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 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.

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.

Is the Mandibular Advancement Device safe for humans?

Mandibular advancement devices, like Somnodent, are generally well-tolerated and considered safe for treating conditions like snoring and sleep apnea. Some studies report good acceptance and minor side effects, but there can be dental and skeletal changes over time. ^{1 2 3 4 5}

How does the treatment Somnodent Classic differ from other treatments for nocturia?

The Somnodent Classic is a mandibular advancement device, typically used for sleep apnea, that works by adjusting the position of the lower jaw to improve airflow during sleep. This approach is unique for nocturia (frequent nighttime urination) as it is non-invasive and primarily targets sleep-related breathing issues, which may indirectly affect nocturia symptoms. ^{1 2 3 6 7}

What data supports the effectiveness of the treatment Somnodent Classic for nocturia?

Mandibular advancement devices, like Somnodent Classic, have been shown to improve sleep quality and reduce snoring in people with obstructive sleep apnea, which might indirectly help with nocturia (frequent nighttime urination) by improving overall sleep patterns. ^{1 2 3 6 7}

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 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]

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 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]

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]

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]

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. France pubmed.ncbi.nlm.nih.gov

[Mandibular advancement orthoses used in the treatment of obstructive sleep apnea syndrome]. [2006]

2. France pubmed.ncbi.nlm.nih.gov

[Mandibular advancement orthotic for treatment of obstructive sleep apnea]. [2006]

3. England pubmed.ncbi.nlm.nih.gov

A mandibular advancement device for the ENT office to treat obstructive sleep apnea. [2013]

4. United States pubmed.ncbi.nlm.nih.gov

Effectiveness of mandibular advancement appliances in treating obstructive sleep apnea syndrome: A systematic review. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Pilot study of a novel mandibular advancement device for the control of snoring. [2019]

6. Austria pubmed.ncbi.nlm.nih.gov

[Objective assessment and therapeutic efficacy of an improved mandibular advancement device for snoring and sleep apnea syndromes with polysomnography]. [2019]

7. Switzerland 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. [2022]