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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

Tracking Information
First Submitted Date  ICMJE October 30, 2017
First Posted Date  ICMJE November 7, 2017
Results First Submitted Date  ICMJE December 11, 2018
Results First Posted Date  ICMJE February 15, 2019
Last Update Posted Date February 15, 2019
Actual Study Start Date  ICMJE October 9, 2017
Actual Primary Completion Date December 3, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 8, 2019)
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.
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT03333876 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 8, 2019)
  • Users Acceptance of Each Solution [ Time Frame: 5 weeks ]
    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 [ Time Frame: 5 weeks ]
    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 [ Time Frame: 5 weeks ]
    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 [ Time Frame: Baseline and 5 weeks ]
    Total number of Audio recordings of snoring in different individuals in a baseline setting and using various anti-snoring solutions.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE In Home Assessment of Three Anti-Snoring Devices, a Cross Over Study
Official Title  ICMJE In Home Assessment of Three Anti-Snoring Devices, a Cross Over Study
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Snoring
Intervention  ICMJE
  • Device: 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/.
  • Device: 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.

  • Device: 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.
Study Arms  ICMJE
  • Active Comparator: Nasal Dilator
    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
    Intervention: Device: Nasal Dilator
  • Active Comparator: Mandibular Advancement
    Mandibular advancement devices have shown to be effective, but not necessarily acceptable to primary snorers.
    Intervention: Device: Mandibular Advancement
  • Active Comparator: Positional Therapy
    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: Device: Positional Therapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 8, 2019)
58
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE December 3, 2017
Actual Primary Completion Date December 3, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03333876
Other Study ID Numbers  ICMJE SRC-AI-SilentNight-10090
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Coded data will be shared with the Philips Research in the Netherlands.
Supporting Materials: Study Protocol
Supporting Materials: Informed Consent Form (ICF)
Time Frame: At close of the data collection period that data will be available for analysis. The coded data will be available indefinitely
Access Criteria: Those that have access will be trained to Philips procedures.
Responsible Party Philips Respironics
Study Sponsor  ICMJE Philips Respironics
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Philips Respironics
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP