Skip to main content
Clinical Trials/NCT06810479
NCT06810479CompletedNot Applicable

A Randomised, Controlled Cross Over Study Comparing Two Mandibular Advancement Devices in the Treatment of Mild-to-moderate Obstructive Sleep Apnea

Ziekenhuis Oost-Limburg1 site in 1 country16 target enrollmentStarted: March 21, 2025Last updated:
Conditions
Interventions

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

Experimental

Use of MRA device 1 for 3 months, use of MRA device 2 for 3 months

Intervention: Polygraphy (Diagnostic Test)

MRA1MRA2

Experimental

Use of MRA device 1 for 3 months, use of MRA device 2 for 3 months

Intervention: Questionaire (Other)

MRA1MRA2

Experimental

Use of MRA device 1 for 3 months, use of MRA device 2 for 3 months

Intervention: Question (Other)

MRA2MRA1

Experimental

Use of MRA device 2 for 3 months, use of MRA device 1 for 3 months

Intervention: Polygraphy (Diagnostic Test)

MRA2MRA1

Experimental

Use of MRA device 2 for 3 months, use of MRA device 1 for 3 months

Intervention: Questionaire (Other)

MRA2MRA1

Experimental

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)

Investigators

Sponsor
Ziekenhuis Oost-Limburg
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

Loading locations...

Similar Trials