NL-OMON55000
Completed
Phase 4
The Efficacy of Intra-oral Neuromuscular Stimulation Training on Snoring in Individuals with Primary Snoring and Mild Sleep Apnoea - eXciteOSA study (Snoozeal)
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- apnea
- Sponsor
- Signifier Medical Technologies
- Enrollment
- 16
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Participant is willing and able to give informed consent for participation in
- •Male or female, aged 18 years or above
- •AHI 5\-15/hr as confirmed by polysomnography
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
Outcomes
Primary Outcomes
Not specified
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