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

NCT04392765 | Unknown

• 1 other identifier: eXciteOSA Multicentre
• Study Type: interventional
• Target: 200
• Locations: 4 countries
• Sites: 6

Brief 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

Outcome Measures

Primary Outcomes (3)

• Change in sleep disordered breathing indices - Apnea Hypopnea Index (AHI)

  To assess the efficacy of daytime trans-oral neuromuscular stimulation training on respiratory indices of Sleep disordered breathing (AHI)

  Change between pre-therapy (day 0) and post therapy (day 49)

• Change in sleep disordered breathing indices - Oxygen Desaturation Index (ODI)

  To assess the efficacy of daytime trans-oral neuromuscular stimulation training on respiratory indices of Sleep disordered breathing (ODI)

  Change between pre-therapy (day 0) and post therapy (day 49)

• Change in Objective snoring pre and post therapy

  To assess the efficacy of daytime trans-oral neuromuscular stimulation training on objective snoring in Sleep disordered breathing (% snoring at 40, 45 and 50dB)

  Change between pre-therapy (day 0) and post therapy (day 49)

Secondary Outcomes (4)

• Comparison of sleep quality questionnaires at start and end of therapy - Pittsburgh Sleep Quality Index (PSQI)

  Change between pre-therapy (day 7) and post therapy (day 49)

• Comparison of sleep quality questionnaires at start and end of therapy - Epsworth Sleepiness Score (ESS)

  Change between pre-therapy (day 7) and post therapy (day 49)

• Comparison of visual analogue scale (VAS) of snoring reported by partner

  Change between pre-therapy (day 7) and post therapy (day 49)

• Comparison of quality of life questionnaires at start and end of therapy - EQ-5D-5L

  Change between pre-therapy (day 7) and post therapy (day 49)

Study Arms (1)

Therapy arm

OTHER

Six week use of eXciteOSA device. Once daily for 20 minutes.

Device: eXciteOSA

Interventions

eXciteOSA DEVICE

eXciteOSA transoral neurostimulation device

Therapy arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 performed for screening purposes
• Snoring complaints for \>6 months
• In possession of a smartphone (to use the application)

You may not qualify if:

• BMI \>35 kg/m2
• AHI \>15/h, i.e. evidence of moderate to severe obstructive sleep apnoea (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
• Previous oral surgery for snoring
• Relevant facial skeletal abnormalities (i.e. syndromic facial deficiencies, severe micrognathia etc.)
• Pregnancy or planned pregnancy
• 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

Sponsors & Collaborators

• Signifier Medical Technologies: lead

Study Sites (6)

Vancouver Hospital

Vancouver, British Columbia, V5Z 1M9, Canada

Location

McGill University Health Centre

Montreal, Canada

Location

Advanced Sleep Research GMBH

Berlin, Germany

Location

OLVG, Amsterdam

Amsterdam, Netherlands

Location

Clínica Universidad de Navarra, Pamplona

Pamplona, Spain

Location

Hospital Universitario Doctor Peset, Valencia

Valencia, Spain

Location

MeSH Terms

Conditions

Snoring; Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Respiratory Sounds; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Yasser Zayni

  Signifier Medical Technologies

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2020
• First Posted: May 19, 2020
• Study Start: May 11, 2020
• Primary Completion: December 30, 2022
• Study Completion: September 30, 2023
• Last Updated: December 2, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2); ES (2); DE (1); NL (1)