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

Brainfarma Industria Química e Farmacêutica S/A90 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

QUADRUPLE

Enrollment

Conditions

Snoring Sleep Disorder

Interventions

RoncolivDEVICE

The medical device with nasal spray solution should be used 1 time a day, before bedtime, for 30 days.

PlaceboDEVICE

The medical device with placebo should be used 1 time a day, before bedtime, for 30 days.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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).

Locations (1)

Núcleo Interdisciplinar Da Ciencia Do Sono

São Paulo, Brazil

RECRUITING

Outcomes

Primary Outcomes

The effect of nasal lubricant in the improvement of snoring when compared to placebo.

For the primary endpoint, the level of continuous noise equivalent to the sound produced during sleep - LAeqT (equivalent-continuous sound pressure level), in dB(A), with a frequency filter in the weighting (sound level meter - Fusion SLM®) will be evaluated.