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 October 04, 2024

Not yet recruiting

Keywords

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

Description

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

About Sponsor

The National Institute of Allergy and Infectious Diseases (NIAID, /ˈnaɪ.æd/) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services (HHS). NIAID's mission is to conduct basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases.

Contacts

JC

Jennifer Cobb

Immunology at National Institute of Allergy and Infectious Diseases (NIAID)

Locations

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0