AzTrials
AzTrials

Obstructive Sleep ApneaCHOICENCT02242617

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

A study testing Positive Airway Pressure (PAP) and Mandibular Advancement Splints (MAS) in people with Obstructive Sleep Apnea, run by University of British Columbia at 3 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 19 to 75 years
Conditions the study is for
Obstructive Sleep Apnea
What is being tested?
Positive Airway Pressure (PAP) and Mandibular Advancement Splints (MAS)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
79 participants
Where
3 sitesCanada
Study dates
Nov 2015to Jun 2020
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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
Show all 10Show fewer
  • 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.

Who cannot join

  • 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;
Show all 13Show fewer
  • 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.

Trial locations and contacts

3 sites in 1 country.

Canada3 sites

  • University of Montreal / Université de Montréal

    Montreal, Quebec, H3T 1J4

  • Laval University / Université Laval

    Québec, G1V 4G5

  • University of British Columbia

    Vancouver, British Columbia, V6T 1Z3

Other trials in Canada

About this study

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.

Read the 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.

Being tested
Positive Airway Pressure (PAP), Mandibular Advancement Splints (MAS)
Keywords
Adherence, CPAP, Oral Appliance, Mandibular Advancement Splints, Preference
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.

  • Positive Airway Pressure (PAP)Device

    Also called CPAP, auto-CPAP, APAP

    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)Device

    Also called Oral appliance, Mandibular advancement devices, Somnodent device

    Mandibular advancement splints (MAS): dental splints used to keep the mandible in an advanced position opening the upper airway during sleep

Study groups in NCT02242617
Study groupRoleWhat they receive
MAS-PAPActive comparatorMandibular 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)
Receives: Device: Positive Airway Pressure (PAP); Device: Mandibular Advancement Splints (MAS)
PAP-MASActive comparatorPositive 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)
Receives: Device: Positive Airway Pressure (PAP); Device: Mandibular Advancement Splints (MAS)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: At 1 month in the MAS treatment arm

  2. 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.

    Measured: At 1 month in CPAP treatment arm

  3. 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.

    Measured: At 1 month of using both treatments interchangeably.

  4. 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.

    Measured: At 6 months of using both treatments interchangeably

Secondary outcomes (23)

  1. Apnea-hypopnea index

    Measuring apnea-hypopnea index (events/hour of sleep from Stardust-Phillips Respironics) to measure intervention efficacy (e.g. AHI)

    Measured: At baseline

  2. Functional Outcomes of Sleep Questionnaire (FOSQ) responses

    Measuring Functional Outcomes of Sleep Questionnaire (FOSQ) responses to evaluate disease specific quality of life.

    Measured: At baseline

  3. Epworth Sleepiness Scale (ESS) questionnaire responses.

    Measuring responses to Epworth Sleepiness Scale (ESS) Questionnaire to compare daytime sleepiness.

    Measured: At baseline

  4. Chalder fatigue scale questionnaire responses

    Measuring responses to the Chalder fatigue scale which assesses fatigue in the present state.

    Measured: At baseline

  5. SF-36 survey responses

    Measuring SF-36 survey responses which assesses general health status.

    Measured: At baseline

  6. Apnea-hypopnea index

    Measuring changes in apnea-hypopnea index (events/hour of sleep from Stardust-Phillips Respironics) to measure intervention efficacy (e.g. AHI)

    Measured: At 1 month in MAS treatment arm

  7. Apnea-hypopnea index

    Measuring changes in apnea-hypopnea index (events/hour of sleep from Stardust-Phillips Respironics) to measure intervention efficacy (e.g. AHI)

    Measured: At 1 month in CPAP treatment arm

  8. Functional Outcomes of Sleep Questionnaire (FOSQ) responses.

    Measuring changes in Functional Outcomes of Sleep Questionnaire (FOSQ) responses to evaluate disease specific quality of life.

    Measured: At 1 month in MAS treatment arm

  9. Functional Outcomes of Sleep Questionnaire (FOSQ) responses.

    Measuring changes in Functional Outcomes of Sleep Questionnaire (FOSQ) responses to evaluate disease specific quality of life.

