A Randomised, Controlled Cross Over Study Comparing Two Mandibular Advancement Devices in the Treatment of Mild-to-moderate Obstructive Sleep Apnea
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 16
- Locations
- 1
- Primary Endpoint
- AHI
Study Overview
Brief Summary
The goal of this randomised, controlled cross-over study is to compare two mandibular repositioning devices (MRA) already on the market in the treatment of mild-to-moderate obstructive sleep apnea.
Patiënt will test the first MRA for 3 months, after a wash out period of 2 weeks they will test the second MRA for 3 months. It will be randomised what type of MRA will be tested first and second.
Detailed Description
A mandibular repositioning appliance (MRA) is the primary treatment option for patients with mild to moderate obstructive sleep apnea (OSA), as well as for those with severe OSA who are intolerant to continuous positive airway pressure (CPAP) therapy or for whom surgical interventions are not viable. MRAs function by advancing the mandible, thereby increasing the volume of the upper airway and reducing its tendency to collapse during sleep. Various types of MRAs are available, and multiple classification systems can be employed to distinguish between these different types.
Mandibular repositioning appliances (MRAs) can be either custom-made or universal. Custom-made devices, which are typically more expensive, are fabricated in a dental laboratory using dental impressions. In contrast, prefabricated devices, often thermoplastic MRAs, are generally less costly and readily available over the counter.
Mandibular repositioning appliances (MRAs) can be classified as non-titratable, also known as monoblock devices, which have a fixed position, or titratable devices, which allow for gradual adjustment of the mandibular position until the desired therapeutic effect is achieved. Current guidelines recommend the use of titratable MRAs.
Titratable mandibular repositioning appliances (MRAs) can be further categorized into two types: midline traction devices, where the upper and lower components are connected at the front of the device, and bilateral thrust devices, where the upper and lower components are linked in the lateral or (pre-)molar regions.
Within the latter category, various designs exist, including devices that are adjustable on both sides using Hyrax screws and 3D-printed devices equipped with a series of lower components that allow for adjustments in mandibular position.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •In order to be eligible to participate in this study, a subject must meet all of the following criteria:
- •Provide signed and dated informed consent
- •Males or females aged 18 and above
- •Apnea-Hypopnea Index (AHI) between 5 and 30 events per hour diagnosed by a polysomnography
- •A potential subject who meets any of the following criteria will be excluded from participation in this study:
- •Previous surgery on the upper airways
- •Prior treatment of OSA (CPAP or MRA)
- •Presence of unstable cardiovascular conditions, neurological, mental, or psychiatric disorders
- •Insufficient dental or periodontal condition for a mandibular repositioning appliance (MRA)
- •Presence of temporomandibular joint dysfunction
Exclusion Criteria
- Not provided
Arms & Interventions
MRA1MRA2
Use of MRA device 1 for 3 months, use of MRA device 2 for 3 months
Intervention: Polygraphy (Diagnostic Test)
MRA1MRA2
Use of MRA device 1 for 3 months, use of MRA device 2 for 3 months
Intervention: Questionaire (Other)
MRA1MRA2
Use of MRA device 1 for 3 months, use of MRA device 2 for 3 months
Intervention: Question (Other)
MRA2MRA1
Use of MRA device 2 for 3 months, use of MRA device 1 for 3 months
Intervention: Polygraphy (Diagnostic Test)
MRA2MRA1
Use of MRA device 2 for 3 months, use of MRA device 1 for 3 months
Intervention: Questionaire (Other)
MRA2MRA1
Use of MRA device 2 for 3 months, use of MRA device 1 for 3 months
Intervention: Question (Other)
Outcomes
Primary Outcomes
AHI
Time Frame: 3 monthts after use of first MRA (mandibular advancement device), 3 months after use of second MRA (mandibular advancement device)
Improvement of AHI (apnea-hypopnea index), measured by polygraphy before treatment and after treatment with each MRA. The goal of the mandibular advancement device is to reduce the number of apneas and hypopneas per hour, apneas are periods when a person stops breathing and hypopneas are instances where airflow is blocked, causing shallow breathing. This is measured by a polygraphy-test overnight at the patiënts home.
Secondary Outcomes
- Patient experience questionnaire(3 months after use of the first MRA, 3 months after use of the second MRA)
- Peripheral oxygen saturation 1(3 monthts after use of first MRA, 3 months after use of second MRA)
- Peripheral oxygen saturation 2(3 monthts after use of first MRA, 3 months after use of second MRA)
- Peripheral oxygen saturation 3(3 monthts after use of first MRA, 3 months after use of second MRA)
- ESS(3 monthts after use of first MRA, 3 months after use of second MRA)
- Final choice(after the use of each MRA for 3 months)
