Sleep Disorder, Snoring
Conditions
Keywords
nasal lubricant, sleep, medical device
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.
Interventions
DEVICERoncoliv
The medical device with nasal spray solution should be used 1 time a day, before bedtime, for 30 days.
DEVICEPlacebo
The medical device with placebo should be used 1 time a day, before bedtime, for 30 days.
Sponsors
Brainfarma Industria Química e Farmacêutica S/A
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The effect of nasal lubricant in the improvement of snoring when compared to placebo. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The effect of nasal lubricant on snoring reduction during polysomnography | 30 days of medical device use | Qualitative noise evaluation through standardized algorithm with maximum noise peak (in dB), evaluated by Fusion SLM® sound level meter; Evaluation of oximetry, through Biologix® |
| Nasal lubricant on snoring reduction during polysomnography | 30 days of medical device use | Quantitative noise evaluation through standardized algorithm with maximum noise peak (in dB), evaluated by Fusion SLM® sound level meter; Evaluation of oximetry, through Biologix® |
| Perception of snoring reduction by the partner | 30 days of medical device use | Questioning during medical consultation |
| The effect of nasal lubricant on apnea observed on polysomnography | 30 days of medical device use | Apnea and hypopnea index |
| The effect of nasal lubricant on sleep quality using the standardized daytime sleepiness assessment questionnaire | 30 days of medical device use | 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. |
| The effect of nasal lubricant on oximetry, in residence using Biologix®. | Through study completion, an average of 30 days | — |
| The effect of nasal lubricant on snoring index, in residence using Biologix®. | Through study completion, an average of 30 days | — |
| The effect of nasal lubricant on sleep quality using the standardized Sleep Apnea Quality Life Index (SAQLI) questionnaire | 30 days of medical device use | — |
| The effect of nasal lubricant on sleep quality using the Berlin Questionnaire / STOP-BANG Questionnaire | 30 days of medical device use | — |
Other
| Measure | Time frame | Description |
|---|---|---|
| Adverse event rate, evaluated from questioning or spontaneous reporting of serious and non-severe adverse events and findings on clinical examinations. | Through study completion, an average of 30 days | — |
| General participant well-being. | Through study completion, an average of 30 days | Questioning during medical consultation |
Countries
Brazil
Contacts
Primary ContactCosmed Indústria de Cosméticos e Medicamentos S/A
Outcome results
None listed