Phase
Condition
Sleep Disorders
Treatment
N/AClinical Study ID
Ages 18-65 All Genders
Study Summary
Eligibility Criteria
Inclusion
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
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 whenmouth 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 understandingof or compliance with study procedures
Pregnancy
Patient with severe Chronic Obstructive Pulmonary Disease
Asthmatic patient under inhaled corticoid therapy
Study Design
Connect with a study center
Poliklinika Šustova 1930/2
Praha 4, 149 00
CzechiaActive - Recruiting
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.