SnoringRONCONCT05031585
Efficacy and Safety Study of Nasal Lubricant Compared to Placebo on Snoring
A study testing Roncoliv in people with Snoring and Sleep Disorder, run by Brainfarma Industria Química e Farmacêutica S/A at 1 site in Brazil.
Trial summary
Pivotal clinical trial, multicenter of superiority, randomized, double-blind, parallel groups, placebo-controlled and use of nasal lubricant on snoring. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Snoring, Sleep Disorder
- What is being tested?
- Roncoliv
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteBrazil
- Study dates
- 18 Feb 2022to 30 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
Who cannot join
- 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;
Show all 19Show fewer
- 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).
Trial locations and contacts
1 site in 1 country.
Cosmed Indústria de Cosméticos e Medicamentos S/A contact
Brazil1 site, 1 recruiting
- Recruiting
Núcleo Interdisciplinar Da Ciencia Do Sono
São Paulo
Geraldo Lorenzi Filho, Doctor, +55 11 97319-3954
About this study
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
Pivotal clinical trial, multicenter of superiority, randomized, double-blind, parallel groups, placebo-controlled and use of nasal lubricant on snoring.
Read the 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
- Being tested
- Roncoliv, Placebo
- Keywords
- nasal lubricant, sleep, medical device
- Medical subject headings
- Snoring, Sleep Wake Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RoncolivDevice
The medical device with nasal spray solution should be used 1 time a day, before bedtime, for 30 days.
PlaceboDevice
The medical device with placebo should be used 1 time a day, before bedtime, for 30 days.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Nasal lubricant spray Receives: Device: Roncoliv |
| Placebo | Placebo comparator | Placebo spray Receives: Device: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 days of medical device use
Secondary outcomes (9)
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®
Measured: 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®
Measured: 30 days of medical device use
Perception of snoring reduction by the partner
Questioning during medical consultation
Measured: 30 days of medical device use
The effect of nasal lubricant on apnea observed on polysomnography
Apnea and hypopnea index
Measured: 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.
Measured: 30 days of medical device use
The effect of nasal lubricant on sleep quality using the standardized Sleep Apnea Quality Life Index (SAQLI) questionnaire
Measured: 30 days of medical device use
The effect of nasal lubricant on sleep quality using the Berlin Questionnaire / STOP-BANG Questionnaire
Measured: 30 days of medical device use
The effect of nasal lubricant on oximetry, in residence using Biologix®.
Measured: Through study completion, an average of 30 days
The effect of nasal lubricant on snoring index, in residence using Biologix®.
Measured: Through study completion, an average of 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2021
- Study start18 Feb 2022
- Primary completion30 Sep 2022 (estimated)
- Study completion30 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SnoringStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brainfarma Industria Química e Farmacêutica S/A
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Brainfarma Indústria Química Farmacêutica, Study director, Brainfarma Industria Química e Farmacêutica S/A
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05031585
- Sponsor's protocol ID
- HYP 002-21
- Acronym
- RONCO
- Status last verified
- Mar 2022
- First submitted
- 10 Aug 2021
- Last updated
- 19 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05031585
- Acronym / sponsor ID
- RONCO / HYP 002-21
- Conditions
- Snoring, Sleep Disorder
- Keywords
- nasal lubricant, sleep, medical device
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Brainfarma Industria Química e Farmacêutica S/AIndustry (pharma, biotech, devices)
- Study start
- 18 Feb 2022 (actual)
- Primary completion
- 30 Sep 2022 (estimated)
- Study completion
- 30 Sep 2022 (estimated)
- First posted
- 2 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Device: RoncolivNasal lubricant spray |
| Placebo | Placebo comparator | Device: PlaceboPlacebo spray |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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;
Key exclusion criteria (19 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RoncolivThe medical device with nasal spray solution should be used 1 time a day, before bedtime, for 30 days. | Device | Intervention Group |
| PlaceboThe medical device with placebo should be used 1 time a day, before bedtime, for 30 days. | Device | Placebo |
Primary outcome
The effect of nasal lubricant in the improvement of snoring when compared to placebo.
Time frame: 30 days of medical device use
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.
9 secondary outcomes
The effect of nasal lubricant on snoring reduction during polysomnography
Time frame: 30 days of medical device use
Nasal lubricant on snoring reduction during polysomnography
Time frame: 30 days of medical device use
Perception of snoring reduction by the partner
Time frame: 30 days of medical device use
The effect of nasal lubricant on apnea observed on polysomnography
Time frame: 30 days of medical device use
The effect of nasal lubricant on sleep quality using the standardized daytime sleepiness assessment questionnaire
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2022.
Related trials for Snoring
RecruitingPhase 3
A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Do Not Use a Breathing Machine (PAP) (VESPER-OSA 2)
Apnea, Sleep Disorders
RecruitingObservational study
Prediction of Tongue Base Obstruction During Sleep
Obstructive Sleep Disordered Breathing
Active, not recruiting
The Impact of Technology in Obstructive Sleep Apnea Myofunctional Therapy
Obstructive Sleep Apnea (OSA), Snoring
Active, not recruiting
DISE: Phenotyping Obstruction Patterns
Obstructive Sleep Apnea
RecruitingPhase 1
Use of Passive Myofunctional Appliances for Snoring and Mild Obstructive Sleep Apnea
Sleep Apnea, Obstructive
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cosmed Indústria de Cosméticos e Medicamentos S/A contact
Brainfarma Indústria Química Farmacêutica study director
Brainfarma Industria Química e Farmacêutica S/A
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Roncoliv in people with Snoring and Sleep Disorder, run by Brainfarma Industria Química e Farmacêutica S/A at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cosmed Indústria de Cosméticos e Medicamentos S/A (+55 11 45072111, juliana.augusto@brainfarma.ind.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The effect of nasal lubricant in the improvement of snoring when compared to placebo. (time frame: 30 days of medical device use). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2022.