Mouth Tape for Snoring and Sleep Apnea
(MTASSA Trial)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: Johns Hopkins University
Disqualifiers: Chronic lung disease, Pregnancy, others
No Placebo Group
Prior Safety Data
Approved in 1 Jurisdiction
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.
12345Is 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.
678910How 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.
24111213Eligibility 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
+2 more
Trial 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
Participant Groups
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.
1Treatment groups
Experimental Treatment
Group I: Simple snorers or Mild Sleep ApneaExperimental Treatment1 Intervention
Patients with snoring and a prior sleep study showing an AHI \< 15.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Johns Hopkins Bayview Medical CenterBaltimore, MD
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Who Is Running the Clinical Trial?
Johns Hopkins UniversityLead Sponsor
References
[Optical stimulation method (Snore-Stop) and tongue retainer (Snore-Master) without relevance in therapy of obstructive sleep apnea and snoring]. [2009]Recently intra- und extraoral devices are increasingly used in order to treat obstructive sleep apnea and snoring. We examined the value of an optically stimulating system ("eye-cover", Snore-Stop) and a tongue-retainer (Snore-Master) as treatment of the obstructive sleep apnoe or snoring. In case of the eye-cover is a microphone integrated, which detects acoustic signals (e.g. snoring). After detection of snoring optical stimuli are generated in front of the eyes. This is intended to induce an arousal of the patient, without awaking him, causing a change of body position and this reduces the snoring or apneas. For the examination of the eye-cover in 26 patients (23 men, 55.6 +/- 10.3 years) polygraphic studies were performed while sleeping one night with the eye-cover and one night without, respectively. Visual analogue scales (VAS) were used in order to measure quality of life and sleep and the adverse effects of the device. To examine the tongue-retainer 14 patients (13 men, aged 52.9 +/- 11.8 years) were measured polygraphically. Again the subjective scores were assessed using the VAS. The principle of the tongue-retainer is to create a hollow space in front of the teeth, in which the tongue is positioned. Fixation of the tongue in this ventral position is thought to enlarge the mesopharyngeal area in order to reduce the upper airway obstruction. For both devices the index of snoring, the apnea-hypopnea-index, the index of desaturation, the mean and minimal SaO2 and SaO2
Does an oral appliance reduce palatal flutter and tongue base snoring? [2007]Oral appliances are designed to treat snoring and sleep apnea by advancing the mandible and tongue. We test the hypothesis that an oral appliance affects palatal snoring as well as tongue base obstruction.
Mandibular advancement splint: an appliance to treat snoring and obstructive sleep apnea. [2015]Snoring and obstructive sleep apnea (OSA) are related to narrowing of the upper airway. A mandibular advancement splint (MAS) could improve both conditions by increasing oropharyngeal and hypopharyngeal dimensions. The effects of a MAS on snoring and OSA was evaluated 3.5 +/- 2.1 (mean +/- SD) mo after issue in 57 subjects with habitual loud snoring, 39 of whom had an apnea-hypopnea index (AHI) > or = 10. Assessment was by questionnaire (all subjects) and polysomnography (51 subjects, 47 male) including measurement of sound intensity. Use of the MAS was randomized to first or second half of study. Snores were scored where inspiratory noise was greater than 5 dB above background. Total sleep time, sleep efficiency, % REM sleep, and % sleep spent supine were similar (p > 0.05) with and without the MAS. Snores per sleep minute, corrected for time in apnea, and sound intensity of snores (% snores > or = 50 dB) decreased with the MAS from 11.0 +/- 5.8 and 42.0 +/- 25.0% to 9.0 +/- 6.0 (p 60. Forty-five patients continued to use the MAS regularly.(ABSTRACT TRUNCATED AT 250 WORDS)
Dental appliances for snoring and obstructive sleep apnoea: construction aspects for general dental practitioners. [2018]The medical and dental aspects of management for patients diagnosed with snoring and obstructive sleep apnoea are well documented. However, guidance for treatment by the general dental practitioner is lacking. This article reviews aspects of appliance provision and presents the use of a silicone material in an attempt to improve the longevity of a recognized prosthesis.
