Phase
Condition
Nocturia
Sleep Apnea Syndromes
Treatment
Somnodent Classic
Clinical Study ID
Ages 18-80 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
English speaker
>18 y/o
Obstructive sleep apnea diagnosis with AHI≥5
≥ 2 voiding/night at baseline
Upon clinical examination ≥ 8 teeth per arch, range of mandibular protrusion ≥5 mm
Consent to participate in the study.
Exclusion
Exclusion Criteria:
Patients with concomitant diagnosed sleep disorders (i.e. insomnia, narcolepsy,restless legs syndrome, rapid eye movement sleep behavior disorder).
Prostate/kidney problems (urological disease: (eg overactive bladder, benignprostate hyperplasia)
Pregnancy
Heart failure, use of diuretics, diabetes, Parkinson's disease or dementia.
Patients using combination therapy for the management of obstructive sleep apnea (OSA) (i.e. positive airway pressure (PAP) therapy or positional therapy).
Upon clinical examination: periodontal disease (>4 mm on periodontal probing, withbleeding on probing, visual signs of periodontal inflammation); tooth horizontalmobility >1 mm, vertical mobility, and unfavorable crown to root ratio; opencavities, loose or fractured restorations, or patient undergoing restorative dentaltreatments.
Exaggerated gag reflex.
Lack of coordination or dexterity.
Inadequate English comprehension.
Study Design
Study Description
Connect with a study center
University of Kentucky
Lexington, Kentucky 40536
United StatesActive - Recruiting
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