Intraoral Tongue Stimulation for Treatment of Snoring and Sleep Apnoea

• Research type

  Research Study

• Full title

  The Efficacy of Intra-oral Neuromuscular Stimulation Training on Snoring and Mild Obstructive Sleep Apnoea - A Pilot Study

• IRAS ID

  219271

• Contact name

  Bhik Kotecha

• Contact email

  bhik.kotecha@bhrhospitals.nhs.uk

• Sponsor organisation

  Snoozeal Limited

• Duration of Study in the UK

  0 years, 6 months, 1 days

• Research summary

  Oral Neuromuscular Training for Treatment of Snoring and Sleep Apnoea– A Pilot Study

  Objective

  Studies show that improving pharyngeal muscle tone can ameliorate obstructive sleep apnoea (OSA) and snoring. Our study uses an intra-oral stimulation device (SnooZeal) aimed at a population of snorers and mild OSA. The aim of this study is to assess the efficacy of intra-oral neuromuscular stimulation training during wakefulness on snoring and mild OSA.

  Methods

  This is a prospective observational cohort study, recruiting 34 patients (17 with mild OSA and 17 simple snoring) from the sleep clinics at the Department of Otorhinolaryngology, Head and Neck Surgery at the Queen’s Hospital, Romford.

  Inclusion criteria
  • Age 20-65
  • Male or female
  • Subjects must have a live-in partner
  • > 6 months history of habitual snoring (>5 days per week)

  Exclusion criteria
  • Epworth sleepiness score <10
  • Body Mass Index > 34
  • Apnoea-Hypopnoea Index >15
  • Symptomatic nasal pathology
  • Tonsil Hypertrophy (Tonsil size > Grade 2)
  • Tongue or lip piercing
  • Pacemaker or implanted medical electrical devices
  • Previous oral surgery for snoring
  • Relevant facial skeletal abnormalities

  In this study, subjects will use the intra-oral stimulation device twice a day for 25 minutes each time for a period of 6 weeks. During these 6 weeks, subjects will complete a daily diary of the device use and any side effects or adverse events. Partners also complete a daily snoring score.

  Subjects will be followed-up for a further 6 weeks after treatment. They will complete PSQI and subjective sleep quality questionnaires for a further 2 weeks. Partners will also complete the post treatment snoring scores. Sleep study will be repeated.

  Outcome measures

  The objective evaluation will be based on pre- and post-treatment sleep studies, VAS snoring scores, Pittsburgh Sleep Quality Index and subjective sleep quality questionnaire. All side effects and adverse events will be reported and acted upon according to the risk management structure.

• REC name

  London - Stanmore Research Ethics Committee

• REC reference

  17/LO/0895

• Date of REC Opinion

  21 Jun 2017

• REC opinion

  Further Information Favourable Opinion