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:
2025-12-24 @ 11:32 PM
Ignite Modification Date:
2025-12-24 @ 11:32 PM
NCT ID:
NCT03160456
Eligibility Criteria:
Inclusion Criteria:
* mild-moderate OSA (AHI 5-35/hour)
* difficulties with or failed CPAP and/or withdrawn from standard care (CPAP \<4hours/night)
* Body mass index (BMI) 18.5-32 kg/m2
* No significant anatomical obstruction in the upper airway (e.g. normal sized tonsils).
Exclusion Criteria:
* No OSA (AHI \<5/h)
* Severe obstructive sleep apnoea (AHI\>35/hour)
* Exclusively postural sleep apnoea
* isolated Rapid-Eye-Movement (REM) sleep associated OSA
* Cachexia (BMI \<18.5 kg/m2)
* Obesity (BMI \>32 kg/m2)
* Hypercapnic respiratory failure (pCO2\>6.5 kPa)
* Features of obesity hypoventilation syndrome (elevated bicarbonate, HCO3- \>28mmol/L).
* enlarged tonsils (size 3-4)
* polyps and adenoids
* neuromuscular disease
* hypoglossal nerve palsy
* abnormal pulmonary function tests
* severe pulmonary hypertension
* valvular heart disease
* heart failure (New York Heart Association, NYHA III-IV)
* myocardial infarction and significant cardiac arrhythmias
* uncontrolled hypertension
* active psychiatric disease
* co-existing non-respiratory sleep disorder
* significant metal implants or cardiac/other pacemakers.
* facial hair that affects the correct placement of the hydrogel patch
* endoscopically identified contraindication to upper airway stimulation (multi-level obstruction)
These criteria are consistent with our experience from previous trials using transcutaneous electrical stimulation in OSA and likely to identify potential responders; these criteria are also similar to those from trials using hypoglossal nerve stimulation.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT03160456
Study Brief:
Protocol Section:
NCT03160456