Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:30 AM
Ignite Modification Date:
2025-12-25 @ 4:30 AM
NCT ID:
NCT05987618
Eligibility Criteria:
Inclusion Criteria:
* 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 Criteria:
* 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05987618
Study Brief:
Protocol Section:
NCT05987618