: Mandibular Advancement Splints (MAS)
Positive airway pressure (PAP): a device which consists of a face mask attached to a plastic tube and a machine that blows compressed air through a patient's airway during sleep to keep the airway open; followed by mandibular advancement splints (MAS)
Device: Positive Airway Pressure (PAP) · Device: Mandibular Advancement Splints (MAS)
Continuous or auto-adjusting positive airway pressure (i.e. CPAP, APAP, and described here as PAP): a device which consists of a face mask attached to a plastic tube and a machine that blows compressed air through a patient's airway during sleep to keep the airway open
Also known as: CPAP, auto-CPAP, APAP
Mandibular advancement splints (MAS): dental splints used to keep the mandible in an advanced position opening the upper airway during sleep
Also known as: Oral appliance, Mandibular advancement devices, Somnodent device
Objectively measured adherence (hours/night and nights/week of intervention use).
Measuring objective adherence (hours/night and nights/week of intervention use), indicated by the smart chips and symptoms.
Time frame: At 1 month in the MAS treatment arm
Objectively measured adherence (hours/night and nights/week of intervention use).
Measuring changes in objectively measured adherence (hours/night and nights/week of intervention use), indicated by the smart chips and symptoms.
Time frame: At 1 month in CPAP treatment arm
Objectively measured adherence (hours/night and nights/week of intervention use).
Measuring changes in objectively measured adherence (hours/night and nights/week of intervention use), indicated by the smart chips and symptoms.
Time frame: At 1 month of using both treatments interchangeably.
Objectively measured adherence (hours/night and nights/week of intervention use).
Measuring changes in objectively measured adherence (hours/night and nights/week of intervention use), indicated by the smart chips and symptoms.
Time frame: At 6 months of using both treatments interchangeably
Apnea-hypopnea index
Measuring apnea-hypopnea index (events/hour of sleep from Stardust-Phillips Respironics) to measure intervention efficacy (e.g. AHI)
Time frame: At baseline
Functional Outcomes of Sleep Questionnaire (FOSQ) responses
Measuring Functional Outcomes of Sleep Questionnaire (FOSQ) responses to evaluate disease specific quality of life.
Time frame: At baseline
Epworth Sleepiness Scale (ESS) questionnaire responses.
Measuring responses to Epworth Sleepiness Scale (ESS) Questionnaire to compare daytime sleepiness.
Time frame: At baseline
Chalder fatigue scale questionnaire responses
Measuring responses to the Chalder fatigue scale which assesses fatigue in the present state.
Time frame: At baseline
SF-36 survey responses
Measuring SF-36 survey responses which assesses general health status.
Time frame: At baseline
Apnea-hypopnea index
Measuring changes in apnea-hypopnea index (events/hour of sleep from Stardust-Phillips Respironics) to measure intervention efficacy (e.g. AHI)
Time frame: At 1 month in MAS treatment arm
Apnea-hypopnea index
Measuring changes in apnea-hypopnea index (events/hour of sleep from Stardust-Phillips Respironics) to measure intervention efficacy (e.g. AHI)
Time frame: At 1 month in CPAP treatment arm
Functional Outcomes of Sleep Questionnaire (FOSQ) responses.
Measuring changes in Functional Outcomes of Sleep Questionnaire (FOSQ) responses to evaluate disease specific quality of life.
Time frame: At 1 month in MAS treatment arm
Functional Outcomes of Sleep Questionnaire (FOSQ) responses.
Measuring changes in Functional Outcomes of Sleep Questionnaire (FOSQ) responses to evaluate disease specific quality of life.
Time frame: At 1 month of using both treatments interchangeably
Functional Outcomes of Sleep Questionnaire (FOSQ) responses
Measuring changes in Functional Outcomes of Sleep Questionnaire (FOSQ) responses to evaluate disease specific quality of life.
Time frame: At 6 months of using both treatments interchangeably
Functional Outcomes of Sleep Questionnaire (FOSQ) responses.
Measuring changes in Functional Outcomes of Sleep Questionnaire (FOSQ) responses to evaluate disease specific quality of life.
Time frame: At 1 month in CPAP treatment arm
Epworth Sleepiness Scale (ESS) questionnaire responses.
Measuring changes in Epworth Sleepiness Scale (ESS) Questionnaire responses to compare daytime sleepiness.
Time frame: At 1 month in MAS treatment arm
Epworth Sleepiness Scale (ESS) questionnaire responses.
Measuring changes in responses to Epworth Sleepiness Scale (ESS) Questionnaire to compare daytime sleepiness
Time frame: At 1 month in CPAP treatment arm.
Epworth Sleepiness Scale (ESS) questionnaire responses
Measuring changes in responses to Epworth Sleepiness Scale (ESS) Questionnaire to compare daytime sleepiness.
Time frame: At 1 month of using both treatments interchangeably
Epworth Sleepiness Scale (ESS) questionnaire responses.
Measuring changes in responses to Epworth Sleepiness Scale (ESS) Questionnaire to compare daytime sleepiness.
Time frame: At 6 months of using both treatments interchangeably.
Chalder fatigue scale questionnaire responses
Measuring changes in responses to the Chalder fatigue scale which assesses fatigue in the present state.
Time frame: At 1 month in MAS treatment arm
Chalder fatigue scale questionnaire responses
Measuring changes in responses to the Chalder fatigue scale which assesses fatigue in the present state.
Time frame: At 1 month in CPAP treatment arm
Chalder fatigue scale questionnaire responses
Measuring changes in responses to the Chalder fatigue scale which assesses fatigue in the present state.
Time frame: At 1 month of using both treatments interchangeably
Chalder fatigue scale questionnaire responses
Measuring changes in responses to the Chalder fatigue scale which assesses fatigue in the present state.
Time frame: At 6 months of using both treatments interchangeably.
SF-36 survey responses.
Measuring changes in SF-36 survey responses which assesses general health status.
Time frame: At 1 month in MAS treatment arm
SF-36 survey responses.
Measuring changes in SF-36 survey responses which assesses general health status.
Time frame: At 1 month in CPAP treatment arm.
SF-36 survey responses.
Measuring changes in SF-36 survey responses which assesses general health status.
Time frame: At 1 month of using both treatments interchangeably.
SF-36 survey responses.
Measuring changes in SF-36 survey responses which assesses general health status.
Time frame: At 6 months of using both treatments interchangeably.
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University of British Columbia