An interventional study of Nasal Dilator and Mandibular Advancement in Snoring, sponsored by Philips Respironics. Completed at 1 site in United States. Open to participants aged 21 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-02-15.
Sponsored by Philips Respironics (part of Philips) · Not applicable, Interventional, and Treatment
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."
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.
122 studies on the registry are indexed under Snoring; 15 are open to participants now.
This study's enrollment of 58 is above the median of 43 across 95 interventional studies indexed under Snoring.
Browse Snoring studies →Philips Respironics is the lead sponsor of 40 studies on the registry; none are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 14 (100%) have results posted.
First submitted after Philips Respironics became part of Philips.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria (Snorer):
Exclusion Criteria (Snorer):
Have one or more of the following dental issues (by self-report)
Inclusion Criteria (Bed Partner):
Exclusion Criteria (Bed Partner):
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Nasal dilators have been used to treat snoring and sleep apnea. Many studies focus on external nasal dilators like Breathe Right Strips. These interventions largely were not effective in treating OSA. However, there is some evidence to suggest internal to the nose dilators (like Mute) may work to reduce snoring
Device: Nasal Dilator
Mandibular advancement devices have shown to be effective, but not necessarily acceptable to primary snorers.
Device: Mandibular Advancement
Studies have shown mixed results for positional therapy as a whole. Braver and Block reported that foam wedges used to keep patients in a lateral position were not effective in reducing snoring in 20 individuals.
Device: Positional Therapy
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/.
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.
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.
Bed Partners' Rating of Sleep Disturbance Due to Partner Snoring
Bed partner subjective feedback based upon a 0 to 10 scale of "how much did your partner's snoring disturb your sleep last night." 0 was the worst, 10 was the best. This is was evaluated at the end of each period.
Time frame: 5 weeks
Users Acceptance of Each Solution
A star rating based on a 1 -5 scale, overall customer satisfaction with the product (0 to 10 scale), likeliness to buy the product (0 to 10 scale), likeliness to recommend purchase (0 to 10 scale). For the Star rating 1 is the worst, 5 is the best. For the 0 to 10 scale, 0 is the worst, 10 is the best. This was the average acceptance of all users.
Time frame: 5 weeks
Understand User Acceptance of the Bed Partner of Each Solution
likeliness to recommend purchase (0 to 10 scale). 0 is the worst, 10 is the best.
Time frame: 5 weeks
Overall Satisfaction of the Bed Partner of Each Solution
Overall Satisfaction of the Solution from the bed partner (0 to 10 scale). 0 is the worst, 10 is the best.
Time frame: 5 weeks
Total Number of Audio Recordings
Total number of Audio recordings of snoring in different individuals in a baseline setting and using various anti-snoring solutions.
Time frame: Baseline and 5 weeks
58 participants at one site were consented in October 2017 in Pittsburgh, Pennsylvania. 29 were snorers, 29 were bed partners.
| Milestone | All Study Participants |
|---|---|
| Started | 58 |
| Completed | 54 |
| Not completed | 4 |
| Withdrew: Screen failure | 4 |
| Milestone | All Study Participants |
|---|---|
| Started | 54 |
| Completed | 48 |
| Not completed | 6 |
| Withdrew: Bed partner lost to follow up | 6 |
| Milestone | All Study Participants |
|---|---|
| Started | 54 |
| Completed | 50 |
| Not completed | 4 |
| Withdrew: Adverse event | 2 |
| Withdrew: Product damage | 2 |
| Milestone | All Study Participants |
|---|---|
| Started | 54 |
| Completed | 54 |
| Not completed | 0 |
Bed partner subjective feedback based upon a 0 to 10 scale of "how much did your partner's snoring disturb your sleep last night." 0 was the worst, 10 was the best. This is was evaluated at the end of each period.
| units on a scale | Nasal Dilator | Mandibular Advancement | Positional Therapy |
|---|---|---|---|
| Bed Partners' Rating of Sleep Disturbance Due to Partner Snoring | 5.0 ± 1.6 | 3.8 ± 2.2 | 4.4 ± 2.5 |
A star rating based on a 1 -5 scale, overall customer satisfaction with the product (0 to 10 scale), likeliness to buy the product (0 to 10 scale), likeliness to recommend purchase (0 to 10 scale). For the Star rating 1 is the worst, 5 is the best. For the 0 to 10 scale, 0 is the worst, 10 is the best. This was the average acceptance of all users.
