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

Not Applicable

• Conditions: Sleep Disorder; Snoring
• Interventions: Device: Placebo; Device: Roncoliv

• Registration Number: NCT05031585
• Lead Sponsor: Brainfarma Industria Química e Farmacêutica S/A

Brief Summary

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

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 Timeline

• Study First Submitted: 2021-08-10
• Study First Submitted QC: 2021-08-26
• Study First Posted: 2021-09-02
• Study Start: 2022-02-18
• Status Verified: 2022-03
• Last Update Submitted: 2022-07-18
• Last Update Posted: 2022-07-19
• Primary Completion: 2022-09-30
• Study Completion: 2022-09-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo spray
Intervention Group	Roncoliv	Nasal lubricant spray

Primary Outcome Measures

Name	Time	Method
The effect of nasal lubricant in the improvement of snoring when compared to placebo.	30 days of medical device use	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.

Secondary Outcome Measures

Name	Time	Method
The effect of nasal lubricant on snoring reduction during polysomnography	30 days of medical device use	Qualitative noise evaluation through standardized algorithm with maximum noise peak (in dB), evaluated by Fusion SLM® sound level meter; Evaluation of oximetry, through Biologix®
The effect of nasal lubricant on snoring index, in residence using Biologix®.	Through study completion, an average of 30 days
Perception of snoring reduction by the partner	30 days of medical device use	Questioning during medical consultation
The effect of nasal lubricant on apnea observed on polysomnography	30 days of medical device use	Apnea and hypopnea index
The effect of nasal lubricant on sleep quality using the standardized daytime sleepiness assessment questionnaire	30 days of medical device use	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.
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
Nasal lubricant on snoring reduction during polysomnography	30 days of medical device use	Quantitative noise evaluation through standardized algorithm with maximum noise peak (in dB), evaluated by Fusion SLM® sound level meter; Evaluation of oximetry, through Biologix®

Trial Locations

Locations (1)

Núcleo Interdisciplinar Da Ciencia Do Sono; 🇧🇷 São Paulo, Brazil