Mandibular Advancement Device and Changes in Nocturia (NCT05562388) | Clinical Trial Compass
CompletedNot Applicable
Mandibular Advancement Device and Changes in Nocturia
United States11 participantsStarted 2023-12-11
Plain-language summary
The main purpose of this study is to test is mandibular advacenment device (MAD) use is associated with reductions in nocturia.
Who can participate
Age range18 Years – 80 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 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, benign prostate 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, 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.