A Feasibility Study to Determine the Effects of a Novel Mattress Support for Treatment of Positional Obstructive Sleep Apnea at Home
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 2
- 主要终点
- Apnea-Hypopnea Index Difference Between Two Nights
研究概览
简要总结
- Determine the effects of a mattress support (Wave 4.3) that promotes the avoidance of supine airway position at home on the apnea-hypopnea index (AHI) in patients with positional obstructive sleep apnea (OSA).
- Determine the effects of Wave 4.3 on subjective measures of sleepiness and daytime function in patients with positional OSA.
- Determine the effects of Wave 4.3 on subjective measures of sleep quality in patients with positional OSA.
详细描述
This is a preliminary single-arm study. The study will last up to 4 weeks including the screening period. Subjects will sleep using the mattress support at home for two consecutive weeks.
Outcome measures will include: AHI derived from HSAT (primary outcome), oxygen desaturation index (ODI), Epworth Sleepiness Scale (ESS) score, Functional Outcomes of Sleep Questionnaire (FOSQ), Visual Analog Scale (VAS) and questionnaire assessments of sleep quality, and actigraphic sleep measures. Subjects will also keep a sleep diary every night for the duration of the study. Subjects will be asked about their bed partners' report on snoring and witnessed apneas.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •• 18-75 years of age
- •Willing and able to give informed consent
- •Able to speak and understand English
- •Previous sleep study prior to enrollment done based on previous clinical evaluation by the subject's treating physician in the course of usual clinical care:
- •overall AHI 5-40 events/hr.
- •at least 10% time spent in the supine and 10% time in the non-supine positions.
- •APOC I and APOC II
- •central respiratory events < 50% of the total number of apneas and hypopneas
- •Using at least a queen-sized mattress when sleeping at home
- •Patients who meet the above criteria who have been prescribed CPAP or dental device but are non-adherent to treatment will be enrolled in the study. CPAP non-adherence will be defined as average nightly use < 4hrs/night based on a download of the CPAP machine, or self- acknowledged discontinuation or non-regular of CPAP use.
排除标准
- •• Incapable of giving informed consent
- •Under the age of 18
- •Active titration of medication
- •Pregnancy, lactation (will be screened with urine pregnancy test)
- •Self-reported Substance abuse (current)
- •Excessive alcohol consumption
- •Excessive alcohol use is defined as:
- •More than 3 glasses of wine a day
- •More than 3 beers a day
- •More than 60 mL of hard liquor a day
- •Use of home oxygen
- •Presence of severe daytime sleepiness defined as an Epworth sleepiness scale score > 16 or a prior history of falling asleep while driving
- •Presence of cardiac pacemaker or automatic implantable cardioverter-defibrillator (AICD).
- •Unstable medical problem such as uncontrolled hypertension.
- •Body Mass Index (BMI) >45 kg/m2
- •Any other clinically significant condition that, in the opinion of the investigators, might put the subject at risk of harm during the study or might adversely affect the interpretation of the study data.
结局指标
主要结局
Apnea-Hypopnea Index Difference Between Two Nights
时间窗: 2 nights
Apnea-Hypopnea Index derived from Home Sleep Test. The apnea-hypopnea index (AHI) is the combined average number of apneas and hypopneas that occur per hour of sleep between two nights. AHI\<5 is indicative of no sleep apnea, AHI 5-15 is indicative of mild sleep apnea, AHI 15-30 is indicative of moderate sleep apnea, AHI\>30 is indicative of severe sleep apnea. The minimum AHI is 0, and there is no maximum. A higher score means a worse outcome. Subscales are not used to compute the value. The difference was calculated based on the value at night 1 minus the value at night 2 (converted to a positive value if the difference created a negative value). The mean value was calculated by adding the difference based on the total number of participants.
次要结局
- Epworth Sleepiness Score(Completed at Visit 1 and Visit 4 (~5 minutes))
- Functional Outcomes of Sleep Questionnaire Score(Completed at Visit 2 and Visit 4 (~5 minutes))
- Visual Analog Scale Score(Completed at Visit 2 and Visit 4 (~5 minutes))
- Oxygen Desaturation Index Difference Between Two Nights(2 nights)
研究者
Ulysses Magalang MD
Principal Investigator
Ohio State University