Adherence and Preference of Continuous Positive Airway Pressure Versus Mandibular Advancement Splints in Obstructive Sleep Apnea Patients: A Randomized Trial
Condition: Obstructive Sleep Apnea
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Positive Airway Pressure (PAP); Mandibular Advancement Splints (MAS)
Intervention type(s): Device; Device
Intervention description(s): 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; Mandibular advancement splints (MAS): dental splints used to keep the mandible in an advanced position opening the upper airway during sleep
Other intervention name(s): CPAP, auto-CPAP, APAP; Oral appliance; Mandibular advancement devices; Somnodent device
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Adherence; CPAP; Oral Appliance; Mandibular Advancement Splints; Preference