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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nasal Dilator | Active Comparator | 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 |
|
| Mandibular Advancement | Active Comparator | Mandibular advancement devices have shown to be effective, but not necessarily acceptable to primary snorers. |
|
| Positional Therapy | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nasal Dilator | Device | 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/. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 5 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 5 weeks |
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Inclusion Criteria (Snorer):
Exclusion Criteria (Snorer):
Scored higher than a 9 on the Modified Snore Scale Score (MSSS>9)
Scored higher than a 6 on the OSA 50 screener (OSA50>6)
The presence of physical or mental limitations that would limit the ability to use the anti-snoring solutions.
Any unstable medical condition like congestive heart failure, neuromuscular disease, renal failure, or cancer (as determined by self-report and reviewed by the study PI).
Any severe respiratory condition (like an exacerbation of Chronic Obstructive Pulmonary Disease, bronchitis, sinusitis, respiratory failure or insufficiency or patients requiring oxygen therapy).
Known history of Obstructive Sleep Apnea (OSA) or Central Sleep Apnea Syndrome (by self-report)
Only able to sleep in the supine (flat on one's back) position (by self-report).
Actively suffering from an upper respiratory infection (by self-report).
Have a planned medical or dental procedure involving the head, neck, face (eyes, ears, nose, teeth, mouth), or lungs during the trial period (by self-report).
Under active treatment for an active dental problem by a dentist or orthodontist
Have one or more of the following dental issues (by self-report)
Inclusion Criteria (Bed Partner):
Exclusion Criteria (Bed Partner):
• Told by bed partner that their snoring frequently disturbs his or her sleep (by self-report).
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Philips Respironics | Murrysville | Pennsylvania | 15668 | United States |
Coded data will be shared with the Philips Research in the Netherlands.
At close of the data collection period that data will be available for analysis. The coded data will be available indefinitely
Those that have access will be trained to Philips procedures.
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Of the 29 couples, 2 participants screened out. Therefore 27 participants started the study.
58 participants at one site were consented in October 2017 in Pittsburgh, Pennsylvania. 29 were snorers, 29 were bed partners.
| ID | Title | Description |
|---|---|---|
| FG000 | All Study Participants | All study participants that consented are included in the participant flow. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Screening Period |
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| Nasal Dilator |
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| Mandibular Advancement |
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| Positional Therapy |
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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).
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| ID | Title | Description |
|---|---|---|
| BG000 | Snorers | All participants that entered the study that were considered snorers. |
| BG001 | Bed Partners | All participants that entered the study that were considered bed partners. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | This includes all bed partners that completed the subjective feedback survey. | Posted | Mean | Standard Deviation | units on a scale | 5 weeks |
|
All adverse events were collected over a 5 week period on the snorer as the snorer was trying different devices.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Nasal Dilator | 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. 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/. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Jaw Pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | 3 participants complained of Jaw Pain/Discomfort/Popping |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Noah Papas | Philips Respironics | 4122776436 | Noah.Papas@philips.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 14, 2017 | Nov 12, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D012913 | Snoring |
| ID | Term |
|---|---|
| D012135 | Respiratory Sounds |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D019186 | Mandibular Advancement |
| ID | Term |
|---|---|
| D019647 | Oral Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D003813 | Dentistry |
| D009970 | Orthodontics |
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|
| Mandibular Advancement | Device | 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. |
|
| Positional Therapy | Device | 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. |
|
| 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. | 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. | 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. | Baseline and 5 weeks |
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| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Body Mass Index (BMI) | This only includes snorers. As BMI is an important data element for the snoring group. However, provides no value for bed partner. This also excludes the two participants there were found not eligible for the study. | Mean | Standard Deviation | kg/m^2 |
|
| Neck Circumference | This only includes snorers. As Neck Circumference is an important data element for the snoring group. However, provides no value for bed partner. This also excludes the two participants there were found not eligible for the study. | Mean | Standard Deviation | inches |
|
| OG001 | Mandibular Advancement | Mandibular advancement devices have shown to be effective, but not necessarily acceptable to primary snorers. 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. |
| OG002 | Positional Therapy | Positional Therapy was conducted with a 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. |
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|
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| Secondary | 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. | All snorers were included in the analysis | Posted | Mean | Standard Deviation | units on a scale | 5 weeks |
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|
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| Secondary | 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. | All bed partners that completed the final survey were included in the analysis. | Posted | Mean | Standard Deviation | units on a scale | 5 weeks |
|
|
|
| Secondary | 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. | All bed partners that completed the final survey were included in the analysis. Not all bed partners completed the final survey. | Posted | Mean | Standard Deviation | units on a scale | 5 weeks |
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| Secondary | 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. | All participants that entered the study had recordings. This record just includes snorer records, not bed partner. 12 recording could not be counted as they were not classified correctly by participants. Additional baseline nights were recorded by participants because of baseline extension or recordings in between device use. | Posted | Number | audio recordings | Baseline and 5 weeks |
|
|
|
| 0 |
| 27 |
| 0 |
| 27 |
| 0 |
| 27 |
| EG001 | Mandibular Advancement | Mandibular advancement devices have shown to be effective, but not necessarily acceptable to primary snorers. 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. | 0 | 27 | 0 | 27 | 3 | 27 |
| EG002 | Positional Therapy | 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. 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. | 0 | 27 | 0 | 27 | 0 | 27 |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
|
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| likeliness to buy the product |
|