Mouth Tape for Snoring and Sleep Apnea

(MTASSA Trial)

Overseen By Athena Mavronis

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Johns Hopkins University

Disqualifiers: Chronic lung disease, Pregnancy, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 3 months

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether silicone mouth tape can reduce snoring and improve sleep quality by promoting nose breathing instead of mouth breathing. Snoring can disturb sleep and lead to issues like dry mouth and heart problems. The trial includes individuals who snore or have mild obstructive sleep apnea, confirmed by a sleep study. Participants should have a history of snoring and a bed partner who can report on their snoring patterns. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to important findings.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this mouth tape is safe for snoring and mild sleep apnea?

Research has shown that using silicone mouth tape while sleeping can reduce snoring and lessen mild obstructive sleep apnea (OSA). One study found that mouth taping significantly reduced snoring and improved breathing for individuals who breathe through their mouths at night, though it involved only a small group. Some individuals use mouth tape without issues, but experts advise caution. Insufficient research exists to confirm its long-term safety and effectiveness. Mouth taping is still under study to understand its overall impact on sleep quality and its effects on bed partners. Currently in the second phase of trials, this treatment has shown promise, but more evidence is needed to confirm its safety for everyone. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about silicone mouth tape for snoring and sleep apnea because it offers a simple, non-invasive alternative to traditional treatments like CPAP machines or oral appliances. Unlike these standard options, which can be bulky and uncomfortable, silicone mouth tape gently encourages nasal breathing by keeping the mouth closed during sleep. This unique approach could provide relief for those with mild sleep apnea or simple snoring without the need for cumbersome equipment, making it a potentially more convenient and comfortable solution.

What evidence suggests that mouth tape might be an effective treatment for snoring and mild sleep apnea?

Research has shown that using mouth tape while sleeping might help reduce snoring and improve conditions for people with mild obstructive sleep apnea (OSA). In this trial, participants will use Silicone Mouth Tape to assess its effectiveness. One study found that mouth taping reduced both snoring and the severity of sleep apnea by about half in people who breathe through their mouths. Other small studies suggest that mouth tape can also lessen daytime tiredness for those with mild OSA. Although the evidence is limited and mixed, early results are promising for those who struggle with snoring. It is important to note that some sources warn about possible risks, so consulting a healthcare provider before trying it is advisable. ^{1 6 7 8 9}

Who Is on the Research Team?

Jonathan Jun, MD

Principal Investigator

Johns Hopkins University

Are You a Good Fit for This Trial?

This trial is for individuals who snore or have mild sleep apnea, which hasn't been resolved by lifestyle changes or other treatments. Participants should not be using CPAP machines or have conditions that might interfere with the study.

Inclusion Criteria

I have had a sleep study showing I either don't have sleep apnea or it's mild.

I am an adult with a BMI of 35, I snore, and have someone who can confirm my snoring.

Exclusion Criteria

I have had surgery on my tonsils, palate, or tongue.

I have chronic or acute breathing problems.

Patients must be able to tolerate breathing through their nose with the mouth tape in place for at least 3 minutes

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use silicone mouth tape during sleep to assess its impact on snoring and mild sleep apnea

3 months

Baseline, 2 weeks, and 3 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Silicone Mouth Tape

Trial Overview The study tests if mouth tape can help reduce snoring and improve sleep quality in people with mild sleep apnea. It will measure the effects on both the person who snores and their bed partner's experience.

How Is the Trial Designed?

Group I: Simple snorers or Mild Sleep Apnea Experimental Treatment 1 Intervention

Patients with snoring and a prior sleep study showing an AHI \< 15.

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

Published Research Related to This Trial

In a study involving 26 patients, the optically stimulating eye-cover and the tongue-retainer did not significantly improve the severity of obstructive sleep apnea or snoring, as measured by various sleep indices.

Despite the intended benefits, both devices failed to enhance patients' quality of sleep and life, and the tongue-retainer was associated with considerable adverse effects, indicating potential safety concerns.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Optical stimulation method (Snore-Stop) and tongue retainer (Snore-Master) without relevance in therapy of obstructive sleep apnea and snoring]. Wenzel, M., Schönhofer, B., Wenzel, G., et al.[2009]

In a study of 60 patients, using an oral appliance for 3 weeks significantly reduced the frequency and loudness of snoring, indicating its effectiveness in treating palatal snoring.

