Clinical trial NCT05031585: Efficacy and Safety Study of Nasal Lubricant Compared to Placebo on Snoring
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Snoring
Sleep Disorder
Keywords: nasal lubricant
sleep
medical device
Lead sponsor: Brainfarma Industria Química e Farmacêutica S/A
Sponsor class: INDUSTRY
First posted: 2021-09-02
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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).

Primary outcomes:
measure: The effect of nasal lubricant in the improvement of snoring when compared to placebo.
timeFrame: 30 days of medical device use
Secondary outcomes:
measure: The effect of nasal lubricant on snoring reduction during polysomnography
timeFrame: 30 days of medical device use
measure: Nasal lubricant on snoring reduction during polysomnography
timeFrame: 30 days of medical device use
measure: Perception of snoring reduction by the partner
timeFrame: 30 days of medical device use
measure: The effect of nasal lubricant on apnea observed on polysomnography
timeFrame: 30 days of medical device use
measure: The effect of nasal lubricant on sleep quality using the standardized daytime sleepiness assessment questionnaire
timeFrame: 30 days of medical device use
measure: The effect of nasal lubricant on sleep quality using the standardized Sleep Apnea Quality Life Index (SAQLI) questionnaire
timeFrame: 30 days of medical device use
measure: The effect of nasal lubricant on sleep quality using the Berlin Questionnaire / STOP-BANG Questionnaire
timeFrame: 30 days of medical device use
measure: The effect of nasal lubricant on oximetry, in residence using Biologix®.
timeFrame: Through study completion, an average of 30 days
measure: The effect of nasal lubricant on snoring index, in residence using Biologix®.
timeFrame: Through study completion, an average of 30 days
Other outcomes:
measure: Adverse event rate, evaluated from questioning or spontaneous reporting of serious and non-severe adverse events and findings on clinical examinations.
timeFrame: Through study completion, an average of 30 days
measure: General participant well-being.
timeFrame: Through study completion, an average of 30 days
Locations:
city: São Paulo
country: Brazil
facility: Núcleo Interdisciplinar Da Ciencia Do Sono
Study officials:
affiliation: Brainfarma Industria Química e Farmacêutica S/A
name: Brainfarma Indústria Química Farmacêutica
role: STUDY_DIRECTOR
References: