Status:
COMPLETED
Oral Appliances With and Without Elastic Bands to Treat Obstructive Sleep Apnea: A Randomized Crossover Trial
Lead Sponsor:
University of Bergen
Collaborating Sponsors:
Haukeland University Hospital
Conditions:
Sleep Apnea, Obstructive
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The goal of this randomized crossover trial is to investigate the effect of elastic bands attached to oral appliances to minimize mouth opening during sleep in obstructive sleep apnea (OSA) patients. ...
Detailed Description
69 patients with moderate or severe OSA referred to Center of Sleep Medicine, Haukeland University Hospital (HUS), for oral appliance treatment will be invited to participate in the study. The oral a...
Eligibility Criteria
Inclusion
- Moderate or severe OSA
- Non-compliant and/or non-responder to CPAP-treatment
- Considered for treatment with Somnodent Fusion (second line oral appliance - indicated when retention on remaining teeth is insufficient to retain Narval CC)
- Participate in the "Sleep registry" at Center for Sleep Medicine, Haukeland University Hospital
Exclusion
- Mild OSA or no OSA
- Considered for treatment with Narval CC (first line oral appliance)
- Patients with insufficient amount of teeth to retain an oral appliance
- Patients with full denture
- Patients that do not speak and/or read Norwegian language
- Patients that are not competent to give informed consent
Key Trial Info
Start Date :
April 15 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 3 2024
Estimated Enrollment :
69 Patients enrolled
Trial Details
Trial ID
NCT05987618
Start Date
April 15 2023
End Date
March 3 2024
Last Update
May 9 2024
Active Locations (1)
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1
Center of Sleep Medicine, Haukeland University Hospital
Bergen, Norway, 5021