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 @ 1:14 AM
Ignite Modification Date:
2025-12-25 @ 1:14 AM
NCT ID:
NCT03222193
Eligibility Criteria:
Inclusion Criteria:
* Man or woman ≥ 18 years and ≤ 65 years at the time of signing informed consent
* Listed as continuous snorer (snoring at least 4 nights/week)
* Answer "Extremely loud" or "very loud" to question 1 of SBPS at screening
* Answer "very severe" or "severe" to question 2 of SBPS at screening
* Answer "extremely" or "quite a bit" to question 3 of SBPS at screening
* Dated and signed informed consent
* BMI ≤ 35
Exclusion Criteria:
* Severe Mandibular retrognathia and micrognathia
* Narrow and deep palate (less than 3 cm wide)
* Lack of three consecutive teeth in the area of (15-16-17-18) or (25-26-27-28).
* Lingual or labial short frenulum (the tongue cannot reach the upper incisors when mouth can be opened for two fingers)
* Intolerable gag reflex
* Known nasal septal deviation
* Neck circumference \> 46 cm
* Patient currently treated for OSA
* Patient with AHI≥30 events/hour or with AHI\>15 and (SFI) Sleep Fragmentation Index \> 20
* Patient currently treated for central sleep apnoea
* Addiction to alcoholic beverages (5 drinks per day per NIAAA)
* Under constant pharmacological treatment for depression, anxiety, chronic pain, insomnia
* Hypertrophy of tonsils
* Macroglossia
* Hypertrophy of uvula
* Primary gastroesophageal reflux
* Any other pathology preventing subject from complying with the protocol
* Subject with recent oropharyngeal surgery or likely during the study
* Mental inability, unwillingness or language barrier precluding adequate understanding of or compliance with study procedures
* Pregnancy
* Patient with severe Chronic Obstructive Pulmonary Disease
* Asthmatic patient under inhaled corticoid therapy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT03222193
Study Brief:
Protocol Section:
NCT03222193