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:
2025-12-24 @ 7:39 PM
Ignite Modification Date:
2025-12-24 @ 7:39 PM
NCT ID:
NCT05139303
Eligibility Criteria:
Inclusion Criteria:
* Age: \>18 and \<80 years old.
* No history of previous use of a MAD.
* Diagnosis of OSA by a sleep physician based on a PSG or HSAT (done \>12 months before evaluation date or \> 12 months with \>10% variation of BMI).
* Upon clinical examination: \>8 teeth per arch; range of anteroposterior mandibular mobility \>5 mm.
* Informed consent to participate in the study.
Exclusion Criteria:
* Patients with concomitant diagnosed sleep disorders (i.e. insomnia, narcolepsy, restless legs syndrome, rapid eye movement sleep behavior disorder).
* History of previous allergic reaction to the appliance material (Polyamide 12).
* Patients using combination therapy for the management of OSA (i.e. PAP therapy or positional therapy).
* Upon clinical examination: periodontal disease (\>4 mm on periodontal probing, with bleeding on probing, visual signs of periodontal inflammation); tooth horizontal mobility \>1 mm, vertical mobility, and unfavorable crown to root ratio; open cavities, loose or fractured restorations, or patient undergoing restorative dental treatments.
* Exaggerated gag reflex.
* Lack of coordination or dexterity.
* Inadequate English comprehension.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
79 Years
Study:
NCT05139303
Study Brief:
Protocol Section:
NCT05139303