NeutraSal in the Management of Xerostomia in Obstructive Sleep Apnea Syndrome (OSAS) Patients Utilizing Continuous Positive Airway Pressure (CPAP) Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Change in Percentage of Time With CPAP (Continuous Positive Airway Pressure) Usage
研究概览
简要总结
To assess whether the daily use of NeutraSal will prevent or reduce dry mouth in patients undergoing CPAP therapy for OSAS and improve CPAP compliance
详细描述
Subjects diagnosed with Obstructive Sleep Apnea Syndrome (OSAS) who have started CPAP treatment and have complained of dry mouth or developed worsening of a pre-existing dry mouth as an effect of CPAP treatment will test the effectiveness of NeutraSal mouthwash in preventing or reducing his/her dry mouth perceptions and improving their compliance with CPAP.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 84 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient should be above 18 years of age.
- •Patients who have been initiated on CPAP therapy after an initial diagnosis of OSAS and have developed dry mouth or have worsening of pre-existing dry mouth condition, as an effect of CPAP therapy.
- •Ability to attend visits at the research site
- •Patient should be able to read and/or understand and sign the consent form be willing to participate in the research study
排除标准
- •Patients with open mouth sores at study entry.
- •Any pathology that, based on the judgement of the researcher, could negatively affect the oral mucosa and subsequent treatment for xerostomia (immune disorders, etc.)
- •Patients using any other prophylactic mouthwashes.
- •Patients who are pregnant and/or nursing.
- •Patients becoming pregnant during the treatment period will be removed from data.
- •Patients on a low sodium diet
- •Patients currently on medication or treatment for xerostomia
- •Patients < 18 years of age
- •Hypersensitivity to any of the following ingredients- sodium chloride, sodium phosphate, calcium chloride and sodium bicarbonate
研究组 & 干预措施
NeutraSal
NeutraSal, dosed 2 times per day at waking and bedtime (indications 2-10 times per day or PRN), swish and spit, daily for a term of 12 weeks.
干预措施: NeutraSal (Drug)
Placebo
Placebo dosed 2 times per day at waking and bedtime (indications 2-10 times per day or PRN), swish and spit, daily for a term of 12 weeks.
干预措施: Placebo Comparator (Drug)
结局指标
主要结局
Change in Percentage of Time With CPAP (Continuous Positive Airway Pressure) Usage
时间窗: Baseline and 12 weeks
To observe the impact of NeutraSal on OSAS (obstructive sleep apnoea syndrome) patients compliance to CPAP (Continuous Positive Airway Pressure) therapy compared to placebo. CPAP usage is determined by % of nights CPAP use was greater than 4 hours.
次要结局
- Mean Rate of Dry Mouth as Assessed by Xerostomia Questionnaire(Baseline through 12 weeks)