Adherence and Preference of Continuous Positive Airway Pressure Versus Mandibular Advancement Splints in Obstructive Sleep Apnea Patients: A Randomized Trial (CHOICE)

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.

Study Overview

• Status: Completed
• Conditions: Obstructive Sleep Apnea
• Intervention / Treatment: Device: Positive Airway Pressure (PAP); Device: Mandibular Advancement Splints (MAS)

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.

• Study Type: Interventional
• Enrollment (Actual): 79
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Québec, Canada, G1V 4G5
    • Laval University / Université Laval
  • British Columbia
    • Vancouver, British Columbia, Canada, V6T 1Z3
      • University of British Columbia
  • Quebec
    • Montréal, Quebec, Canada, H3T 1J4
      • University of Montreal / Université de Montréal

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

You may be able to participate in this study if:

• You are naïve to treatment (never used CPAP or oral appliance, nor had surgery for sleep apnea);
• You are between 19-75 years old;
• You have a Body Mass Index (BMI) ≤ 35;
• You have enough teeth (at least 8 per arch) for MAS;

• You have:

  • an Apnea-Hypopnea Index (AHI) within the range 10 ≤ AHI ≤ 50 documented with polysomnography in the last 2 years; ***OR***
  • a Respiratory Disturbance Index (RDI) within the range 20 ≤ RDI ≤ 50 documented with level III portable sleep test; ***OR***
  • an Oxygen Desaturation Index (ODI) ≥ 10; and
• You have had a sleep test within the past 2 years.

Exclusion Criteria:

You may not be able to participate in this study if:

• You have extensive periodontal disease with significant tooth mobility (disease around your teeth);
• You are unable to protrude the jaw (unable to extend your jaw);
• You have a lack of a sufficient vertical opening to accommodate an appliance;
• You have uncontrolled congestive heart failure (defined as a prior clinical diagnosis, an ejection cutoff of 40% or a clinical sign in the opinion of a primary care physician or cardiologist) that makes it unsafe for you to participate in the trial in the opinion of the investigators;
• You have coronary artery disease unless stable for at least 6 months and considered by the investigators to have a stable disease;
• You have a history of angina (chest pain when your heart does not get enough blood), myocardial infarction (heart attack) or stroke;
• You have a history of major depressive disorder (such as bipolar disorder) along with current moderate or severe disease;
• You have cancer unless in remission (decreasing signs of your cancer being present) for more than 1 year;
• You have known renal (kidney) failure with need for dialysis;
• You are pregnant (if a female participant becomes pregnant during the trial, she will be withdrawn from the study);
• You have had a near miss or prior automobile accident due to sleepiness within the past 12 months; and/or
• At nighttime, 30% of the night is at ≤ 90% oxygen saturation levels.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: MAS-PAP; 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); 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; Other Names: CPAP, auto-CPAP, APAP; Device: Mandibular Advancement Splints (MAS); Mandibular advancement splints (MAS): dental splints used to keep the mandible in an advanced position opening the upper airway during sleep; Other Names: Oral appliance; Mandibular advancement devices; Somnodent device
Active Comparator: PAP-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); 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; Other Names: CPAP, auto-CPAP, APAP; Device: Mandibular Advancement Splints (MAS); Mandibular advancement splints (MAS): dental splints used to keep the mandible in an advanced position opening the upper airway during sleep; Other Names: Oral appliance; Mandibular advancement devices; Somnodent device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	At 6 months of using both treatments interchangeably

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Apnea-hypopnea index	Measuring apnea-hypopnea index (events/hour of sleep from Stardust-Phillips Respironics) to measure intervention efficacy (e.g. AHI)	At baseline
Functional Outcomes of Sleep Questionnaire (FOSQ) responses	Measuring Functional Outcomes of Sleep Questionnaire (FOSQ) responses to evaluate disease specific quality of life.	At baseline
Epworth Sleepiness Scale (ESS) questionnaire responses.	Measuring responses to Epworth Sleepiness Scale (ESS) Questionnaire to compare daytime sleepiness.	At baseline
Chalder fatigue scale questionnaire responses	Measuring responses to the Chalder fatigue scale which assesses fatigue in the present state.	At baseline
SF-36 survey responses	Measuring SF-36 survey responses which assesses general health status.	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)	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)	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.	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.	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.	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.	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.	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	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.	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.	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.	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.	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.	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.	At 6 months of using both treatments interchangeably.
SF-36 survey responses.	Measuring changes in SF-36 survey responses which assesses general health status.	At 1 month in MAS treatment arm
SF-36 survey responses.	Measuring changes in SF-36 survey responses which assesses general health status.	At 1 month in CPAP treatment arm.
SF-36 survey responses.	Measuring changes in SF-36 survey responses which assesses general health status.	At 1 month of using both treatments interchangeably.
SF-36 survey responses.	Measuring changes in SF-36 survey responses which assesses general health status.	At 6 months of using both treatments interchangeably.

Collaborators and Investigators

• Sponsor: University of British Columbia
• Collaborators: Laval University; Université de Montréal
• Investigators: Principal Investigator: Fernanda R Almeida, DDS, MSc, PhD, University of British Columbia

Publications and helpful links

General Publications

• Almeida FR, Mulgrew A, Ayas N, Tsuda H, Lowe AA, Fox N, Harrison S, Fleetham JA. Mandibular advancement splint as short-term alternative treatment in patients with obstructive sleep apnea already effectively treated with continuous positive airway pressure. J Clin Sleep Med. 2013 Apr 15;9(4):319-24. doi: 10.5664/jcsm.2576.
• Alshhrani WM, Hamoda MM, Okuno K, Kohzuka Y, Fleetham JA, Ayas NT, Comey R, Almeida FR. The efficacy of a titrated tongue-stabilizing device on obstructive sleep apnea: a quasi-experimental study. J Clin Sleep Med. 2021 Aug 1;17(8):1607-1618. doi: 10.5664/jcsm.9260.

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2015
• Primary Completion (Actual): June 1, 2020
• Study Completion (Actual): June 1, 2020

Study Registration Dates

• First Submitted: August 29, 2014
• First Submitted That Met QC Criteria: September 15, 2014
• First Posted (Estimate): September 17, 2014

Study Record Updates

• Last Update Posted (Actual): November 30, 2022
• Last Update Submitted That Met QC Criteria: November 24, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: Adherence; CPAP; Oral Appliance; Preference; Mandibular Advancement Splints
• 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: H14-01215; RN325361 (Other Grant/Funding Number: Canadian Institute of Health Research (CIHR))