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

NCT03333876 | Completed Results FDA Device

• 1 other identifier: SRC-AI-SilentNight-10090
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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."

Conditions

Snoring

Outcome Measures

Primary Outcomes (1)

• 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.

  5 weeks

Secondary Outcomes (4)

• Users Acceptance of Each Solution

  5 weeks

• Understand User Acceptance of the Bed Partner of Each Solution

  5 weeks

• Overall Satisfaction of the Bed Partner of Each Solution

  5 weeks

• Total Number of Audio Recordings

  Baseline and 5 weeks

Study Arms (3)

Nasal Dilator

ACTIVE COMPARATOR

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

Device: Nasal Dilator

Mandibular Advancement

ACTIVE COMPARATOR

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

Device: Mandibular Advancement

Positional Therapy

ACTIVE COMPARATOR

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.

Device: Positional Therapy

Interventions

Nasal Dilator DEVICE

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/.

Nasal Dilator

Mandibular Advancement DEVICE

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.

Mandibular Advancement

Positional Therapy DEVICE

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

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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) \[These individuals may be included in the study if recruitment timeline dictates it\]

You may not qualify if:

• 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

Sponsors & Collaborators

• Philips Respironics: lead

Study Sites (1)

Philips Respironics

Murrysville, Pennsylvania, 15668, United States

Location

MeSH Terms

Conditions

Snoring

Interventions

Mandibular Advancement

Condition Hierarchy (Ancestors)

Respiratory Sounds; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Oral Surgical Procedures; Surgical Procedures, Operative; Dentistry; Orthodontics

Results Point of Contact

• Title: Noah Papas
• Organization: Philips Respironics

Noah.Papas@philips.com

4122776436

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 30, 2017
• First Posted: November 7, 2017
• Study Start: October 9, 2017
• Primary Completion: December 3, 2017
• Study Completion: December 3, 2017
• Last Updated: February 15, 2019
• Results First Posted: February 15, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, 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.

Locations

US (1)