Donepezil for Residual Symptoms in CPAP Treated Obstructive Sleepapnea Patients: A Controlled Study
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- subjective excessive daytime sleepiness
研究概览
简要总结
It is a randomized, double-blind, single-center, 30-day study. Patients aged 35-60 years, with apnea and hypopnea index and respiratory disturbance index normalized with CPAP, and Epworth Sleepiness Scale> 11. Patients undergo baseline and CPAP titration polysomnography, liquor and blood collection, Multiple Sleep Latency Test, anxiety and depression and cognitive assessments.
详细描述
Obstructive Sleep Apnea (OSA) is a sleep-disordered breathing characterized by recurrent episodes of total or partial obstruction of the upper airway during sleep, which can lead to cognitive, metabolic and cardiovascular consequences. More recently, OSA has been associated with worsening Alzheimer's disease symptoms. Resolving respiratory events during sleep often has a beneficial impact on these consequences. However, even after adequate and optimized treatment with continuous positive airway pressure (CPAP), about 6 to 10% of patients still remain sleepy. Given the high prevalence of OSA, this percentage represents a large number of under-treated and at-risk individuals. This residual excessive sleepiness (RES) may be related to comorbidities and cognitive alterations. Its physiopathology is still unknown. A few studies have tested modafinil as an adjunct treatment for RES patients. Since a) CPAP is ineffective in patients with RES; b) previous studies suggest some benefit with wake promoters; and c) cognitive impairment has also been reported associated with RES; the hypothesis of the present study is that donepezil improves alertness and cognition in patients with OSA and RES, evidencing the role of the cholinergic system in the pathophysiology of RES.
Objective
To evaluate the effects of donepezil on RES in adult patients treated with CPAP.
Thirty-six patients diagnosed with OSA and RES are estimated to be included. Participants will be treated with CPAP for more than 6 months with a mean use greater than 5 hours per day. After blood and cerebrospinal fluid collection, patients will be randomized into 2 groups of 30 days of treatment with donepezil or placebo. RES will be evaluated by the vigilance test and the Epworth Sleepiness Scale.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
donepezil and placebo will be dispensed to volunteers in similar pills and numbered boxes.
入排标准
- 年龄范围
- 35 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Both gender, Age between 35 and 65 years;
- •Confirmed diagnosis of moderate to severe OSA;
- •Treatment with CPAP for at least six months;
- •Persistent sleepiness with daily CPAP use compliance > 5 hours per night.
排除标准
- •Neurological or psychiatric diseases;
- •Chronic use of psychoactive drugs, other sleep disorders than OSA, visual defficiency, illiteracy.
研究组 & 干预措施
donepezil treatment
donepezil with 10 mg will be administered for 30 days.
干预措施: donepezil treatment (Drug)
placebo treatment
placebo with 10 mg placebo will be administered for 30 days.
干预措施: donepezil treatment (Drug)
结局指标
主要结局
subjective excessive daytime sleepiness
时间窗: 40 days
Epworth Sleepiness Scale
objective excessive daytime sleepiness
时间窗: 40 days
Maintenance Wakefulness Test
次要结局
- cognitive improvement (executive functions)(40 days)
研究者
Dalva Poyares
MD Professor
Associação Fundo de Incentivo à Pesquisa