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

Primary Purpose

Snoring

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Nasal Dilator
Mandibular Advancement
Positional Therapy
Sponsored by
Philips Respironics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Snoring

Eligibility Criteria

21 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria (Snorer):

  • 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).
  • 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]

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)

    • 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

Inclusion Criteria (Bed Partner):

  • 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).

Exclusion Criteria (Bed Partner):

• Told by bed partner that their snoring frequently disturbs his or her sleep (by self-report).

Sites / Locations

  • Philips Respironics

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Nasal Dilator

Mandibular Advancement

Positional Therapy

Arm Description

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 devices have shown to be effective, but not necessarily acceptable to primary snorers.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.

Full Information

First Posted
October 30, 2017
Last Updated
February 8, 2019
Sponsor
Philips Respironics
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1. Study Identification

Unique Protocol Identification Number
NCT03333876
Brief Title
In Home Assessment of Three Anti-Snoring Devices, a Cross Over Study
Official Title
In Home Assessment of Three Anti-Snoring Devices, a Cross Over Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
October 9, 2017 (Actual)
Primary Completion Date
December 3, 2017 (Actual)
Study Completion Date
December 3, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Philips Respironics

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Snoring

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
58 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nasal Dilator
Arm Type
Active Comparator
Arm Description
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
Arm Title
Mandibular Advancement
Arm Type
Active Comparator
Arm Description
Mandibular advancement devices have shown to be effective, but not necessarily acceptable to primary snorers.
Arm Title
Positional Therapy
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Nasal Dilator
Intervention Description
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/.
Intervention Type
Device
Intervention Name(s)
Mandibular Advancement
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Positional Therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Bed Partners' Rating of Sleep Disturbance Due to Partner Snoring
Description
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
Secondary Outcome Measure Information:
Title
Users Acceptance of Each Solution
Description
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
Title
Understand User Acceptance of the Bed Partner of Each Solution
Description
likeliness to recommend purchase (0 to 10 scale). 0 is the worst, 10 is the best.
Time Frame
5 weeks
Title
Overall Satisfaction of the Bed Partner of Each Solution
Description
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
Title
Total Number of Audio Recordings
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria (Snorer): 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). 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] 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) 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 Inclusion Criteria (Bed Partner): 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). Exclusion Criteria (Bed Partner): • Told by bed partner that their snoring frequently disturbs his or her sleep (by self-report).
Facility Information:
Facility Name
Philips Respironics
City
Murrysville
State/Province
Pennsylvania
ZIP/Postal Code
15668
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Coded data will be shared with the Philips Research in the Netherlands.
IPD Sharing Time Frame
At close of the data collection period that data will be available for analysis. The coded data will be available indefinitely
IPD Sharing Access Criteria
Those that have access will be trained to Philips procedures.

Learn more about this trial

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

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