Mandibular Advancement Device for Nocturia

(MAD Trial)

Overseen By Fernanda Yanez Regonesi, DDS, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Fernanda Yanez Regonesi

Must not be taking: Diuretics

Disqualifiers: Sleep disorders, Urological disease, Pregnancy, Heart failure, Diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 15 weeks

36 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a mandibular advancement device (MAD), a special mouthpiece that keeps the airway open, can reduce nocturia, the frequent need to urinate at night. The device under evaluation is the Somnodent Classic. Suitable candidates for this trial are English-speaking adults diagnosed with obstructive sleep apnea, a condition where breathing stops and starts during sleep, who experience at least two nighttime bathroom trips. As an unphased trial, this study allows participants to contribute to innovative research that could enhance sleep quality and reduce nighttime disruptions.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are using combination therapy for obstructive sleep apnea, such as positive airway pressure therapy, you may not be eligible to participate.

What prior data suggests that this mandibular advancement device is safe for nocturia?

Research shows that the Somnodent Classic, a device that moves the lower jaw forward, is generally easy to use. This device helps with sleep apnea by keeping the airway open during sleep. In earlier studies, 67% of users of a similar device reported positive results, indicating its effectiveness and safety for many.

Some reports of side effects exist. For example, one person reported a possible allergic reaction. However, such reports are rare, and the side effects are usually mild. The device's established use for sleep apnea also suggests reasonable safety.

Overall, while some side effects can occur, research and experience indicate that most people tolerate the device well. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Somnodent Classic is unique because it offers a non-invasive approach to managing nocturia by using a mandibular advancement device (MAD). Unlike standard treatments for nocturia, which often involve medications targeting bladder control or lifestyle changes, the Somnodent Classic works by adjusting the position of the jaw to potentially influence sleep quality and reduce nighttime awakenings. Researchers are excited about this treatment because it targets a novel aspect of nocturia by addressing sleep-disordered breathing, which is not the focus of current therapies. This could provide relief for individuals who do not respond well to traditional treatments.

What evidence suggests that the mandibular advancement device is effective for nocturia?

Research has shown that the Somnodent Classic, a type of mouthpiece, can help reduce frequent nighttime urination, known as nocturia. This trial will evaluate its effectiveness as a mandibular advancement device (MAD) therapy for nocturia. Studies have found these mouthpieces effective for treating sleep disorders like obstructive sleep apnea (OSA), which often links to nocturia. In one study, using devices like the Somnodent reduced sleep disruptions by an average of 40.5%. Another study found that people using these mouthpieces for OSA experienced long-term benefits, with a decrease in nocturia as an early sign of improvement. Although direct data on nocturia is limited, these findings suggest that the Somnodent Classic may help by improving sleep-related issues. ^{1 2 6 7 8}

Who Is on the Research Team?

Fernanda Yanez Regonesi, DDS, MS

Principal Investigator

University Of Kentucy

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Consent to participate in the study.

I am older than 18 years.

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

Exclusion Criteria

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

I struggle with coordination or using my hands.

Pregnancy

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are fitted with a mandibular advancement device (MAD) and undergo titration every 2 weeks until nocturia is reduced to less than 2 voidings per night.

15 weeks

Bi-weekly visits for titration

Follow-up

Participants are monitored for safety and effectiveness after treatment, including a second sleep study to assess treatment success.

4 weeks

1 visit (in-person) for sleep study

What Are the Treatments Tested in This Trial?

Interventions

• Somnodent Classic

Trial Overview 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.

How Is the Trial Designed?

Group I: MAD therapy Experimental Treatment 1 Intervention

MAD Therapy

Somnodent Classic is already approved in United States, Canada, European Union for the following indications:

Approved in United States as SomnoDent Classic for:

• Obstructive Sleep Apnea

Approved in Canada as SomnoDent Classic for:

• Obstructive Sleep Apnea

Approved in European Union as SomnoDent Classic for:

• Obstructive Sleep Apnea

Who Is Running the Clinical Trial?

Fernanda Yanez Regonesi

Lead Sponsor

Trials

1

Recruited

40+

American Academy of Dental Sleep Medicine

Collaborator

Trials

1

Recruited

40+

Published Research Related to This Trial

Mandibular advancement devices have been shown to significantly improve symptoms of obstructive sleep apnea syndrome (OSAS), particularly by reducing the frequency of apneas and hypopneas, which leads to better sleep quality and less snoring as reported by bed partners.

Polysomnographic improvements were noted, with some patients achieving an apnea-hypopnea index of less than 10 per hour, although results varied, with some individuals experiencing no improvement or worsening of their condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Mandibular advancement orthoses used in the treatment of obstructive sleep apnea syndrome]. Petitjean, T., Garcia Tejero, MT., Langevin, B., et al.[2006]

Mandibular advancement devices are effective in treating mild to moderate obstructive sleep apnea/hypopnea syndrome (OSAHS), significantly reducing the apnea/hypopnea index (AHI) and improving oxygen saturation, snoring, and daytime sleepiness based on a systematic review of 22 studies.