The oral appliance also led to a decrease in oxygen desaturation events during sleep, suggesting it may help alleviate sleep apnea symptoms as well.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does an oral appliance reduce palatal flutter and tongue base snoring? Stouder, S., Jones, L., Brietzke, S., et al.[2007]

In a study of 23 subjects with sleep-disordered breathing, 74% experienced noncompliance with the SnorEx oral device due to local side effects and lack of improvement in daytime well-being and respiratory disturbance index.

Only 26% of subjects tolerated the device well and showed significant improvements in their sleep-related symptoms, indicating that the high noncompliance and low overall efficacy limit the use of this treatment for sleep-disordered breathing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A new tongue advancement technique for sleep-disordered breathing: side effects and efficacy. Schönhofer, B., Stoohs, RA., Rager, H., et al.[2007]

About 51% of patients with mild-to-moderate obstructive sleep apnea continued using the anterior mandibular positioning (AMP) device for three years or more, indicating a significant drop-off in compliance over time.

While many users reported satisfaction with the AMP device, 40% experienced complications such as jaw pain and occlusal changes, highlighting the need for regular dental follow-ups to monitor these potential issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treating obstructive sleep apnea and snoring: assessment of an anterior mandibular positioning device. Clark, GT., Sohn, JW., Hong, CN.[2019]

In a study involving 77 chronic snorers, 77.9% of participants experienced a reduction in snoring after using a custom-fitted intra-oral vestibular shield made from a heat-malleable material.

Among those who did not benefit, some had nasal obstructions or dropped out due to lack of motivation, suggesting that while the device is effective for many, individual factors may influence its success and further research is needed for its use in obstructive sleep apnea.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical trial of an oral vestibular shield for the control of snoring. Veres, E.[2004]

The porous oral patch (POP) significantly improved sleep quality in patients with mild obstructive sleep apnea (OSA) and habitual open-mouth breathing, as evidenced by a decrease in the apnea-hypopnea index (AHI) from 12.0 to 7.8 events per hour (P < .01).

Subjective measures of sleepiness and snoring intensity also improved, with the Epworth Sleepiness Scale (ESS) score dropping from 8.1 to 5.2 and the visual analog scale (VAS) for snoring decreasing from 7.5 to 2.4 (both P < .05), indicating enhanced overall sleep experience.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Novel porous oral patches for patients with mild obstructive sleep apnea and mouth breathing: a pilot study. Huang, TW., Young, TH.[2022]

Mouth-taping during sleep significantly improved the severity of obstructive sleep apnea (OSA) in 20 mouth-breathing patients, reducing the apnea/hypopnea index (AHI) by 47% from 8.3 to 4.7 events per hour.

65% of participants showed a good response to mouth-taping, with notable reductions in snoring and oxygen desaturation, suggesting that this method could be a viable alternative treatment for mild OSA before considering CPAP or surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Impact of Mouth-Taping in Mouth-Breathers with Mild Obstructive Sleep Apnea: A Preliminary Study. Lee, YC., Lu, CT., Cheng, WN., et al.[2022]

In a study of 57 subjects with habitual loud snoring and obstructive sleep apnea (OSA), the use of a mandibular advancement splint (MAS) significantly reduced the apnea-hypopnea index (AHI) from an average of 32.2 to 17.5, indicating improved OSA severity.

The MAS also decreased the frequency and intensity of snoring, with the number of snores per sleep minute dropping from 11.0 to 9.0 and the percentage of loud snores (≥50 dB) decreasing from 42.0% to 26.2%, demonstrating its efficacy in managing both snoring and OSA.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mandibular advancement splint: an appliance to treat snoring and obstructive sleep apnea. O'Sullivan, RA., Hillman, DR., Mateljan, R., et al.[2015]

Mandibular repositioning devices can effectively treat simple snoring and mild to moderate obstructive sleep apnoea (OSA), and dentists can provide these devices with proper training.

This paper aims to guide dentists in safely screening patients to distinguish between those who can be treated for snoring and those who need referral for specialist assessment, enhancing patient safety and care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Snoring and the role of the GDP: British Society of Dental Sleep Medicine (BSDSM) pre-treatment screening protocol. Stradling, J., Dookun, R.[2009]

Long-term use of the Thornton Adjustable Positioner (TAP) for over two years in patients with obstructive sleep apnea resulted in statistically significant dental changes, including a reduction in overbite and tipping of the front teeth.

