An interventional study of Roncoliv and Placebo in Snoring and Sleep Disorder, sponsored by Brainfarma Industria Química e Farmacêutica S/A. Status unknown at 1 site in Brazil. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-07-19.
Sponsored by Brainfarma Industria Química e Farmacêutica S/A (part of Hypera Pharma) · Not applicable, Interventional, and Supportive care
Pivotal clinical trial, multicenter of superiority, randomized, double-blind, parallel groups, placebo-controlled and use of nasal lubricant on snoring.
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.
122 studies on the registry are indexed under Snoring; 15 are open to participants now.
This study's planned enrollment of 90 is above the median of 43 across 95 interventional studies indexed under Snoring.
Browse Snoring studies →Brainfarma Industria Química e Farmacêutica S/A is the lead sponsor of 15 studies on the registry; 7 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Nasal lubricant spray
Device: Roncoliv
Placebo spray
Device: Placebo
The medical device with nasal spray solution should be used 1 time a day, before bedtime, for 30 days.
The medical device with placebo should be used 1 time a day, before bedtime, for 30 days.
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.
Time frame: 30 days of medical device use
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®
Time frame: 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®
Time frame: 30 days of medical device use
Perception of snoring reduction by the partner
Questioning during medical consultation
Time frame: 30 days of medical device use
The effect of nasal lubricant on apnea observed on polysomnography
Apnea and hypopnea index
Time frame: 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.
Time frame: 30 days of medical device use
The effect of nasal lubricant on sleep quality using the standardized Sleep Apnea Quality Life Index (SAQLI) questionnaire
Time frame: 30 days of medical device use
The effect of nasal lubricant on sleep quality using the Berlin Questionnaire / STOP-BANG Questionnaire
Time frame: 30 days of medical device use
The effect of nasal lubricant on oximetry, in residence using Biologix®.
Time frame: Through study completion, an average of 30 days
The effect of nasal lubricant on snoring index, in residence using Biologix®.
Time frame: Through study completion, an average of 30 days
Adverse event rate, evaluated from questioning or spontaneous reporting of serious and non-severe adverse events and findings on clinical examinations.
Time frame: Through study completion, an average of 30 days
General participant well-being.
Questioning during medical consultation
Time frame: Through study completion, an average of 30 days
Started Feb 2022 (actual). Primary completion is estimated for Sep 2022, 7 months after the start.
Of 45 interventional studies with no phase under Snoring, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 31. This study's planned 7 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.
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