The Efficacy of Intra-oral Neuromuscular Stimulation Training on Snoring in Individuals with Primary Snoring and Mild Sleep Apnoea

Phase 4

Completed

Conditions: apnea
Snoring
10046304

Registration Number: NL-OMON55000

Lead Sponsor: Signifier Medical Technologies

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 16

Inclusion Criteria

Participant is willing and able to give informed consent for participation in
the trial
Male or female, aged 18 years or above
AHI 5-15/hr as confirmed by polysomnography
Bedpartner

Exclusion Criteria

* BMI >35 kg/m2
* 5< AHI >15/h, i.e. evidence of moderate to severe OSA from polysomnography
* Symptomatic nasal pathology i.e. septal deviation, nasal polyposis or chronic
rhinosinusitis
* Tonsil Hypertrophy (Tonsil size * Grade 3 or greater)
* Tongue or lip piercing
* Pacemaker or implanted medical electrical devices
Pregnancy or planned pregnancy (device has not been tested or approved for use
in pregnant women)
* Previous oral surgery for snoring
* Relevant facial skeletal abnormalities (i.e. syndromic facial deficiencies,
severe micrognathia etc.)
* Any criteria that, in the opinion of the investigator, would make the
participant unsuitable for the study due to inability to complete required
study procedures

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary Objective<br /><br>1) To assess the efficacy of daytime trans-oral neuromuscular stimulation<br /><br>training on respiratory indices of Sleep disordered breathing<br /><br>Change in AHI and ODI (Comparison of pre and post therapy sleep studies)<br /><br>2) To assess the efficacy of daytime trans-oral neuromuscular stimulation<br /><br>training on objective snoring in Sleep disordered breathing<br /><br>Change in Objective snoring pre and post therapy (% snoring at 40, 45 and 50dB)</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary Objectives<br /><br>1) To assess the efficacy of daytime trans-oral neuromuscular stimulation<br /><br>training on snoring sleep quality.<br /><br>Comparison of sleep quality questionnaires at start and end of therapy (PSQI,<br /><br>ESS, EQ-5D-5L)<br /><br>2) To assess the efficacy of daytime trans-oral neuromuscular stimulation<br /><br>training on snoring reported by sleep partner<br /><br>Comparison of visual analogue scale of snoring reported by partner </p><br>