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

Sleep Disorder Clinical Trial

— RONCO  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05031585
• Other study ID #: HYP 002-21
• Status: Recruiting
• Phase: N/A
• Start date: February 18, 2022
• Est. completion date: September 30, 2022

Study information

• Verified date: March 2022
• Source: Brainfarma Industria Química e Farmacêutica S/A
• Contact: Cosmed Indústria de Cosméticos e Medicamentos S/A
• Phone: +55 11 45072111
• Email: juliana.augusto[@]brainfarma.ind.br
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: September 30, 2022
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Sleep Disorder
• Sleep Wake Disorders
• Snoring

Intervention

Device:
• Roncoliv
The medical device with nasal spray solution should be used 1 time a day, before bedtime, for 30 days.
• Placebo
The medical device with placebo should be used 1 time a day, before bedtime, for 30 days.

Locations

Country	Name	City	State
Brazil	Núcleo Interdisciplinar Da Ciencia Do Sono	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Brainfarma Industria Química e Farmacêutica S/A

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	General participant well-being.	Questioning during medical consultation	Through study completion, an average of 30 days
Primary	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	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
Secondary	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
Secondary	Perception of snoring reduction by the partner	Questioning during medical consultation	30 days of medical device use
Secondary	The effect of nasal lubricant on apnea observed on polysomnography	Apnea and hypopnea index	30 days of medical device use
Secondary	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
Secondary	The effect of nasal lubricant on sleep quality using the standardized Sleep Apnea Quality Life Index (SAQLI) questionnaire		30 days of medical device use
Secondary	The effect of nasal lubricant on sleep quality using the Berlin Questionnaire / STOP-BANG Questionnaire		30 days of medical device use
Secondary	The effect of nasal lubricant on oximetry, in residence using Biologix®.		Through study completion, an average of 30 days
Secondary	The effect of nasal lubricant on snoring index, in residence using Biologix®.		Through study completion, an average of 30 days