Search / Trial NCT06612008

Superimposition of Intra-oral Scans in MAD Therapy for OSA

Launched by AMSTERDAM UMC, LOCATION VUMC · Sep 20, 2024

Trial Information

Current as of December 21, 2024

Not yet recruiting

Keywords

Obstructive Sleep Apnea Obstructive Sleep Apnea Syndrome Oral Appliance Therapy Mandibular Advancement Device

ClinConnect Summary

Rationale: Obstructive Sleep Apnea (OSA) significantly reduces quality of life and increases the risk of severe health issue. While Mandibular Advancement Devices (MAD) are effective in managing OSA symptoms, they often introduce undesirable dental and skeletal changes, which can have a negative impact on patient satisfaction. Recognizing this issue, this study hypothesizes that using an innovative 3D superimposition technique to track these changes will allow to compare two different titration protocols more precisely and determine the optimal approach for various patient groups. By identi...

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Adults ≥ 18 years of age
  • Patients with a diagnosis of OSA
  • Patients with an apnea-hypopnea index (AHI) of 5 until 30 events per hour
  • Patients initially treated with MAD
  • Exclusion Criteria:
  • Patients under 18 years of age
  • Patients without a diagnosis of mild to moderate OSA
  • Patients undergoing other treatments for OSA
  • Patients previously undergone MAD treatment (this also includes over the counter boil and bite MADs)
  • Patients diagnosed with central sleep apnea
  • Patients undergoing orthodontic treatment (e.g. braces)
  • Pregnant patients
  • Patients with craniofacial anomalies or syndromes (e.g., Treacher-Collins, Down, Pierre-Robin, Marfan),
  • Patients undergoing cancer treatment with chemotherapy or radiation
  • Patients with a history of maxillofacial surgery
  • Patients with select dental conditions like severe periodontal disease, temporomandibular joint disease, insufficient dentition to support appliance retention in the mouth
  • Patients who use bone resorption inhibitors (such as bisphosphonates, calcitonin, SERMs) or the prolonged use, ≥ 6 months of corticosteroids

Trial Officials

J. de Lange, Prof. Dr.

Principal Investigator

Amsterdam University Medical Center

J.P.T.F. Ho, Dr.

Principal Investigator

Amsterdam University Medical Center

N.C.W. van der Kaaij, Dr.

Principal Investigator

Amsterdam University Medical Center

About Amsterdam Umc, Location Vumc

Amsterdam UMC, located at VU Medical Center (VUmc), is a leading academic medical center in the Netherlands dedicated to advancing healthcare through innovative research and clinical trials. With a strong emphasis on translating scientific discoveries into practical applications, Amsterdam UMC collaborates closely with researchers, healthcare professionals, and industry partners to enhance patient outcomes. The institution is committed to rigorous ethical standards and regulatory compliance, ensuring the integrity and reliability of its clinical research initiatives across various medical disciplines.

Locations

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0