NCT05031585

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Brainfarma Industria Química e Farmacêutica S/A · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	Roncoliv	The medical device with nasal spray solution should be used 1 time a day, before bedtime, for 30 days.
DEVICE	Placebo	The medical device with placebo should be used 1 time a day, before bedtime, for 30 days.

Timeline

• Start date: 2022-02-18
• Primary completion: 2022-09-30
• Completion: 2022-09-30
• First posted: 2021-09-02
• Last updated: 2022-07-19

Locations

1 site across 1 country: Brazil