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

NCT02242617 | Completed DMC

• 2 other identifiers: H14-01215RN325361
• Study Type: interventional
• Target: 79
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Obstructive Sleep Apnea

Keywords

Adherence; CPAP; Oral Appliance; Mandibular Advancement Splints; Preference

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (23)

• Apnea-hypopnea index

  At baseline

• Functional Outcomes of Sleep Questionnaire (FOSQ) responses

  At baseline

• Epworth Sleepiness Scale (ESS) questionnaire responses.

  At baseline

• Chalder fatigue scale questionnaire responses

  At baseline

• SF-36 survey responses

  At baseline

Study Arms (2)

MAS-PAP

ACTIVE COMPARATOR

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)

PAP-MAS

ACTIVE COMPARATOR

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)

Interventions

Positive Airway Pressure (PAP) DEVICE

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

MAS-PAP; PAP-MAS

Mandibular Advancement Splints (MAS) DEVICE

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

MAS-PAP; PAP-MAS

Eligibility Criteria

• Age: 19 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of British Columbia: lead
• Université de Montréal: collaborator
• Laval University: collaborator

Study Sites (3)

University of British Columbia

Vancouver, British Columbia, V6T 1Z3, Canada

Location

University of Montreal / Université de Montréal

Montreal, Quebec, H3T 1J4, Canada

Location

Laval University / Université Laval

Québec, G1V 4G5, Canada

Location

Related Publications (2)

• 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.

  PMID: 23585745 BACKGROUND

• 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.

  PMID: 33745505 DERIVED

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Interventions

Continuous Positive Airway Pressure; Occlusal Splints

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Positive-Pressure Respiration; Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy; Orthotic Devices; Orthopedic Equipment; Surgical Equipment; Equipment and Supplies

Study Officials

• Fernanda R Almeida, DDS, MSc, PhD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: August 29, 2014
• First Posted: September 17, 2014
• Study Start: November 1, 2015
• Primary Completion: June 1, 2020
• Study Completion: June 1, 2020
• Last Updated: November 30, 2022

Record last verified: 2022-11

Locations

CA (3)