Long-term use of mandibular advancement splints for snoring and obstructive sleep apnoea: a questionnaire survey. [2019]A mandibular advancement splint (MAS) may be an alternative treatment for snoring and obstructive sleep apnoea (OSA). However, there is little subjective or objective information concerning long-term effectiveness, compliance and side effects. A retrospective questionnaire was used to survey these issues plus patient satisfaction and maintenance requirements in 166 patients who could have worn a mandibular advancement splint for over a year. One-hundred and twenty-six (76%) subjects returned the questionnaire, (84 with OSA, 42 snorers), of whom 69 (55%) reported still using the splint regularly, 47 (37%) every night. The most common reported reasons for stopping use were discomfort (29/ 57; 52%) of nonusers), and poor perceived efficacy (12 subjects). Users reported more daytime symptoms, and they and their partners were more likely to observe improvements with splint use. Side effects were reported by 49 subjects, more commonly in nonusers. Sixty-five of 67 current users and 23 of 41 nonusers reported less snoring with splint use (p =
A new tongue advancement technique for sleep-disordered breathing: side effects and efficacy. [2007]We examined the efficacy and the acceptance of an oral device (SnorEx) causing a forward displacement of the tongue for the treatment of sleep-disordered breathing (SDB). Twenty-three consecutive subjects with SDB were investigated. Noncompliance (NC) of use of the oral appliance was observed in 74% (17 of 23) of the subjects. NC patients were characterized by unacceptable local side effects of the prosthesis, lacking improvement of indicators of daytime well-being, and a missing reduction of the respiratory disturbance index (RDI). The device was tolerated without side effects in 26% (6 of 23) of the subjects. In these compliant (C) subjects the RDI, EDS, and snoring improved significantly (p
Treating obstructive sleep apnea and snoring: assessment of an anterior mandibular positioning device. [2019]Dental devices have been used to help manage snoring and obstructive sleep apnea, or OSA. This article reports on patients' compliance with and complications of long-term use of an anterior mandibular positioning, or AMP, device.
Snoring and the role of the GDP: British Society of Dental Sleep Medicine (BSDSM) pre-treatment screening protocol. [2009]Snoring is not necessarily a benign condition; it can be linked to the serious condition obstructive sleep apnoea (OSA). In some cases mandibular repositioning devices can be an effective treatment for simple snoring and mild to moderate sleep apnoea, and these devices can be provided by dentists (with appropriate training and in line with Dental Protection Ltd guidelines). Until now, the dental profession has not been given any guidance on how to differentiate between patients who may be treated without further reference to medical colleagues (ie simple snorers), and those who should be referred for specialist assessment. The aim of this paper is to facilitate safe treatment of snoring and OSA and to protect dentists by explaining an accepted method for screening patients for obstructive sleep apnoea.
Dental side effects of mandibular advancement appliances - a 2-year follow-up. [2016]Mandibular advancement appliances are employed in treating snoring and various forms of obstructive sleep apnea syndrome (OSAS). The splints facilitate the displacement of the mandible anteriorly and widens the pharyngeal lumen during sleep. Two-splint systems are anchored on the dental arches in the maxilla and mandible. The resulting reciprocal forces are transferred onto the teeth, leading to dental side effects when used long-term. We retrospectively examined the dental changes that occurred after patients had worn the Thornton Adjustable Positioner (TAP) for over two years.
Soft palate implants: a new option for treating habitual snoring. [2018]One hundred six patients with proven habitual snoring were each treated with three implants consisting of a cylindrical-shaped segment of braided polyester filaments (18 mm in length with an outer diameter of 1.5 mm) in the soft palate. The implants, pre-loaded in a single-use delivery tool, were inserted into the soft palate under local anesthesia. Along with the initial examination, follow-up exams were done after the treatment to test the safety and efficacy of the procedure. Snoring post treatment was reported as "no snoring" or "slight/occasional" in the majority of the cases after treatment. The results indicate there were no serious adverse events reported. The most frequent minor adverse events were partial extrusions in which the patient often presented a minor foreign body sensation along with mild transient pain. This data has demonstrated the procedure as a minimally invasive, relatively painless, simple procedure that has been shown to be safe and effective.
Clinical trial of an oral vestibular shield for the control of snoring. [2004]Stock intra-oral vestibular shields of a heat malleable, semiflexible ethylene vinyl-acetate material were adapted at chairside to the mouths of 77 chronic snorers. The effectiveness of the shield in controlling snoring was assessed eight to ten weeks after fitting. 77.9 per cent of subjects benefitted from wearing the device. Of the subjects who failed to benefit nine (11.7 per cent) appeared to have nasal or naso-pharyngeal obstruction. A further five (6.5 per cent) abandoned the clinical trial due to poor self-motivation while two subjects (2.6 per cent) were unable to tolerate the shield in the mouth. The potential of the device in the management of obstructive sleep apnoea warrants further investigation.
Novel porous oral patches for patients with mild obstructive sleep apnea and mouth breathing: a pilot study. [2022]Habitual open-mouth breathing (OMB) during sleep can cause snoring and obstructive sleep apnea (OSA). This study used a porous oral patch (POP) to treat patients with mild OSA and OMB during sleep. The subjective and objective outcomes were evaluated.
The Impact of Mouth-Taping in Mouth-Breathers with Mild Obstructive Sleep Apnea: A Preliminary Study. [2022]Many patients with obstructive sleep apnea (OSA) are mouth-breathers. Mouth-breathing not only narrows the upper airway, consequently worsening the severity of OSA, but also it affects compliance with nasal continuous positive airway pressure (CPAP) treatment. This study aimed to investigate changes in OSA by the use of mouth tape in mouth-breathers with mild OSA.