What side effects are associated with this type of intervention?

The most common treatments for Obstructive Sleep Apnea (OSA) include Continuous Positive Airway Pressure (CPAP) therapy, Mandibular Advancement Devices (MAD), and surgical interventions. CPAP therapy can cause side effects such as nasal congestion, dry mouth, and skin irritation from the mask. Mandibular Advancement Devices (MAD), which advance the lower jaw to keep the airway open, can lead to jaw discomfort, dental misalignment, and excessive salivation. Surgical treatments, though less common, carry risks of infection, pain, and complications from anesthesia. Each treatment option has its own set of potential side effects, and the choice of therapy should be individualized based on patient-specific factors and preferences.

What prior FDA approvals exist?

The FDA has approved several treatments for Obstructive Sleep Apnea (OSA), including Continuous Positive Airway Pressure (CPAP) machines, which are the most common and effective treatment. Mandibular Advancement Devices (MADs) are another FDA-approved option, designed to advance the lower jaw and keep the airway open, thereby improving sleep quality and reducing symptoms like nocturia. While pharmacologic agents have been investigated, none have proven sufficiently effective to replace these mechanical therapies. The FDA's approval of MADs provides a non-invasive alternative for patients who cannot tolerate CPAP therapy.

What other types of research exist?

Promising novel alternatives to Mandibular Advancement Device (MAD) for Obstructive Sleep Apnea (OSA) patients include: 1) Continuous Positive Airway Pressure (CPAP) therapy, which remains the gold standard for OSA treatment. 2) Auto-CPAP (APAP) devices, which automatically adjust pressure levels throughout the night. 3) Hypoglossal nerve stimulation, a surgical option that stimulates the nerve controlling tongue movement to keep the airway open. 4) Positional therapy devices, which help patients avoid sleeping on their back, a common position that exacerbates OSA. 5) Emerging pharmacological treatments targeting the underlying pathophysiology of OSA, though these are still under investigation.

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Device

Mandibular Advancement Device for Nocturia (MAD Trial)

N/A

Recruiting

Led By Fernanda Yanez Regonesi, DDS, MS

Research Sponsored by Fernanda Yanez Regonesi

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age >18

Upon clinical examination ≥ 8 teeth per arch, range of mandibular protrusion ≥5 mm

Must not have

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

Lack of coordination or dexterity

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 15 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial tests if a mouthpiece that keeps the lower jaw forward can help people who frequently urinate at night by improving their sleep. These devices have been used to help with breathing issues during sleep.

Who is the study for?

This trial is for adults over 18 with obstructive sleep apnea (AHI≥5) who experience at least two trips to the bathroom per night. Participants must have ≥8 teeth per arch, be able to move their jaw forward by ≥5mm, and speak English. People can't join if they're pregnant, have certain medical conditions like heart failure or diabetes, use diuretics, or are already using other treatments for sleep apnea.

What is being tested?

The study is examining whether a mandibular advancement device (MAD), specifically the Somnodent Classic model, can reduce nighttime urination (nocturia) in people with obstructive sleep apnea.

What are the potential side effects?

Potential side effects of using a MAD may include discomfort in the jaw, teeth or gums; excessive salivation or dry mouth; temporary changes in bite alignment upon waking; and possible aggravation of temporomandibular joint disorders.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am older than 18 years.

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I have at least 8 teeth in each jaw and can move my lower jaw forward by 5 mm or more.

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I have been diagnosed with obstructive sleep apnea.

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I go to the bathroom to urinate 2 or more times at night.

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I have at least 8 teeth per arch and can move my lower jaw forward by 5 mm.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have severe gum disease, loose teeth, cavities, or am getting dental treatments.

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I struggle with coordination or using my hands.

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I have been diagnosed with a sleep disorder such as insomnia or narcolepsy.

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I use a device or special position to manage my sleep apnea.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 15 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~15 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 15 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Nocturia

Secondary study objectives

Nocturia

Other study objectives

Fatigue

Sleeplessness

Changes in quality of life

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: MAD therapyExperimental Treatment1 Intervention

MAD Therapy

0 / 9Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Obstructive Sleep Apnea (OSA) include Continuous Positive Airway Pressure (CPAP) and Mandibular Advancement Devices (MAD). CPAP works by delivering a constant stream of air through a mask to keep the airway open during sleep, preventing apneas and hypopneas. MADs advance the lower jaw forward, which helps to keep the airway open by preventing the collapse of the soft tissues in the throat. These treatments are essential for OSA patients as they improve sleep quality, reduce symptoms like daytime sleepiness and nocturia, and lower the risk of complications such as cardiovascular issues and neuropsychiatric dysfunction.

Oral appliance therapy in obstructive sleep apnea and snoring - systematic review and new directions of development.