SnoringNCT03333876
In Home Assessment of Three Anti-Snoring Devices, a Cross Over Study
A study testing Nasal Dilator, Mandibular Advancement and Positional Therapy in people with Snoring, run by Philips Respironics at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Snoring
- What is being tested?
- Nasal Dilator, Mandibular Advancement and Positional Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Oct 2017to 3 Dec 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults aged 21 to 55
- Able and willing to provide written informed consent
- Able to read and understand English
- History of snoring for more than 6 months (by self-report).
- Sleep with a bed partner for at least 4 nights per week (by self-report).
- Told by bed partner that snoring frequently disturbs his or her sleep (by self-report).
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- Have seen a dentist within 12 months (by self-report).
- Willing to not use any anti-snoring aids that are not associated with the study (by self-report).
- Has purchased or used or bed partner has purchased an anti-snoring product in the past (by self-report) [These individuals may be included in the study if recruitment timeline dictates it]
- Adults aged 21 to 70
- Able and willing to provide written informed consent
- Able to read and understand English
- Rates sleep disturbance caused by partner's snoring greater than or equal to 4 on a scale of 1-10
- Rates level of snoring volume greater than or equal to 7 on a scale of 1-10
- Willing to sleep in same room as snorer during the study period (by self -report).
- Willing to not start any new over-the-counter or prescription sleep medication including sedatives and hypnotics during the study period (by self-report).
Who cannot join
- 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)
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- 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)
- Removable dentures or bridges.
- Temporary crowns, loose teeth, loose crowns, loose fillings, or broken teeth
- Less than 8 natural, healthy teeth in each dental arch (upper and lower teeth)
- Dental braces
- TemporoMandibular Joint (TMJ) issues
- Told by bed partner that their snoring frequently disturbs his or her sleep (by self-report).
Trial locations and contacts
1 site in 1 country.
United States1 site
Philips Respironics
Murrysville, Pennsylvania, 15668
About this study
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."
Read the 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
- Being tested
- Nasal Dilator, Mandibular Advancement, Positional Therapy
- Medical subject headings
- Snoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nasal DilatorDevice
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/.
Mandibular AdvancementDevice
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 TherapyDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: Nasal Dilator |
| Mandibular Advancement | Active comparator | Mandibular advancement devices have shown to be effective, but not necessarily acceptable to primary snorers. Receives: Device: Mandibular Advancement |
| 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. Receives: Device: Positional Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 weeks
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2017
- Study start9 Oct 2017
- Primary completion3 Dec 2017
- Study completion3 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for SnoringStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Philips Respironics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03333876
- Sponsor's protocol ID
- SRC-AI-SilentNight-10090
- Status last verified
- Feb 2019
- First submitted
- 30 Oct 2017
- Last updated
- 15 Feb 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Coded data will be shared with the Philips Research in the Netherlands.
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In Home Assessment of Three Anti-Snoring Devices, a Cross Over Study
- ClinicalTrials.gov ID
- NCT03333876
- Acronym / sponsor ID
- SRC-AI-SilentNight-10090
- Conditions
- Snoring
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Philips RespironicsIndustry (pharma, biotech, devices)
- Study start
- 9 Oct 2017 (actual)
- Primary completion
- 3 Dec 2017 (actual)
- Study completion
- 3 Dec 2017 (actual)
- First posted
- 7 Nov 2017 (actual)
- Results
- Posted 15 Feb 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Nasal Dilator | Active comparator | Device: Nasal DilatorNasal 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 | Device: Mandibular AdvancementMandibular advancement devices have shown to be effective, but not necessarily acceptable to primary snorers. |
| Positional Therapy | Active comparator | Device: Positional TherapyStudies 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. |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Adults aged 21 to 55
- Able and willing to provide written informed consent
- Able to read and understand English
- History of snoring for more than 6 months (by self-report).
- Sleep with a bed partner for at least 4 nights per week (by self-report).
Key exclusion criteria (17 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nasal DilatorMute 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 | Nasal Dilator |
| Mandibular AdvancementFor 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 | Mandibular Advancement |
| Positional TherapySleep 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. | Device | Positional Therapy |
Primary outcome
Bed Partners' Rating of Sleep Disturbance Due to Partner Snoring
Time frame: 5 weeks
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.
4 secondary outcomes
Users Acceptance of Each Solution
Time frame: 5 weeks
Understand User Acceptance of the Bed Partner of Each Solution
Time frame: 5 weeks
Overall Satisfaction of the Bed Partner of Each Solution
Time frame: 5 weeks
Total Number of Audio Recordings
Time frame: Baseline and 5 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Coded data will be shared with the Philips Research in the Netherlands.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nasal Dilator, Mandibular Advancement and Positional Therapy in people with Snoring, run by Philips Respironics at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Feb 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bed Partners' Rating of Sleep Disturbance Due to Partner Snoring (time frame: 5 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2019.