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

NCT05031585 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2022-07-19

No results posted yet for this study

Summary

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

Conditions

  • Snoring
  • Sleep Disorder

Interventions

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.

Sponsors & Collaborators

  • Brainfarma Industria Química e Farmacêutica S/A

    lead INDUSTRY

Principal Investigators

  • Brainfarma Indústria Química Farmacêutica · Brainfarma Industria Química e Farmacêutica S/A

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-02-18
Primary Completion
2022-09-30
Completion
2022-09-30

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05031585 on ClinicalTrials.gov