Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:34 AM
Ignite Modification Date:
2025-12-25 @ 1:34 AM
NCT ID:
NCT03913494
Eligibility Criteria:
Inclusion Criteria:
• Confirmation of snoring: must have a live-in bed partner that reports ≥ 6 months history of habitual snoring (i.e. \> 5 days per week)
Exclusion Criteria:
* AHI \> 15/hr
* BMI \> 35
* Non-English speakers (due to necessity to complete questionnaires)
* Inability to complete daily neuromuscular stimulation
* Other sleep disorders
* Tongue or lip piercing
* Pacemaker of implanted medical electrical devices
* Current or recent (within last 6 months) treatment for snoring or sleep apnea
* Previous oral or pharyngeal surgery other than dental
* Craniofacial skeletal or muscular abnormalities
* History of driving or other accidents due to sleepiness or an Epworth score (ESS)\> 18
* Pregnant
* Cardiac (other than hypertension), pulmonary, renal, neurologic, neuromuscular or hepatic disease
* Medications with sedative or myorelaxant properties or effects on cardiac or pulmonary function
* Substantial alcohol (\>3oz/day) or use of illicit drugs
* Psychiatric disorders (other than depression or anxiety)
* Snoring less than 20% of total sleep time during baseline polysomnography
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT03913494
Study Brief:
Protocol Section:
NCT03913494