Evaluation of the Effectiveness of a Physical Activity Program on the Severity of Narcolepsy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change from baseline Narcolepsy Severity Scale (NSS) Score after training period.
研究概览
简要总结
Narcolepsy Type 1 (NT1) is a rare chronic neurological disorder resulting from the selective loss of hypocretin neurons. Patients with NT1 suffer from excessive daytime sleepiness, disrupted nighttime sleep, and cataplexy (emotionally triggered episodes of muscle atonia). The disease is associated with numerous comorbidities such as obesity, metabolic disorders, anxiety-depressive disorders, and attentional disorders, all of which have a strong impact on quality of life.
详细描述
Narcolepsy Type 1 (NT1) is a rare chronic neurological disorder resulting from the selective loss of hypocretin neurons. Patients with NT1 suffer from excessive daytime sleepiness, disrupted nighttime sleep, and cataplexy (emotionally triggered episodes of muscle atonia). The disease is associated with numerous comorbidities such as obesity, metabolic disorders, anxiety-depressive disorders, and attentional disorders, all of which have a strong impact on quality of life.
Current management is based on sleep hygiene as well as wake-promoting and anti-cataplectic medications. However, many patients complain of residual sleepiness or cataplexy. In addition, most of the proposed treatments are accompanied by side effects and have little effect on the comorbidities associated with the disease. Therapeutic alternatives are therefore needed in the management of narcolepsy.
Regular Physical Activity (RPA) is recommended by the World Health Organization (WHO) and has been shown to improve anxiety disorders, obesity, metabolic disorders, cognitive functions, sleep and quality of life.
In NT1, patients have fewer opportunities to practice RPA because of daytime sleepiness as well as increased sleep needs. Some studies suggest that cardiorespiratory performances may be lower in NT1 patients than in healthy controls, and that a higher level of physical activity may be associated with lower sleepiness and better metabolic profile in NT1 children. However, no prospective study has evaluated the feasibility of an exercise training program in NT1 or the effect of regular physical activity on disease severity.
The main objective of the study is to evaluate the effect of a physical activity training program of 3 sessions per week for 6 weeks on the severity of narcolepsy in sedentary adults with NT1.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Narcolepsy type 1 according to International Classification of Sleep Disorders, 3rd edition (ICSD 3-2014) criteria
- •Patients aged 18 to 65 years
- •Patients beneficiaries of social security
- •Signed consent to participate in the study
- •Access to a video conferencing device (smartphone, tablet or computer)
排除标准
- •- Patients with a high level of physical activity on the Ricci and Gagnon Questionnaire (score >35) and/or regular physical activity in clubs
- •Treatments not stabilized for less than 3 months
- •Cognitive disorders incompatible with the understanding and implementation of the program
- •Medical contraindication to exercise training
- •Patient working night shifts
- •Unstable somatic or psychiatric pathology
- •Severe untreated obstructive sleep apnea syndrome (apnea/hypopnea index >30/h)
- •Pregnancy in progress or breastfeeding
- •Persons deprived of liberty by a judicial or administrative decision,
- •Persons admitted to a health or social institution for purposes other than research
- •Persons of full age who are subject to a legal protection measure or who are unable to express their consent
结局指标
主要结局
Change from baseline Narcolepsy Severity Scale (NSS) Score after training period.
时间窗: before and after 6 weeks of physical activity program (training period)
The Narcolepsy Severity Scale is a validated scale exploring the different symptoms of NT1
次要结局
- Compliance with the training program.(weekly during the training period (up to 6 weeks))
- Narcolepsy Severity Scale (NSS) Score(At 6 months)
- Hospital and Anxiety Depression Scale score(At inclusion, at the end of the training program (6 weeks) and at 6 months)
- Frequency of cataplexy(every week during de training period (6 weeks))
- Lipid profile(Parameters will be measured at inclusion, at the end of the training program (6 weeks) and at 6 months*)
- sleep efficiency(Parameters will be measured at inclusion, at the end of the training program (6 weeks) and at 6 months*)
- Euroquol 5 dimensions questionnaire score(At inclusion, at the end of the training program (6 weeks) and at 6 months)
- body mass index(Parameters will be measured at inclusion, at the end of the training program (6 weeks) and at 6 months*)
- Bron/Lyon Attention Stability Test (BLAST) score(Parameters will be measured at inclusion, at the end of the training program (6 weeks))
- Maximal Oxygen consumption (VO2 max)(Parameters will be measured at inclusion, at the end of the training program (6 weeks))
- Fasting blood sugar(Parameters will be measured at inclusion, at the end of the training program (6 weeks) and at 6 months*)
- patient satisfaction score(Parameters will be measured at inclusion, at the end of the training program (6 weeks))