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

• 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: Philips Respironics
• 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

Participant Flow

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
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

Baseline Characteristics

Arm/Group Title		Snorers	Bed Partners	Total
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
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.

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

This includes all bed partners that completed the subjective feedback survey.

Arm/Group Title	Nasal Dilator	Mandibular Advancement	Positional Therapy
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)

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
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

Outcome Measure Data

Analysis Population Description

All snorers were included in the analysis

Arm/Group Title	Nasal Dilator	Mandibular Advancement	Positional Therapy
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
Description	likeliness to recommend purchase (0 to 10 scale). 0 is the worst, 10 is the best.
Time Frame	5 weeks

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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

Adverse Events

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
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%)
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%)
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

Limitations and Caveats

[Not Specified]

More Information

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
• EMail: Noah.Papas@philips.com

• Responsible Party: Philips Respironics
• ClinicalTrials.gov Identifier: NCT03333876
• 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