| units on a scale | Nasal Dilator | Mandibular Advancement | Positional Therapy |
|---|---|---|---|
| Star Rating | 3.4 ± 0.9 | 2.7 ± 1.2 | 3.1 ± 1.1 |
| overall customer satisfaction with the product | 6.3 ± 1.8 | 4.4 ± 3.3 | 5.5 ± 2.4 |
| likeliness to buy the product | 6.4 ± 2.7 | 4.1 ± 3.6 | 5.3 ± 3.1 |
likeliness to recommend purchase (0 to 10 scale). 0 is the worst, 10 is the best.
| units on a scale | Nasal Dilator | Mandibular Advancement | Positional Therapy |
|---|---|---|---|
| Understand User Acceptance of the Bed Partner of Each Solution | 4.4 ± 3.2 | 4.6 ± 4.0 | 5.4 ± 3.4 |
Overall Satisfaction of the Solution from the bed partner (0 to 10 scale). 0 is the worst, 10 is the best.
| units on a scale | Nasal Dilator | Mandibular Advancement | Positional Therapy |
|---|---|---|---|
| Overall Satisfaction of the Bed Partner of Each Solution | 5.0 ± 3.3 | 5.3 ± 3.6 | 6.6 ± 2.7 |
Total number of Audio recordings of snoring in different individuals in a baseline setting and using various anti-snoring solutions.
| audio recordings | Baseline | Nasal Dilator | Mandibular Advancement | Positional Therapy |
|---|---|---|---|---|
| Total Number of Audio Recordings | 113 | 168 | 328 | 308 |
Collected over All adverse events were collected over a 5 week period on the snorer as the snorer was trying different devices.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Nasal Dilator | 0/27 (0%) | 0/27 (0%) | 0/27 (0%) |
| Mandibular Advancement | 0/27 (0%) | 0/27 (0%) | 3/27 (11.1%) |
| Positional Therapy | 0/27 (0%) | 0/27 (0%) | 0/27 (0%) |
| Event | Nasal Dilator | Mandibular Advancement | Positional Therapy |
|---|---|---|---|
| Jaw PainMusculoskeletal and connective tissue disorders | 0/27 | 3/27 | 0/27 |
This is all participants that were consented and eligible to participant in the study, all baseline demographics include snorer and bed partner with the exception of neck circumference and Body Mass Index (BMI).
| Age, Categorical(Participants) | Snorers | Bed Partners | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 29 | 29 | 58 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Snorers | Bed Partners | Total |
|---|---|---|---|
| Mean | 43.6 ± 7.5 | 43.8 ± 8.3 | 43.7 ± 8.0 |
| Sex: Female, Male(Participants) | Snorers | Bed Partners | Total |
|---|---|---|---|
| Female | 9 | 16 | 25 |
| Male | 20 | 13 | 33 |
| Ethnicity (NIH/OMB)(Participants) | Snorers | Bed Partners | Total |
|---|---|---|---|
| Hispanic or Latino | 1 | 1 | 2 |
| Not Hispanic or Latino | 28 | 28 | 56 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Snorers | Bed Partners | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 3 | 5 | 8 |
| White | 23 | 24 | 47 |
| More than one race | 2 | 0 | 2 |
| Unknown or Not Reported | 1 | 0 | 1 |
| Region of Enrollment(participants) | Snorers | Bed Partners | Total |
|---|---|---|---|
| United States | 29 | 29 | 58 |
| Body Mass Index (BMI)(kg/m^2) | Snorers | Bed Partners | Total |
|---|---|---|---|
| Mean | 31.1 ± 6.5 | — | 31.1 ± 6.5 |
| Neck Circumference(inches) | Snorers | Bed Partners | Total |
|---|---|---|---|
| Mean | 16 ± 1.5 | — | 16 ± 1.5 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — Coded data will be shared with the Philips Research in the Netherlands.
Supporting information: Study protocol, Informed consent form
Time frame: At close of the data collection period that data will be available for analysis. The coded data will be available indefinitely
Access criteria: Those that have access will be trained to Philips procedures.
This study is completed, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.
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