A Study Comparing Two Mandibular Advancement Devices in the Treatment of Sleep Apnea

NCT06810479 | Not Yet Recruiting

• 1 other identifier: Z-2025010
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Apnea, Obstructive

Keywords

sleep apnea; MRA; mandibular repositioning appliance

Outcome Measures

Primary Outcomes (1)

• AHI

  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.

  3 monthts after use of first MRA (mandibular advancement device), 3 months after use of second MRA (mandibular advancement device)

Secondary Outcomes (6)

• 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

• Patient experience questionnaire

  3 monthts after use of first MRA, 3 months after use of second MRA

Study Arms (2)

MRA1MRA2

EXPERIMENTAL

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

Diagnostic Test: Polygraphy; Other: Questionaire; Other: Question

MRA2MRA1

EXPERIMENTAL

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

Diagnostic Test: Polygraphy; Other: Questionaire; Other: Question

Interventions

Polygraphy DIAGNOSTIC_TEST

Polygraphy will be caried out at the patients home to evaluate each MRA after 3 monhts

MRA1MRA2; MRA2MRA1

Questionaire OTHER

Epworth Sleepiness Scale o Johns, Murray W. "A New Method for Measuring Daytime Sleepiness: The Epworth Sleepiness Scale." Sleep, vol. 14, no. 6, 1991, pp. 540-545.

MRA1MRA2; MRA2MRA1

Question OTHER

Patient final choice of preferred MRA

MRA1MRA2; MRA2MRA1

Eligibility Criteria

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

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Ziekenhuis Oost-Limburg: lead

Related Publications (11)

• Ng ET, Perez-Garcia A, Lagravere-Vich MO. Development and initial validation of a questionnaire to measure patient experience with oral appliance therapy. J Clin Sleep Med. 2023 Aug 1;19(8):1437-1445. doi: 10.5664/jcsm.10562.

  PMID: 37082817 BACKGROUND

• Johns MW. A new method for measuring daytime sleepiness: the Epworth sleepiness scale. Sleep. 1991 Dec;14(6):540-5. doi: 10.1093/sleep/14.6.540.

  PMID: 1798888 BACKGROUND

• Zhou J, Liu YH. A randomised titrated crossover study comparing two oral appliances in the treatment for mild to moderate obstructive sleep apnoea/hypopnoea syndrome. J Oral Rehabil. 2012 Dec;39(12):914-22. doi: 10.1111/joor.12006. Epub 2012 Sep 27.

  PMID: 23016888 BACKGROUND

• Vezina JP, Blumen MB, Buchet I, Hausser-Hauw C, Chabolle F. Does propulsion mechanism influence the long-term side effects of oral appliances in the treatment of sleep-disordered breathing? Chest. 2011 Nov;140(5):1184-1191. doi: 10.1378/chest.10-3123. Epub 2011 May 26.

  PMID: 21622552 BACKGROUND

• Shi X, Lobbezoo F, Chen H, Rosenmoller BRAM, Berkhout E, de Lange J, Aarab G. Comparisons of the effects of two types of titratable mandibular advancement devices on respiratory parameters and upper airway dimensions in patients with obstructive sleep apnea: a randomized controlled trial. Clin Oral Investig. 2023 May;27(5):2013-2025. doi: 10.1007/s00784-023-04945-z. Epub 2023 Mar 17.

  PMID: 36928350 BACKGROUND

• Lawton HM, Battagel JM, Kotecha B. A comparison of the Twin Block and Herbst mandibular advancement splints in the treatment of patients with obstructive sleep apnoea: a prospective study. Eur J Orthod. 2005 Feb;27(1):82-90. doi: 10.1093/ejo/cjh067.

  PMID: 15743867 BACKGROUND

• Uniken Venema JAM, Rosenmoller BRAM, de Vries N, de Lange J, Aarab G, Lobbezoo F, Hoekema A. Mandibular advancement device design: A systematic review on outcomes in obstructive sleep apnea treatment. Sleep Med Rev. 2021 Dec;60:101557. doi: 10.1016/j.smrv.2021.101557. Epub 2021 Oct 1.

  PMID: 34662769 BACKGROUND

• Schmidt-Nowara W, Lowe A, Wiegand L, Cartwright R, Perez-Guerra F, Menn S. Oral appliances for the treatment of snoring and obstructive sleep apnea: a review. Sleep. 1995 Jul;18(6):501-10. doi: 10.1093/sleep/18.6.501.

  PMID: 7481421 BACKGROUND

• Dieltjens M, Vanderveken O. Oral Appliances in Obstructive Sleep Apnea. Healthcare (Basel). 2019 Nov 8;7(4):141. doi: 10.3390/healthcare7040141.

  PMID: 31717429 BACKGROUND

• Almeida FR, Lowe AA. Principles of oral appliance therapy for the management of snoring and sleep disordered breathing. Oral Maxillofac Surg Clin North Am. 2009 Nov;21(4):413-20. doi: 10.1016/j.coms.2009.07.002.

  PMID: 19944341 BACKGROUND

• Ramar K, Dort LC, Katz SG, Lettieri CJ, Harrod CG, Thomas SM, Chervin RD. Clinical Practice Guideline for the Treatment of Obstructive Sleep Apnea and Snoring with Oral Appliance Therapy: An Update for 2015. J Clin Sleep Med. 2015 Jul 15;11(7):773-827. doi: 10.5664/jcsm.4858.

  PMID: 26094920 BACKGROUND

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Sleep Apnea Syndromes

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Joeri Meyns, MD, DDS

CONTACT

+3289 32 50 50; joeri.meyns@zol.be

Adriaan Blok, MD, DDS

CONTACT

+3289 32 50 50; adriaanjohannes.blok@zol.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: randomised, controlled cross over study comparing two mandibular advancement devices

Study Record Dates

• First Submitted: January 24, 2025
• First Posted: February 5, 2025
• Study Start: March 20, 2025
• Primary Completion: January 31, 2026
• Study Completion: April 1, 2026
• Last Updated: March 21, 2025

Record last verified: 2025-01