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

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ClinicalTrials.gov Identifier: NCT03333876
Recruitment Status : Completed
First Posted : November 7, 2017
Results First Posted : February 15, 2019
Last Update Posted : February 15, 2019
Sponsor:
Information provided by (Responsible Party):
Philips Respironics

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Snoring
Interventions Device: Nasal Dilator
Device: Mandibular Advancement
Device: Positional Therapy
Enrollment 58
Recruitment Details 58 participants at one site were consented in October 2017 in Pittsburgh, Pennsylvania. 29 were snorers, 29 were bed partners.
Pre-assignment Details Of the 29 couples, 2 participants screened out. Therefore 27 participants started the study.
Arm/Group Title All Study Participants
Hide Arm/Group Description All study participants that consented are included in the participant flow.
Period Title: Screening Period
Number of participants Number of units (partners)
Started 58 29
Completed 54 27
Not Completed 4 2
Reason Not Completed
Screen Failure             4            
Period Title: Nasal Dilator
Number of participants Number of units (partners)
Started 54 27
Completed 48 24
Not Completed 6 3
Reason Not Completed
Bed Partner Lost to follow up             6            
Period Title: Mandibular Advancement
Number of participants Number of units (partners)
Started 54 27
Completed 50 25
Not Completed 4 2
Reason Not Completed
Adverse Event             2            
Product Damage             2            
Period Title: Positional Therapy
Number of participants Number of units (partners)
Started 54 27
Completed 54 27
Not Completed 0 0
Arm/Group Title Snorers Bed Partners Total
Hide Arm/Group Description All participants that entered the study that were considered snorers. All participants that entered the study that were considered bed partners. Total of all reporting groups
Overall Number of Baseline Participants 29 29 58
Hide Baseline Analysis Population Description
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  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 29 participants 29 participants 58 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
29
 100.0%
29
 100.0%
58
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 29 participants 29 participants 58 participants
43.6  (7.5) 43.8  (8.3) 43.7  (8.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 29 participants 29 participants 58 participants
Female
9
  31.0%
16
  55.2%
25
  43.1%
Male
20
  69.0%
13
  44.8%
33
  56.9%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 29 participants 29 participants 58 participants
Hispanic or Latino
1
   3.4%
1
   3.4%
2
   3.4%
Not Hispanic or Latino
28
  96.6%
28
  96.6%
56
  96.6%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 29 participants 29 participants 58 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
3
  10.3%
5
  17.2%
8
  13.8%
White
23
  79.3%
24
  82.8%
47
  81.0%
More than one race
2
   6.9%
0
   0.0%
2
   3.4%
Unknown or Not Reported
1
   3.4%
0
   0.0%
1
   1.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 29 participants 29 participants 58 participants
29 29 58
Body Mass Index (BMI)   [1] 
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 27 participants 0 participants 27 participants
31.1  (6.5) 31.1  (6.5)
[1]
Measure Analysis Population Description:

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.

Neck Circumference   [1] 
Mean (Standard Deviation)
Unit of measure:  Inches
Number Analyzed 29 participants 0 participants 29 participants
16  (1.5) 16  (1.5)
[1]
Measure Analysis Population Description:

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.

1.Primary Outcome
Title Bed Partners' Rating of Sleep Disturbance Due to Partner Snoring
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
This includes all bed partners that completed the subjective feedback survey.
Arm/Group Title Nasal Dilator Mandibular Advancement Positional Therapy
Hide Arm/Group 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 Obstructive Sleep Apnea (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/.

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.

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.
Overall Number of Participants Analyzed 24 25 27
Mean (Standard Deviation)
Unit of Measure: units on a scale
5.0  (1.6) 3.8  (2.2) 4.4  (2.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Nasal Dilator, Mandibular Advancement, Positional Therapy
Comments Each group was compared to baseline.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.001
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
2.Secondary Outcome
Title Users Acceptance of Each Solution
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
All snorers were included in the analysis
Arm/Group Title Nasal Dilator Mandibular Advancement Positional Therapy
Hide Arm/Group 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.

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/.

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.

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.
Overall Number of Participants Analyzed 27 27 27
Mean (Standard Deviation)
Unit of Measure: units on a scale
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)
3.Secondary Outcome
Title Understand User Acceptance of the Bed Partner of Each Solution
Hide Description likeliness to recommend purchase (0 to 10 scale). 0 is the worst, 10 is the best.
Time Frame 5 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All bed partners that completed the final survey were included in the analysis.
Arm/Group Title Nasal Dilator Mandibular Advancement Positional Therapy
Hide Arm/Group 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.

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/.

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.

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.
Overall Number of Participants Analyzed 25 26 27
Mean (Standard Deviation)
Unit of Measure: units on a scale
4.4  (3.2) 4.6  (4.0) 5.4  (3.4)
4.Secondary Outcome
Title Overall Satisfaction of the Bed Partner of Each Solution
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
All bed partners that completed the final survey were included in the analysis. Not all bed partners completed the final survey.
Arm/Group Title Nasal Dilator Mandibular Advancement Positional Therapy
Hide Arm/Group 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.

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/.

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.

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.
Overall Number of Participants Analyzed 24 26 27
Mean (Standard Deviation)
Unit of Measure: units on a scale
5.0  (3.3) 5.3  (3.6) 6.6  (2.7)
5.Secondary Outcome
Title Total Number of Audio Recordings
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description

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.

Arm/Group Title Baseline Nasal Dilator Mandibular Advancement Positional Therapy
Hide Arm/Group Description:
All participants that entered the study were to complete a baseline period of 3 nights in which no intervention was used, but sleep was recorded.

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/.

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.

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.
Overall Number of Participants Analyzed 27 24 26 27
Measure Type: Number
Unit of Measure: audio recordings
113 168 328 308
Time Frame All adverse events were collected over a 5 week period on the snorer as the snorer was trying different devices.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Nasal Dilator Mandibular Advancement Positional Therapy
Hide Arm/Group 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.

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/.

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.

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.

All-Cause Mortality
Nasal Dilator Mandibular Advancement Positional Therapy
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/27 (0.00%)      0/27 (0.00%)      0/27 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Nasal Dilator Mandibular Advancement Positional Therapy
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/27 (0.00%)      0/27 (0.00%)      0/27 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Nasal Dilator Mandibular Advancement Positional Therapy
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/27 (0.00%)      3/27 (11.11%)      0/27 (0.00%)    
Musculoskeletal and connective tissue disorders       
Jaw Pain * [1]  0/27 (0.00%)  0 3/27 (11.11%)  3 0/27 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
[1]
3 participants complained of Jaw Pain/Discomfort/Popping
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Noah Papas
Organization: Philips Respironics
Phone: 4122776436
Responsible Party: Philips Respironics
ClinicalTrials.gov Identifier: NCT03333876     History of Changes
Other Study ID Numbers: SRC-AI-SilentNight-10090
First Submitted: October 30, 2017
First Posted: November 7, 2017
Results First Submitted: December 11, 2018
Results First Posted: February 15, 2019
Last Update Posted: February 15, 2019