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

Trial Summary

What is the purpose of this trial?

Snoring is a common problem caused by vibration of tissues in the throat region during sleep. Although snoring is sometimes dismissed as a minor nuisance rather than a medical disorder, several studies indicate that snoring can disrupt sleep quality of the snorer, as well as the snorer's bed partner. Snoring also might lead to problems such as dry mouth, bad breath, dental problems, and even cardiovascular disease. Current treatments for snoring include lifestyle modifications such as weight loss, side-sleeping, and avoidance of evening alcohol intake. In some cases, invasive surgeries, dental devices, or even CPAP are recommended for snoring. These interventions have mixed effectiveness and may be difficult to use. It may be possible to treat snoring by fostering nasal breathing, while avoiding mouth-breathing during sleep. Breathing through the mouth reduces the airway diameter and contributes to snoring. Several studies show that nasal breathing can reduce snoring volume and improve airflow. Recent studies have shown that covering the mouth during sleep with adhesive patches or tape can improve snoring volume without adverse effects. However, these studies were performed in a small number of patients and did not fully measure the impact of the intervention on sleep quality, sleep architecture, or the experience of the bed partner, who is often the overlooked "victim" of the snoring. In this interventional study, the investigators will examine the safety and efficacy of mouth tape for snoring, focusing on subjective and objective snoring/breathing metrics of both the snorer and bed partner. Snoring is sometimes also a sign of obstructive sleep apnea (OSA). If OSA is ruled out with a sleep study, patients are considered to have "simple" snoring. When OSA is mild (apnea hypopnea index 15), treatments can include the same interventions as snoring (e.g. weight loss, avoidance of alcohol, side-sleeping) or can be more aggressively treated with devices such as continuous positive airway pressure (CPAP). CPAP may be challenging to use, expensive, and associated with side effects such as mouth dryness and skin irritation. Alternative, inexpensive, and well-tolerated interventions are needed for mild OSA. For this reason, the investigators include patients with snoring and mild OSA in this study.

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 data supports the effectiveness of the treatment for snoring and sleep apnea?

Research on similar treatments, like mandibular advancement splints, shows they can reduce snoring and improve sleep apnea by keeping the airway open. This suggests that mouth tape, which also aims to keep the mouth closed and airway clear, might have similar benefits. ^{1 2 3 4 5}

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 palate implants and mandibular advancement devices have been shown to be generally safe with some minor side effects such as mild pain or dental changes. ^{6 7 8 9 10}

How is the Mouth Tape treatment for snoring and sleep apnea different from other treatments?

The Mouth Tape treatment is unique because it involves using a silicone adhesive patch to keep the mouth closed during sleep, which can help reduce mouth breathing and improve airflow. This approach is different from other treatments like oral appliances that reposition the jaw or tongue, as it focuses on promoting nasal breathing by physically sealing the lips. ^{2 4 11 12 13}

Research Team

Jonathan Jun, MD

Principal Investigator

Johns Hopkins University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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]

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]

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]

References

1. Germany 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]. [2009]

2. England pubmed.ncbi.nlm.nih.gov

Does an oral appliance reduce palatal flutter and tongue base snoring? [2007]

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

Mandibular advancement splint: an appliance to treat snoring and obstructive sleep apnea. [2015]

4. England pubmed.ncbi.nlm.nih.gov

Dental appliances for snoring and obstructive sleep apnoea: construction aspects for general dental practitioners. [2018]

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

Long-term use of mandibular advancement splints for snoring and obstructive sleep apnoea: a questionnaire survey. [2019]

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

A new tongue advancement technique for sleep-disordered breathing: side effects and efficacy. [2007]

7. England pubmed.ncbi.nlm.nih.gov

Treating obstructive sleep apnea and snoring: assessment of an anterior mandibular positioning device. [2019]

8. England pubmed.ncbi.nlm.nih.gov

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

9. Germany pubmed.ncbi.nlm.nih.gov

Dental side effects of mandibular advancement appliances - a 2-year follow-up. [2016]

10. Germany pubmed.ncbi.nlm.nih.gov

Soft palate implants: a new option for treating habitual snoring. [2018]

11. South Africa pubmed.ncbi.nlm.nih.gov

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

12. England pubmed.ncbi.nlm.nih.gov

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

13. Switzerland pubmed.ncbi.nlm.nih.gov

The Impact of Mouth-Taping in Mouth-Breathers with Mild Obstructive Sleep Apnea: A Preliminary Study. [2022]