    Measured: At 1 month of using both treatments interchangeably

  10. Functional Outcomes of Sleep Questionnaire (FOSQ) responses

    Measuring changes in Functional Outcomes of Sleep Questionnaire (FOSQ) responses to evaluate disease specific quality of life.

    Measured: At 6 months of using both treatments interchangeably

  11. Functional Outcomes of Sleep Questionnaire (FOSQ) responses.

    Measuring changes in Functional Outcomes of Sleep Questionnaire (FOSQ) responses to evaluate disease specific quality of life.

    Measured: At 1 month in CPAP treatment arm

  12. Epworth Sleepiness Scale (ESS) questionnaire responses.

    Measuring changes in Epworth Sleepiness Scale (ESS) Questionnaire responses to compare daytime sleepiness.

    Measured: At 1 month in MAS treatment arm

  13. Epworth Sleepiness Scale (ESS) questionnaire responses.

    Measuring changes in responses to Epworth Sleepiness Scale (ESS) Questionnaire to compare daytime sleepiness

    Measured: At 1 month in CPAP treatment arm.

  14. Epworth Sleepiness Scale (ESS) questionnaire responses

    Measuring changes in responses to Epworth Sleepiness Scale (ESS) Questionnaire to compare daytime sleepiness.

    Measured: At 1 month of using both treatments interchangeably

  15. Epworth Sleepiness Scale (ESS) questionnaire responses.

    Measuring changes in responses to Epworth Sleepiness Scale (ESS) Questionnaire to compare daytime sleepiness.

    Measured: At 6 months of using both treatments interchangeably.

  16. Chalder fatigue scale questionnaire responses

    Measuring changes in responses to the Chalder fatigue scale which assesses fatigue in the present state.

    Measured: At 1 month in MAS treatment arm

  17. Chalder fatigue scale questionnaire responses

    Measuring changes in responses to the Chalder fatigue scale which assesses fatigue in the present state.

    Measured: At 1 month in CPAP treatment arm

  18. Chalder fatigue scale questionnaire responses

    Measuring changes in responses to the Chalder fatigue scale which assesses fatigue in the present state.

    Measured: At 1 month of using both treatments interchangeably

  19. Chalder fatigue scale questionnaire responses

    Measuring changes in responses to the Chalder fatigue scale which assesses fatigue in the present state.

    Measured: At 6 months of using both treatments interchangeably.

  20. SF-36 survey responses.

    Measuring changes in SF-36 survey responses which assesses general health status.

    Measured: At 1 month in MAS treatment arm

  21. SF-36 survey responses.

    Measuring changes in SF-36 survey responses which assesses general health status.

    Measured: At 1 month in CPAP treatment arm.

  22. SF-36 survey responses.

    Measuring changes in SF-36 survey responses which assesses general health status.

    Measured: At 1 month of using both treatments interchangeably.

  23. SF-36 survey responses.

    Measuring changes in SF-36 survey responses which assesses general health status.

    Measured: At 6 months of using both treatments interchangeably.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Sep 2014 (estimated)
  2. Study startNov 2015
  3. Primary completionJun 2020
  4. Study completionJun 2020

Resources

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
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
79 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02242617
Sponsor's protocol ID
H14-01215
Other IDs
RN325361
Acronym
CHOICE
Status last verified
Nov 2022
First submitted
29 Aug 2014
Last updated
30 Nov 2022
Results posted
No
Data monitoring committee
Yes

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.

    PubMed 23585745

  • 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.

    PubMed 33745505

Questions about this trial

What is this clinical trial studying?

A study testing Positive Airway Pressure (PAP) and Mandibular Advancement Splints (MAS) in people with Obstructive Sleep Apnea, run by University of British Columbia at 3 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 10 inclusion and 13 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: finished, as of the sponsor's last update on 30 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Objectively measured adherence (hours/night and nights/week of intervention use). (time frame: At 1 month in the MAS treatment arm). 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?

On the ClinicalTrials.gov record for NCT02242617, which also lists 2 linked publications.

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 30 Nov 2022.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in