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

A Pivotal, Double-blind, Parallel, Randomized, Multicenter, Superiority Clinical Trial to Evaluate the Efficacy and Safety of Nasal Lubricant Compared to Placebo on Snoring

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

Study Overview

• Status: Recruiting
• Conditions: Sleep Disorder; Snoring
• Intervention / Treatment: Device: Roncoliv; Device: Placebo

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Cosmed Indústria de Cosméticos e Medicamentos S/A; Phone Number: +55 11 45072111; Email: juliana.augusto@brainfarma.ind.br

Study Locations

• Brazil
  • São Paulo, Brazil
    • Recruiting
    • Núcleo Interdisciplinar Da Ciencia Do Sono
    • Contact: Geraldo Lorenzi Filho, Doctor; Phone Number: +55 11 97319-3954

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Intervention Group; Nasal lubricant spray	Device: Roncoliv; The medical device with nasal spray solution should be used 1 time a day, before bedtime, for 30 days.
PLACEBO_COMPARATOR: Placebo; Placebo spray	Device: Placebo; The medical device with placebo should be used 1 time a day, before bedtime, for 30 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	30 days of medical device use

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The effect of nasal lubricant on snoring reduction during polysomnography	Qualitative noise evaluation through standardized algorithm with maximum noise peak (in dB), evaluated by Fusion SLM® sound level meter; Evaluation of oximetry, through Biologix®	30 days of medical device use
Nasal lubricant on snoring reduction during polysomnography	Quantitative noise evaluation through standardized algorithm with maximum noise peak (in dB), evaluated by Fusion SLM® sound level meter; Evaluation of oximetry, through Biologix®	30 days of medical device use
Perception of snoring reduction by the partner	Questioning during medical consultation	30 days of medical device use
The effect of nasal lubricant on apnea observed on polysomnography	Apnea and hypopnea index	30 days of medical device use
The effect of nasal lubricant on sleep quality using the standardized daytime sleepiness assessment questionnaire	Epworth Sleepiness Scale (ESS) measures the chance of dozing on a scale of 0 to 3, 0 being no chance and 3 being a great chance.	30 days of medical device use
The effect of nasal lubricant on sleep quality using the standardized Sleep Apnea Quality Life Index (SAQLI) questionnaire		30 days of medical device use
The effect of nasal lubricant on sleep quality using the Berlin Questionnaire / STOP-BANG Questionnaire		30 days of medical device use
The effect of nasal lubricant on oximetry, in residence using Biologix®.		Through study completion, an average of 30 days
The effect of nasal lubricant on snoring index, in residence using Biologix®.		Through study completion, an average of 30 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse event rate, evaluated from questioning or spontaneous reporting of serious and non-severe adverse events and findings on clinical examinations.		Through study completion, an average of 30 days
General participant well-being.	Questioning during medical consultation	Through study completion, an average of 30 days

Collaborators and Investigators

• Sponsor: Brainfarma Industria Química e Farmacêutica S/A
• Investigators: Study Director: Brainfarma Indústria Química Farmacêutica, Brainfarma Industria Química e Farmacêutica S/A

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 18, 2022
• Primary Completion (ANTICIPATED): September 30, 2022
• Study Completion (ANTICIPATED): September 30, 2022

Study Registration Dates

• First Submitted: August 10, 2021
• First Submitted That Met QC Criteria: August 26, 2021
• First Posted (ACTUAL): September 2, 2021

Study Record Updates

• Last Update Posted (ACTUAL): July 19, 2022
• Last Update Submitted That Met QC Criteria: July 18, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: sleep; medical device; nasal lubricant
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms, Respiratory; Respiratory Sounds; Sleep Wake Disorders; Snoring
• Other Study ID Numbers: HYP 002-21

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No