Status:
UNKNOWN
Efficacy of Intra-oral Neuromuscular Stimulation Training on Snoring and Mild Sleep Apnoea
Lead Sponsor:
Signifier Medical Technologies
Conditions:
Snoring
Sleep Apnea, Obstructive
Eligibility:
All Genders
18+ years
Phase:
NA
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 result...
Detailed Description
Study Design: Phase IV prospective, multi-centre post-market surveillance study. Each site will follow the pre-determined study protocol, collecting endpoint relevant data which will then be analysed...
Eligibility Criteria
Inclusion
- 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)
Exclusion
- 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
Key Trial Info
Start Date :
May 11 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2023
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT04392765
Start Date
May 11 2020
End Date
September 30 2023
Last Update
December 2 2022
Active Locations (6)
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1
Vancouver Hospital
Vancouver, British Columbia, Canada, V5Z 1M9
2
McGill University Health Centre
Montreal, Canada
3
Advanced Sleep Research GMBH
Berlin, Germany
4
OLVG, Amsterdam
Amsterdam, Netherlands