Intraoral Tongue Stimulation for Treatment of Primary Snoring

NCT03829956 | Completed

• 1 other identifier: Snoozeal
• Study Type: interventional
• Target: 115
• Locations: 1 country
• Sites: 1

Brief Summary

Intraoral Neuromuscular Training for Treatment of Snoring Objective Studies show that improving pharyngeal muscle tone can ameliorate obstructive sleep apnoea (OSA) and snoring. The study uses an intra-oral stimulation device (SnooZeal) aimed at a population of snorers. The aim of this study is to assess the efficacy of intra-oral neuromuscular stimulation training during wakefulness on snoring. Methods This is a prospective study, recruiting up to 200 patients from the sleep clinics. In this study, subjects will use the intra-oral stimulation device once a day for 20 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 2 weeks after treatment. They will complete Pittsburgh Sleep Quality Index (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, visual analogue scale (VAS) snoring scores, PSQI and subjective sleep quality questionnaire. All side effects and adverse events will be reported and acted upon according to the risk management structure.

Conditions

Snoring; Obstructive Sleep Apnea

Keywords

snoring; obstructive sleep apnoea; hypopnoea

Outcome Measures

Primary Outcomes (2)

• Reduction in snoring levels greater than 40dB

  Reduction of 20 % in the percentage of time spent snoring at levels greater than 40 dB. This will be achieved using WatchPat (510K - K161579) sleep studies

  Change between pre-therapy (day -14 to -1) and end of therapy (day 43-49)

• Visual analogue scale (VAS) snoring scores

  Visual analogue scale (VAS) of snoring is a subjective assessment of the participant's severity of scoring by their partner on a scale of 1 - 10 (1 being no snoring, 10 being intolerable snoring). This assessment will be done on a daily basis for the 2 weeks prior to intervention, 6 weeks of intervention and 2 weeks post intervention.

  Change between average of pre-therapy (day -14 to day -1), during therapy (day 29 to 42) and post therapy (day 43 to 56)

Secondary Outcomes (2)

• Pittsburgh Sleep Quality Index (PSQI)

  Change between pre-therapy (day -1) and post therapy (day 56)

• Epworth Sleepiness Scale (ESS)

  Change between pre-therapy (day -1) and post therapy (day 56)

Study Arms (1)

Snoring and mild OSA

OTHER

This cohort of participants has been diagnosed with primary snoring or mild obstruction sleep apnoea. A medical device (intra-oral tongue stimulation device) will be introduced for 6 weeks and the effects will be assessed by comparing the outcome measures before and after the intervention.

Device: Intraoral tongue stimulator (Snoozeal)

Interventions

Intraoral tongue stimulator (Snoozeal) DEVICE

Electrical stimulation of the tongue muscle to improve muscle tone to treat primary snoring and mild obstructive sleep apnea.

Snoring and mild OSA

Eligibility Criteria

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

You may qualify if:

• Age 18 years and above at entry into study
• Subjects must have a live-in partner
• \> 6 months history of habitual snoring (\>5 days per week)

You may not qualify if:

• Body Mass Index \> 35
• 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
• Certain oral disease/conditions (see Appendix 3)
• 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 (1)

Redbridge, Barking and Havering NHS Trust

London, United Kingdom

Location

Related Publications (2)

• Nokes B, Baptista PM, de Apodaca PMR, Carrasco-Llatas M, Fernandez S, Kotecha B, Wong PY, Zhang H, Hassaan A, Malhotra A. Transoral awake state neuromuscular electrical stimulation therapy for mild obstructive sleep apnea. Sleep Breath. 2023 May;27(2):527-534. doi: 10.1007/s11325-022-02644-9. Epub 2022 May 27.

  PMID: 35624401 DERIVED

• Kotecha B, Wong PY, Zhang H, Hassaan A. A novel intraoral neuromuscular stimulation device for treating sleep-disordered breathing. Sleep Breath. 2021 Dec;25(4):2083-2090. doi: 10.1007/s11325-021-02355-7. Epub 2021 Mar 26.

  PMID: 33772397 DERIVED

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

• Bhik Kotecha

  University College London Hospitals

  PRINCIPAL INVESTIGATOR

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: January 13, 2017
• First Posted: February 4, 2019
• Study Start: February 4, 2019
• Primary Completion: April 14, 2020
• Study Completion: April 14, 2020
• Last Updated: September 27, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)