Custom-made and adjustable mandibular advancement devices provide better outcomes compared to fixed or prefabricated options, although monobloc devices may lead to more mild and transient adverse effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of mandibular advancement appliances in treating obstructive sleep apnea syndrome: A systematic review. Serra-Torres, S., Bellot-Arcís, C., Montiel-Company, JM., et al.[2022]

Mandibular advancement devices (MAD) significantly improved snoring and sleep-related breathing disorders in 11 patients, with the snoring index decreasing from 108 to 53 events per hour and the apnea-hypopnea index improving from 15 to 5.5 events per hour.

The study demonstrated good tolerability of the MAD among most patients, with 10 out of 11 participants accepting the device well, highlighting its potential as an effective treatment for snoring and obstructive sleep apnea.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Objective assessment and therapeutic efficacy of an improved mandibular advancement device for snoring and sleep apnea syndromes with polysomnography]. Saletu, A., Gritsch, F., Mailath-Pokorny, G., et al.[2019]

In a pilot study of 20 heavy snorers, the Somnoguard mandibular advancement device (MAD) showed a 65% success rate in reducing the apnea-hypopnea index (AHI) by at least 50%, indicating its efficacy in treating mild obstructive sleep apnea (OSA).

The use of the MAD led to significant reductions in both the snoring index and the Epworth Sleepiness Scale scores at both 1-month and 6-month follow-ups, demonstrating its effectiveness and good tolerance as a non-invasive treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pilot study of a novel mandibular advancement device for the control of snoring. Vanderveken, OM., Boudewyns, AN., Braem, MJ., et al.[2019]

The mandibular advancement device (MAD) Somnoguard significantly reduced the respiratory disturbance index (RDI) in 44 patients with obstructive sleep apnea (OSA), indicating improved breathing during sleep.

68% of patients experienced either a cure or substantial improvement in their condition, along with a notable increase in minimal oxygen saturation and a decrease in snoring time, demonstrating the device's efficacy as an alternative treatment for those noncompliant with continuous positive airway pressure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A mandibular advancement device for the ENT office to treat obstructive sleep apnea. Maurer, JT., Huber, K., Verse, T., et al.[2013]

Mandibular advancement devices have been shown to significantly improve symptoms of obstructive sleep apnea syndrome (OSAS), particularly by reducing the frequency of apneas and hypopneas, which leads to better sleep quality and less snoring as reported by bed partners.

Polysomnographic improvements were noted, with some patients achieving an apnea-hypopnea index of less than 10 per hour, although results varied, with some patients experiencing no improvement or worsening of symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Mandibular advancement orthotic for treatment of obstructive sleep apnea]. Petitjean, T., Garcia Tejero, MT., Langevin, B., et al.[2006]

Mandibular advancement devices (MADs) for treating obstructive sleep apnea can lead to specific dental changes, such as a slight increase in lower incisor proclination and a decrease in overjet and overbite, based on a review of 14 studies including both randomized and non-randomized trials.

The devices also cause skeletal changes, including a downward and forward rotation of the mandible and a minor increase in the SNA angle, indicating that while MADs are effective for OSA, they can have notable effects on dental and skeletal structures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dental and Skeletal Side Effects of Oral Appliances Used for the Treatment of Obstructive Sleep Apnea and Snoring in Adult Patients-A Systematic Review and Meta-Analysis. Tsolakis, IA., Palomo, JM., Matthaios, S., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05562388

Mandibular Advancement Device and Changes in Nocturia ... Device : Somnodent Classic. The efficacy of the device will be evaluated in regards to the response of nocturia. Once patients report an average of voiding ...

2. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05562388/mandibular-advancement-device-and-changes-in-nocturia

Mandibular Advancement Device and Changes in Nocturia The main purpose of this study is to test is mandibular advacenment device (MAD) use is associated with reductions in nocturia.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6490037/

Randomized controlled trial of an oral appliance (SomnoDent ... Randomized controlled trial of an oral appliance (SomnoDent) for sleep‐disordered breathing and cardiac function in patients with heart failure.

4. sciencedirect.com sciencedirect.com/science/article/pii/S1389945716302076

Predictors of long-term effectiveness to mandibular ... Conclusions. After three years, MRD was effective for the two-thirds of OSA patients who continued treatment. Relapse of nocturia might be an early signal of ...

5. researchgate.net researchgate.net/publication/356544137_Efficacy_of_SomnodentR_Appliance_Therapy_in_Moderate_to_Severe_Obstructive_Sleep_Apnea_Patients_SomnodentR_OAs_for_Moderate_to_Severe_OSAHS

Efficacy of Somnodent® Appliance Therapy in Moderate to ... Oral appliance treatment significantly improved patients' AHI, reducing AHI by an average of 40.5% (follow-up mean 11.9±22.1, p<0.001) as well ...

6. somnomed.com somnomed.com/en/physicians/clinical/

Clinical | SomnoMed US We have helped individual patients on their journey in finding a solution. Find out what they went through and how it feels to wear a SomnoDent oral appliance.

7. accessdata.fda.gov accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5683590&pc=LRK

MAUDE Adverse Event Report: SOMNOMED INC ... From the fda forwarded, voluntary report from the patient, somnomed initially suspected a hypersensitivity reaction.

8. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38518588/

Comparative analysis of two custom-made mandibular ... Results: These real-world data set showed that 67% of patients achieved treatment success, with a statistically significant reduction in AHI from 22.8 [17.7 ...