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

NCT ID: NCT05031585

Last Updated: 2022-07-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-18
• Study Completion Date: 2022-09-30

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.

Conditions

Snoring; Sleep Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: QUADRUPLE

Study Groups

Intervention Group

Nasal lubricant spray

Group Type: EXPERIMENTAL

Roncoliv

Intervention Type: DEVICE

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

Placebo

Placebo spray

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DEVICE

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

Interventions

Roncoliv

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

Intervention Type: DEVICE

Placebo

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

Intervention Type: DEVICE

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Brainfarma Industria Química e Farmacêutica S/A

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Brainfarma Indústria Química Farmacêutica

Role: STUDY_DIRECTOR

Brainfarma Industria Química e Farmacêutica S/A

Locations

Núcleo Interdisciplinar Da Ciencia Do Sono

São Paulo, , Brazil

Site Status: RECRUITING

Countries

Brazil

Central Contacts

Cosmed Indústria de Cosméticos e Medicamentos S/A

Role: CONTACT

juliana.augusto@brainfarma.ind.br

+55 11 45072111

Facility Contacts

Geraldo Lorenzi Filho, Doctor

Role: primary

+55 11 97319-3954

Other Identifiers

HYP 002-21

Identifier Type: -

Identifier Source: org_study_id