Circadian Character of Food Compulsions and Impulses Control Disorders in Parkinsonian Patients With and Without Resting Leg Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- The percentage of daily night food intake measured at baseline + 15 day using the diary.
研究概览
简要总结
Investigator have recently shown that Parkinson disease patients' with restless leg Syndrome have more frequent impulse control behavior in particular compulsive feeding that patients without Restless Leg Syndrome (RLS).
Investigator hypothesized that presence of RLS in parkinsonian patients could be a risk factor for the emergence of TCI or associated behaviors, occurring preferentially at night.
The main objective of this study is to evaluate in patients with idiopathic Parkinson's disease (IPD) the effect of the presence of a RLS on the evening compulsive eating behavior by studying the circadian modulation of food intake of patients with RLS and impulse control disorders.
For this investigator conduct a prospective study, with 2 groups of Parkinson disease patients (with and without restless leg syndrome), to which investigator have to fill an agenda to know the schedule of the behaviors during the day and the night.
详细描述
Type of study: prospective, case control study Number of center: 1 (Clermont Ferrand)
Patients:
The study will be performed in 60 patients with Parkinson disease (30 with RLS and 30 without RLS)
Study Performance:
During the first visit (baseline, inclusion visit, 1 hour), each patient will perform an interview about medical history and a neurological examination in order to identify RLS (evaluation using the IRLSSG rating scale).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
盲法说明
no masking
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men or women, 18 to 80 years
- •Patients with a Parkinson disease (PD) with UKPDSBB criteria
- •with a medical treatment or other treatment, not modified 4 weeks before inclusion
- •Social security affiliation
- •Acceptance of the protocol and signature of a written consent
- •RLS group: Patients with IRLSSG criteria of RLS, with a frequency of RLS ≥ 2 times per week Group without RLS: Patients without IRLSSG criteria of RLS
排除标准
- •Patients with an other neurological disease than Parkinson's disease
- •Patients with secondary RLS (other than Parkinson's disease)
- •Patients with psychiatric diseases
- •Patients with cognitive disorder (MoCA <21)
- •Patients with body mass index <16.5 or >30
- •Patients with sleep-waking rhythm disorders (such as night work...)
- •Patients under trusteeship or guardianship or safeguarding of justice
研究组 & 干预措施
RLS-
patients with Parkinson disease without RLS
干预措施: Diary (for reporting all impulse control disorders especially compulsive eating disorders) (Behavioral)
RLS+
patients with Parkinson disease with RLS
干预措施: Diary (for reporting all impulse control disorders especially compulsive eating disorders) (Behavioral)
结局指标
主要结局
The percentage of daily night food intake measured at baseline + 15 day using the diary.
时间窗: at baseline + 15 day
次要结局
- Percentage of patients with compulsive food intake measured at baseline + 15 day(at baseline + 15 day)
- Percentage of patients with Sleep related eating disorders using the International classification of sleep disorders-third edition criteria measured at baseline + 15 days(at baseline + 15 day)
- Percentage of night behavior for the other impulse control disorders , measured at baseline + 15 day using the diary(at baseline + 15 day)
- Percentage of patients with the night eating syndrome using the Night Eating Questionnaire measured at baseline + 15 days(at baseline + 15 day)
- Percentage of patients with others impulse control disorders or other associated behavior measured at baseline + 15 day(at baseline + 15 day)
- sleep caracteristics measured at baseline + 15 days using the accelerometry data(at baseline + 15 day)