Trial Outcomes & Findings for In Home Assessment of Three Anti-Snoring Devices, a Cross Over Study (NCT NCT03333876)

Last Updated: 2019-02-15

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

58 participants

Primary outcome timeframe

5 weeks

Results posted on

2019-02-15

Participant Flow

58 participants at one site were consented in October 2017 in Pittsburgh, Pennsylvania. 29 were snorers, 29 were bed partners.

Of the 29 couples, 2 participants screened out. Therefore 27 participants started the study.

Unit of analysis: partners

Participant milestones

Participant milestones
Measure	All Study Participants All study participants that consented are included in the participant flow.
Screening Period STARTED	58 29
Screening Period COMPLETED	54 27
Screening Period NOT COMPLETED	4 2
Nasal Dilator STARTED	54 27
Nasal Dilator COMPLETED	48 24
Nasal Dilator NOT COMPLETED	6 3
Mandibular Advancement STARTED	54 27
Mandibular Advancement COMPLETED	50 25
Mandibular Advancement NOT COMPLETED	4 2
Positional Therapy STARTED	54 27
Positional Therapy COMPLETED	54 27
Positional Therapy NOT COMPLETED	0 0

Reasons for withdrawal

Reasons for withdrawal
Measure	All Study Participants All study participants that consented are included in the participant flow.
Screening Period Screen Failure	4
Nasal Dilator Bed Partner Lost to follow up	6
Mandibular Advancement Adverse Event	2
Mandibular Advancement Product Damage	2

Baseline Characteristics

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.

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: 5 weeks

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

Outcome measures

Outcome measures
Measure	Nasal Dilator n=24 Participants 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 n=25 Participants 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 n=27 Participants 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.	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.
Bed Partners' Rating of Sleep Disturbance Due to Partner Snoring	5.0 units on a scale Standard Deviation 1.6	3.8 units on a scale Standard Deviation 2.2	4.4 units on a scale Standard Deviation 2.5	—

SECONDARY outcome

Timeframe: 5 weeks

Population: All snorers were included in the analysis

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.

Outcome measures

Outcome measures
Measure	Nasal Dilator n=27 Participants 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 n=27 Participants 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 n=27 Participants 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.	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.
Users Acceptance of Each Solution Star Rating	3.4 units on a scale Standard Deviation 0.9	2.7 units on a scale Standard Deviation 1.2	3.1 units on a scale Standard Deviation 1.1	—
Users Acceptance of Each Solution overall customer satisfaction with the product	6.3 units on a scale Standard Deviation 1.8	4.4 units on a scale Standard Deviation 3.3	5.5 units on a scale Standard Deviation 2.4	—
Users Acceptance of Each Solution likeliness to buy the product	6.4 units on a scale Standard Deviation 2.7	4.1 units on a scale Standard Deviation 3.6	5.3 units on a scale Standard Deviation 3.1	—

SECONDARY outcome

Timeframe: 5 weeks

Population: All bed partners that completed the final survey were included in the analysis.

likeliness to recommend purchase (0 to 10 scale). 0 is the worst, 10 is the best.

Outcome measures

Outcome measures
Measure	Nasal Dilator n=25 Participants 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 n=26 Participants 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 n=27 Participants 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.	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.
Understand User Acceptance of the Bed Partner of Each Solution	4.4 units on a scale Standard Deviation 3.2	4.6 units on a scale Standard Deviation 4.0	5.4 units on a scale Standard Deviation 3.4	—

SECONDARY outcome

Timeframe: 5 weeks

Population: All bed partners that completed the final survey were included in the analysis. Not all bed partners completed the final survey.

Overall Satisfaction of the Solution from the bed partner (0 to 10 scale). 0 is the worst, 10 is the best.

