A Pivotal, Double-blind, Parallel, Randomized, Multicenter, Superiority Clinical Trial to Evaluate the Efficacy and Safety of Nasal Lubricant Compared to Placebo on Snoring
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- The effect of nasal lubricant in the improvement of snoring when compared to placebo.
研究概览
简要总结
Pivotal clinical trial, multicenter of superiority, randomized, double-blind, parallel groups, placebo-controlled and use of nasal lubricant on snoring.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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;
排除标准
- •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).
结局指标
主要结局
The effect of nasal lubricant in the improvement of snoring when compared to placebo.
时间窗: 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.
次要结局
- The effect of nasal lubricant on snoring reduction during polysomnography(30 days of medical device use)
- The effect of nasal lubricant on snoring index, in residence using Biologix®.(Through study completion, an average of 30 days)
- Perception of snoring reduction by the partner(30 days of medical device use)
- The effect of nasal lubricant on apnea observed on polysomnography(30 days of medical device use)
- The effect of nasal lubricant on sleep quality using the standardized daytime sleepiness assessment questionnaire(30 days of medical device use)
- 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)
- The effect of nasal lubricant on oximetry, in residence using Biologix®.(Through study completion, an average of 30 days)
- Nasal lubricant on snoring reduction during polysomnography(30 days of medical device use)