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Efficacy of Intra-oral Neuromuscular Stimulation Training on Snoring and Mild Sleep Apnoea

NCT04392765 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2022-12-02

No results posted yet for this study

Summary

It has been shown that a common cause for snoring and throat obstruction (obstructive sleep apnoea (OSA)) is excessive loss of muscle tone in the throat when the investigators go to sleep. This results in the partial collapse of the throat (snoring) or complete collapse (OSA) during sleep.

45% of the male population snore. Sleep apnoea affects 4 to 6% of the population and is associated with increased incidence of raised blood pressure, heart attacks and strokes. Although there are several lifestyle practices associated with snoring such as smoking, obesity and drinking, a significant proportion of people may snore despite not being associated with these.

A solution to this issue is to improve the muscle tone of the throat so that it doesn't collapse so easily. Several studies have shown that certain types of throat exercises can help reduce snoring. Further studies have also shown that using electrical stimulation to exercise the tongue muscles has the same effect.

From this, doctors in the United Kingdom (UK) have developed a new type of device, eXciteOSA, that allows a more accurate and comfortable way of delivering this energy to exercise the tongue muscles. The device works by stimulating the tongue muscles during the day so that the tongue is less likely to collapse during sleep. It is a form of "workout" for the tongue and like other physical exercise regimes, it needs to be repeated regularly for a few weeks to take effect.

The aim of this study is to see if the eXciteOSA device is as effective as the previous methods and if it can reduce snoring and improve sleep quality.

This will be achieved by participants using the eXciteOSA once daily for a six week period. A two night sleep study with watchPAT along with a polysomnography will be completed before and after the therapy to compare results. Questionnaires on sleep quality and quality of life will also be completed pre and post therapy.

Conditions

  • Snoring
  • Sleep Apnea, Obstructive

Interventions

DEVICE

eXciteOSA

eXciteOSA transoral neurostimulation device

Sponsors & Collaborators

  • Signifier Medical Technologies

    lead INDUSTRY

Principal Investigators

  • Yasser Zayni · Signifier Medical Technologies

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-05-11
Primary Completion
2022-12-30
Completion
2023-09-30

Countries

  • Canada
  • Germany
  • Netherlands
  • Spain

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 NCT04392765 on ClinicalTrials.gov