Efficacy and Safety Study of Nasal Lubricant Compared to Placebo on Snoring (RONCO)

This is an interventional supportive care trial for Snoring focused on measuring nasal lubricant, sleep, medical device Read More

Inclusion Criteria:

• Have signed the informed consent form;
• Participants of both genders aged ≥ 18 years;
• Report of snoring assessed objectively through the standardized criteria in the snoring noise domain in the Berlin questionnaire;

Exclusion Criteria:

• History of allergy or hypersensitivity to the components of the nasal lubricant;
• Fixed nasal obstruction;
• Upper Airway Infections active or present for less than 7 days;
• Use of benzodiazepines and sleep inducing drugs;
• Under treatment for sleep apnea of any modality currently or within the past 6 months;
• Hepatic insufficiency;
• Active neoplastic disease;
• Severe sleep apnea determined by polysomnography (AHI > 30);
• Moderate sleep apnea with presence of excessive daytime sleepiness;
• Clinically significant illness or surgery, at the discretion of the principal investigator, within 30 days prior to study inclusion;
• History of chemical dependence or alcohol abuse;
• Any neurological and psychiatric disease or significant laboratory finding present, unless adequately controlled with medication allowed in the protocol;
• Patients with laboratory tests of SGOT, SGTP or CPK increased by at least two times the upper value of normal at the time of study inclusion;
• Women who are pregnant or breastfeeding or who have the desire to become pregnant;
• History of infarction and stroke;
• Craniofacial malformation;
• BMI > 35 Kg/m2;
• IDO ≥ 30 events/h determined in residence by Biologix®;
• Have symptoms of COVID-19 (fever, cold, loss of smell, loss of taste, dry cough, sore throat, diarrhea, difficulty breathing, fatigue, body aches and pains, headache).