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

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

Detailed Description
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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.

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

Conditions
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Snoring, Sleep Disorder

Intervention / Treatment
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* Device: Roncoliv
* Device: Placebo


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Group<br>Nasal lubricant spray | Device: Roncoliv<br>* The medical device with nasal spray solution should be used 1 time a day, before bedtime, for 30 days.<br>|
| Placebo Comparator: Placebo<br>Placebo spray | Device: Placebo<br>* The medical device with placebo should be used 1 time a day, before bedtime, for 30 days.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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nasal lubricant, sleep, medical device