Which Place for Branched-chain Aminoacids in the Treatment of Sleep Apnea Syndromes?
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 发起方
- 主要终点
- The principal criterion of BCAA efficacy is based on the depth of arterial desaturation during sleep, assessed by the level of SaO2 during the validated sleep time measured during the polysomnography performed at the end of the study.
研究概览
简要总结
The initial hypothesis is that branched-chain aminoacids (BCAA) administration could be beneficial to patients suffering from sleep apnea syndrome (SAS), the aim of the present work is to verify this hypothesis.
The literature data demonstrate that a BCAA complementation improves the physical performances, protects lean mass and increases VO2 max during training.
We demonstrated earlier that this complementation can cure at less partly the hypoxemia of chronic obstructive pulmonary patients by a stimulation of respiratory centres.
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)
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
- •Adult with healthy mind, who has attained his majority, and affiliated to Social Security.
- •Patient suffering from SAS confirmed by polysomnography (PSG).
- •Written informed consent form signed.
排除标准
- •Patients receiving neuroleptics or benzodiazepines and affiliated drugs will not be included in the study.
- •Patients suffering for severe SAS : those who have a number of IAH higher than 30 in a validated sleep hour, will be excluded for security reasons.
- •Pregnant women, nursing mothers or women susceptible to procreate without efficient contraception.
- •Patient presenting hypersensitivity to understudying products and their excipients.
研究组 & 干预措施
Branched-chain aminoacids
Branched-chain aminoacids are natural constituents of the food. Branched-chain aminoacids will be orally administered in the form of capsules.
干预措施: Branched-chain aminoacids (Drug)
placebo
The placebo will be orally administered in the form of capsules
干预措施: Placebo (Drug)
结局指标
主要结局
The principal criterion of BCAA efficacy is based on the depth of arterial desaturation during sleep, assessed by the level of SaO2 during the validated sleep time measured during the polysomnography performed at the end of the study.
时间窗: 2 years
次要结局
- The secondary criteria are apnea and snore counting, the intergroup difference between the beginning and the end of treatment on nocturnal desaturations.(2 years)