Out of 47 patients, 24 continued using the TAP for an average of 33 months, with nearly half experiencing a notable decrease in frontal overbite, indicating that while the dental side effects are small, they are clinically relevant and should be assessed individually.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dental side effects of mandibular advancement appliances - a 2-year follow-up. Ghazal, A., Jonas, IE., Rose, EC.[2016]

In a study of 106 patients with habitual snoring, treatment with three polyester implants in the soft palate resulted in most patients reporting 'no snoring' or 'slight/occasional' snoring after the procedure, indicating high efficacy.

The procedure was found to be safe, with no serious adverse events reported; minor side effects included partial extrusions and mild transient pain, confirming it as a minimally invasive and relatively painless option for snoring treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Soft palate implants: a new option for treating habitual snoring. Kühnel, TS., Hein, G., Hohenhorst, W., et al.[2018]

The article highlights the need for better guidance for general dental practitioners in managing patients with snoring and obstructive sleep apnea, as current documentation is insufficient.

It discusses the use of a silicone material to enhance the durability of a recognized dental prosthesis, potentially improving treatment outcomes for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dental appliances for snoring and obstructive sleep apnoea: construction aspects for general dental practitioners. Ellis, SG., Craik, NW., Deans, RF., et al.[2018]

In a study of 166 patients using mandibular advancement splints (MAS) for snoring and obstructive sleep apnea, 76% responded to a questionnaire, revealing that 55% continued regular use, with 37% using it every night.

Despite a high satisfaction rate (97% of current users found it effective), many stopped using the splint due to discomfort (52% of nonusers) and perceived lack of efficacy, indicating that while MAS can be effective, long-term compliance may be challenging.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term use of mandibular advancement splints for snoring and obstructive sleep apnoea: a questionnaire survey. McGown, AD., Makker, HK., Battagel, JM., et al.[2019]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9498537/

The Impact of Mouth-Taping in Mouth-Breathers with Mild ... Mouth-taping during sleep improved snoring and the severity of sleep apnea in mouth-breathers with mild OSA, with AHI and SI being reduced by about half.

2. sleepfoundation.org sleepfoundation.org/snoring/mouth-taping-for-sleep

Mouth Taping for Sleep: Does It Work? While research on mouth taping is still limited, some small studies suggest that it may reduce snoring and daytime fatigue in people with mild ...

3. trialfinder.panfoundation.org trialfinder.panfoundation.org/en-US/trial/listing/548955

Study to Examine the Effect of Silicone Mouth Tape ... Recent studies have shown that covering the mouth during sleep with adhesive patches or tape can improve snoring volume without adverse effects.

4. health.clevelandclinic.org health.clevelandclinic.org/mouth-taping

Is Mouth Tape Safe To Use While Sleeping? Mouth taping may seem promising, but it can actually cause more harm than good, especially if you snore or have sleep apnea.

5. news.cuanschutz.edu news.cuanschutz.edu/news-stories/mouth-tape-for-better-sleep-myth-or-miracle

Mouth Tape for Better Sleep: Myth or Miracle? “The evidence we have for mouth taping isn't high quality, and there are mixed results,” said Jessica Camacho, MD, assistant professor of ...

6. sleepapnea.org sleepapnea.org/snoring/mouth-taping-for-sleep/

Mouth Taping for Sleep: Does It Work? - Snoring While some people use it without problems, experts caution that there isn't enough research to confirm its effectiveness or long-term safety.

7. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06587256/study-to-examine-the-effect-of-silicone-mouth-tape-on-snoring-and-mild-sleep-apnea

Study to Examine the Effect of Silicone Mouth Tape ... Data from a home sleep apnea testing device equipped with a snoring microphone found that loud sustained snoring predicted daytime ...

8. journals.plos.org journals.plos.org/plosone/article?id=10.1371/journal.pone.0323643

A systematic review | PLOS One Social media has contributed to a potentially unsafe trend of nighttime mouth taping for individuals with mouth breathing, sleep disordered breathing, or sleep ...

9. withpower.com withpower.com/trial/phase-2-sleep-apnea-syndromes-9-2024-a466c

Mouth Tape for Snoring and Sleep Apnea (MTASSA Trial) Is mouth tape for snoring and sleep apnea safe for humans? There is no specific safety data available for mouth tape, but similar treatments like soft ...