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

Brainfarma

Status: Unknown

Conditions: Snoring; Sleep Disorder

Treatments: Device: Roncoliv; Device: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05031585

HYP 002-21

Details and patient eligibility

About

Pivotal clinical trial, multicenter of superiority, randomized, double-blind, parallel groups, placebo-controlled and use of nasal lubricant on snoring.

Full description

This study is designed for the improvement of snoring, characterized by a noise caused by the vibration of tissues obstructing the nasopharynx and oropharynx during sleep.

It is performed in participants of both sexes, over 18 years of age, who complain of snoring.

The rationale for studying the use of a medical device with nasal spray solution for snoring improvement is due to the fact that surface tension in the pharyngeal mucosa plays an important role in determining airway collapsibility.

Enrollment: 90 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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90 participants in 2 patient groups, including a placebo group

Intervention Group

Experimental group

Description:

Nasal lubricant spray

Treatment:

Device: Roncoliv

Placebo

Placebo Comparator group

Description:

Placebo spray

Treatment:

Device: Placebo