Outcome measures

Outcome measures
Measure	Nasal Dilator n=24 Participants 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 n=26 Participants 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 n=27 Participants 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.	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.
Overall Satisfaction of the Bed Partner of Each Solution	5.0 units on a scale Standard Deviation 3.3	5.3 units on a scale Standard Deviation 3.6	6.6 units on a scale Standard Deviation 2.7	—

SECONDARY outcome

Timeframe: Baseline and 5 weeks

Population: 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.

Total number of Audio recordings of snoring in different individuals in a baseline setting and using various anti-snoring solutions.

Outcome measures

Outcome measures
Measure	Nasal Dilator n=27 Participants 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 n=24 Participants 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 n=26 Participants 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.	Positional Therapy n=27 Participants 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.
Total Number of Audio Recordings	113 audio recordings	168 audio recordings	328 audio recordings	308 audio recordings

Adverse Events

Nasal Dilator

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Mandibular Advancement

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Positional Therapy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Nasal Dilator n=27 participants at risk 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 n=27 participants at risk 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 n=27 participants at risk 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.
Musculoskeletal and connective tissue disorders Jaw Pain	0.00% 0/27 • All adverse events were collected over a 5 week period on the snorer as the snorer was trying different devices.	11.1% 3/27 • Number of events 3 • All adverse events were collected over a 5 week period on the snorer as the snorer was trying different devices.	0.00% 0/27 • All adverse events were collected over a 5 week period on the snorer as the snorer was trying different devices.

Additional Information

Noah Papas

Philips Respironics

Phone: 4122776436

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Snorers n=29 Participants All participants that entered the study that were considered snorers.	Bed Partners n=29 Participants All participants that entered the study that were considered bed partners.	Total n=58 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=29 Participants	0 Participants n=29 Participants	0 Participants n=58 Participants
Age, Categorical Between 18 and 65 years	29 Participants n=29 Participants	29 Participants n=29 Participants	58 Participants n=58 Participants
Age, Categorical >=65 years	0 Participants n=29 Participants	0 Participants n=29 Participants	0 Participants n=58 Participants
Age, Continuous	43.6 years STANDARD_DEVIATION 7.5 • n=29 Participants	43.8 years STANDARD_DEVIATION 8.3 • n=29 Participants	43.7 years STANDARD_DEVIATION 8.0 • n=58 Participants
Sex: Female, Male Female	9 Participants n=29 Participants	16 Participants n=29 Participants	25 Participants n=58 Participants
Sex: Female, Male Male	20 Participants n=29 Participants	13 Participants n=29 Participants	33 Participants n=58 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=29 Participants	1 Participants n=29 Participants	2 Participants n=58 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	28 Participants n=29 Participants	28 Participants n=29 Participants	56 Participants n=58 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=29 Participants	0 Participants n=29 Participants	0 Participants n=58 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=29 Participants	0 Participants n=29 Participants	0 Participants n=58 Participants
Race (NIH/OMB) Asian	0 Participants n=29 Participants	0 Participants n=29 Participants	0 Participants n=58 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=29 Participants	0 Participants n=29 Participants	0 Participants n=58 Participants
Race (NIH/OMB) Black or African American	3 Participants n=29 Participants	5 Participants n=29 Participants	8 Participants n=58 Participants
Race (NIH/OMB) White	23 Participants n=29 Participants	24 Participants n=29 Participants	47 Participants n=58 Participants
Race (NIH/OMB) More than one race	2 Participants n=29 Participants	0 Participants n=29 Participants	2 Participants n=58 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=29 Participants	0 Participants n=29 Participants	1 Participants n=58 Participants
Region of Enrollment United States	29 participants n=29 Participants	29 participants n=29 Participants	58 participants n=58 Participants
Body Mass Index (BMI)	31.1 kg/m^2 STANDARD_DEVIATION 6.5 • n=27 Participants • 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.	—	31.1 kg/m^2 STANDARD_DEVIATION 6.5 • n=27 Participants • 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	16 inches STANDARD_DEVIATION 1.5 • n=29 Participants • 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.	—	16 inches STANDARD_DEVIATION 1.5 • n=29 Participants • 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.