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

NCT03333876 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 58

Last updated 2019-02-15

Study results available
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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

Interventions

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.

Sponsors & Collaborators

  • Philips Respironics

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
21 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-10-09
Primary Completion
2017-12-03
Completion
2017-12-03
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03333876 on ClinicalTrials.gov