Efficacy of the OrthoApnea NOA Mandibular Advancement Device in the Management of Obstructive Sleep Apnea.

  • STATUS
    Recruiting
  • End date
    Jul 31, 2023
  • participants needed
    50
  • sponsor
    Isabel Moreno Hay
Updated on 11 December 2021

Summary

The objective of this study is to assess the efficacy of the Orthoapnea NOA mandibular advancement device and describe the percentage of advancement (%) needed to reach efficacy, and to retrospectively compare with other MAD designs in the management of obstructive sleep apnea. Additionally, to describe patient compliance and adherence to the therapy with the Orthoapnea NOA device, and to assess the incidence and prevalence of signs, symptoms, and diagnosis of temporomandibular disorders (TMD) associated to the use of the Orthoapnea NOA mandibular advancement device.

Details
Condition obstructive sleep apnoea, Obstructive sleep apnea, obstructive sleep apnea syndrome
Treatment Orthoapnea NOA®
Clinical Study IdentifierNCT05139303
SponsorIsabel Moreno Hay
Last Modified on11 December 2021

Eligibility

Yes No Not Sure

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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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