Mandibular Advancement Device and Changes in Nocturia
Improvement in Nocturia With MAD and Changes in Polysomnographic Value
Fernanda Yanez Regonesi
36 participants
Dec 11, 2023
INTERVENTIONAL
Conditions
Summary
The main purpose of this study is to test is mandibular advacenment device (MAD) use is associated with reductions in nocturia.
Eligibility
Inclusion Criteria6
- 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 Criteria9
- 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.
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Interventions
The efficacy of the device will be evaluated in regards to the response of nocturia. Once patients report an average of voiding per night of less than 2 in the preceding 2 weeks of the follow up they will be classified as responders in term of nocturia and will be evaluated with a second sleep study. Efficacy of MAD will be assessed by comparing the apnea hypopnea index (AHI) values of pre and post sleep study with MAD, and they will be classified as responders if they have 50% improvement in AHI.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT05562388