Circadian Character of Food Compulsions and Impulses Control Disorders in Parkinsonian Patients With and Without Resting Leg Syndrome (RLS nighfood)
Primary Purpose
Parkinson Disease, Restless Leg Syndrome
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Diary (for reporting all impulse control disorders especially compulsive eating disorders)
Sponsored by
About this trial
This is an interventional prevention trial for Parkinson Disease focused on measuring Parkinson disease, Restless Leg Syndrome, Impulse control disorders, circadian rhythm
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- Chu Clermont-Ferrand
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
RLS-
RLS+
Arm Description
patients with Parkinson disease without RLS
patients with Parkinson disease with RLS
Outcomes
Primary Outcome Measures
The percentage of daily night food intake measured at baseline + 15 day using the diary.
Secondary Outcome Measures
Percentage of night behavior for the other impulse control disorders , measured at baseline + 15 day using the diary
Percentage of patients with compulsive food intake measured at baseline + 15 day
Percentage of patients with others impulse control disorders or other associated behavior measured at baseline + 15 day
Percentage of patients with the night eating syndrome using the Night Eating Questionnaire measured at baseline + 15 days
Percentage of patients with Sleep related eating disorders using the International classification of sleep disorders-third edition criteria measured at baseline + 15 days
sleep caracteristics measured at baseline + 15 days using the accelerometry data
Full Information
NCT ID
NCT03818243
First Posted
January 24, 2019
Last Updated
July 7, 2023
Sponsor
University Hospital, Clermont-Ferrand
1. Study Identification
Unique Protocol Identification Number
NCT03818243
Brief Title
Circadian Character of Food Compulsions and Impulses Control Disorders in Parkinsonian Patients With and Without Resting Leg Syndrome
Acronym
RLS nighfood
Official Title
Circadian Character of Food Compulsions and Impulses Control Disorders in Parkinsonian Patients With and Without Resting Leg Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
January 21, 2019 (Actual)
Primary Completion Date
June 16, 2022 (Actual)
Study Completion Date
June 22, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Clermont-Ferrand
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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.
Detailed Description
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).
Parkinson disease severity will be assessed with the Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS UPDRS) and the Hoehn and Yahr scale.
Cognitive assessment will be evaluated with the Montreal Cognitive assessment (MoCA)
Blood test to explore plasma ferritin, renal function and plasma glucose. A diary to note all the impulse control behaviour will be given to each patient in order to be completed for the next visit.
Finally, an actimetry system (a watch) will be also provided for each patient in order to record the sleep-wake rhythm and to evaluate the quality and the duration of the sleep.
During the second visit (Baseline + 15 days), each patients will have :
a neuropsychological assessment (using the Ardouin scale of behavior in Parkinson's disease ASBPD)
an evaluation of the night eating disorders :
The night eating syndrome will be evaluated with Night Eating Questionnaire (NEQ)
The Sleep related eating disorders will be evaluated with the International classification of sleep disorders-third edition criteria
an evaluation of the Iimpulse control disorder using the questionnaire for impulsive-compulsive disorders in Parkinson's disease rating scale (QUIP RS).
A sleep and vigilance evaluation using the Epworth scale, the Parkinson's disease sleep scale, the single-question screen for rapid eye movement sleep behavior disorder and the REM sleep behavior disorder screening questionnaire.
Diary and actimetry will be recovered.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease, Restless Leg Syndrome
Keywords
Parkinson disease, Restless Leg Syndrome, Impulse control disorders, circadian rhythm
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
the 2 groups (patients with Parkinson disease with and without RLS) received the same intervention
Masking
None (Open Label)
Masking Description
no masking
Allocation
Non-Randomized
Enrollment
55 (Actual)
8. Arms, Groups, and Interventions
Arm Title
RLS-
Arm Type
Experimental
Arm Description
patients with Parkinson disease without RLS
Arm Title
RLS+
Arm Type
Experimental
Arm Description
patients with Parkinson disease with RLS
Intervention Type
Behavioral
Intervention Name(s)
Diary (for reporting all impulse control disorders especially compulsive eating disorders)
Intervention Description
During 7 days, at home, patients must report in their diary all their impulse control disorders especially their compulsive eating disorders. They will detailed each food intake and drink intake and the time.
Primary Outcome Measure Information:
Title
The percentage of daily night food intake measured at baseline + 15 day using the diary.
Time Frame
at baseline + 15 day
Secondary Outcome Measure Information:
Title
Percentage of night behavior for the other impulse control disorders , measured at baseline + 15 day using the diary
Time Frame
at baseline + 15 day
Title
Percentage of patients with compulsive food intake measured at baseline + 15 day
Time Frame
at baseline + 15 day
Title
Percentage of patients with others impulse control disorders or other associated behavior measured at baseline + 15 day
Time Frame
at baseline + 15 day
Title
Percentage of patients with the night eating syndrome using the Night Eating Questionnaire measured at baseline + 15 days
Time Frame
at baseline + 15 day
Title
Percentage of patients with Sleep related eating disorders using the International classification of sleep disorders-third edition criteria measured at baseline + 15 days
Time Frame
at baseline + 15 day
Title
sleep caracteristics measured at baseline + 15 days using the accelerometry data
Time Frame
at baseline + 15 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ana MARQUES
Organizational Affiliation
University Hospital, Clermont-Ferrand
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chu Clermont-Ferrand
City
Clermont-Ferrand
ZIP/Postal Code
63003
Country
France
12. IPD Sharing Statement
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Circadian Character of Food Compulsions and Impulses Control Disorders in Parkinsonian Patients With and Without Resting Leg Syndrome
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