Mandibular Advancement Device and Changes in Nocturia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-11

Study Completion Date

2026-03-12

Brief Summary

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The main purpose of this study is to test is mandibular advacenment device (MAD) use is associated with reductions in nocturia.

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Detailed Description

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After been informed about the study and informed about risks and benefits, participants will be fitted with a MAD and will be asked to completed questionnaires at baseline, in between follow ups and during follow ups. Nocturia will be assess and appliance will be titrated every 2 weeks until participants report less than 2 voiding per night according to the daily dairies. At that point, second sleep study with MAD in place will be performed to assess treatment effectiveness.

Conditions

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Obstructive Sleep Apnea Nocturia OSA

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Uncontrolled open label clinical trial. Data gathers from recruitment until appliance delivery will be used allowing each participant to also be their own control, as wait list type of study.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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MAD therapy

MAD Therapy

Group Type EXPERIMENTAL

Somnodent Classic

Intervention Type DEVICE

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.

Interventions

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Somnodent Classic

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.

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No