NCT03333876

In Home Assessment of Three Anti-Snoring Devices, a Cross Over Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 58 (actual)
• Sponsor: Philips Respironics · Industry
• Sex: All
• Age: 21 Years – 70 Years
• Healthy volunteers: Accepted

Summary

Silent Night is a solution for primary snorers to guide them to the proper anti-snoring solution. It consists of a mobile application, which had an intake questionnaire, guides users to one of three anti-snoring solutions; a nasal dilator called, Mute (Rhinomed, Australia), a mandibular advancement device called myTAP V (Airway Management, Austin, TX) and a Sleep Positional Trainer SPT (SPT) (NightBalance, Netherlands). The Silent Night app also records snoring through the night and provides feedback to the user via a "snore score."

Detailed description

Silent Night is a solution for primary snorers to guide them to the proper anti-snoring solution. It consists of a mobile application, which had an intake questionnaire, guides users to one of three anti-snoring solutions; a nasal dilator called, Mute (Rhinomed, Australia), a mandibular advancement device called myTAP V (Airway Management, Austin, TX) and a Sleep Positional Trainer SPT (SPT) (NightBalance, Netherlands). The Silent Night app also records snoring through the night and provides feedback to the user via a "snore score." The objective of this trial is twofold. First, each of the interventions to be studied are known to be effective for snoring cessation. However, each is not fully effective in the total population. Their effectiveness is predicated on how an individual snores and where the snore anatomically originates. I.e. if someone position ally snores because their tongue moves back in their mouth, it is unlikely a nasal dilator will work for that individual. In order to improve the SilentNight recommendation algorithm more information needs to be gathered. By asking a battery of questions of a snorer, and having them trial all three snoring solutions it may be possible to understand the comparative effectiveness of each solution, the user acceptance of each solution and which questions should be used to discern what solution will work best for a given individual. The second objective is to collect "in the wild" audio of snoring. The goal of this data collection, is to identify unique characteristics in the sound recording. These paired with the answers to the intake questions, and the relative effectiveness of the three anti-snoring solutions could phenotype the snore and snorer. This audio data could also be used to develop or refine a "snore score", a semi-objective assessment of snoring audio. To accomplish these goals, a feasibility, crossover, in home study will be conducted. Up to 30 couples will be recruited to try each of the anti-snoring solutions over an approximately 5 week period. The participant couples will consist of a snorer and a bed partner. The snorer will use the three solutions (1 week for Mute, 2 weeks for myTAP and SPT) and give feedback on the devices, and sleep quality. The bed partner will also provide feedback on their sleep quality, the loudness of snoring and their perception of the device (as a non-user). They will also record bedroom sound during each night of the trial, including a baseline period where no snoring will take place. Each morning the bed partner will rate the snoring severity. The primary endpoint will be the daily rating of snoring severity as rated by the bed partner. The daily responses will be averaged on a weekly basis. Due to titration and acclimation during the first 9 nights of use nights 10-14 of myTAP V and SPT use will be compared to the week of Mute use. If formal statistical comparisons are performed, continuous data will be compared between the three therapies using repeated-measures ANOVA or the non-parametric Friedman Test, depending on the distributions of the endpoints. If an overall significant effect is observed, post-hoc pairwise tests will be done with a suitable adjustment for multiple comparisons. Categorical data will be compared between therapies using the Cochran's Q test.

Conditions

• Snoring

Interventions

Type	Name	Description
DEVICE	Nasal Dilator	Mute is a pair of nasal dilators that fit snugly in the nose of the snorer dilating the nostrils to help reduce or eliminate snoring. This is an over-the-counter (OTC) product and is cleared by FDA for use in the United States. The introduction video for Mute is located at http://mutesnoring.com/how-to-use/.
DEVICE	Mandibular Advancement	For purposes of this trial, we will be using an investigational myTAP V, which is not available for commercial use. The changes from the released product are: a vertical offset (+3mm) has been added to the design of the adjustment post and mechanism to improve overall comfort. myTAPTM is a mandibular advancement device used for snoring relief. The product requires a prescription and is cleared by FDA for use in the United States.
DEVICE	Positional Therapy	Sleep Positional Trainer (SPT) is a small device worn around the chest with an ergonomic band that continuously monitors the sleep position of the snorer. When the snorer is supine, it emits a gentle vibration to remind them to turn to the side to help reduce or eliminate their snoring.

Timeline

• Start date: 2017-10-09
• Primary completion: 2017-12-03
• Completion: 2017-12-03
• First posted: 2017-11-07
• Last updated: 2019-02-15
• Results posted: 2019-02-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study