Parkinson DiseaseRLS nighfoodNCT03818243
Circadian Character of Food Compulsions and Impulses Control Disorders in Parkinsonian Patients With and Without Resting Leg Syndrome
A study of Parkinson Disease and Restless Leg Syndrome, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Parkinson Disease, Restless Leg Syndrome
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteFrance
- Study dates
- 21 Jan 2019to 22 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Parkinson Disease, Restless Leg Syndrome
- Being tested
- Diary (for reporting all impulse control disorders especially compulsive eating disorders)
- Keywords
- Parkinson disease, Restless Leg Syndrome, Impulse control disorders, circadian rhythm
- Medical subject headings
- Parkinson Disease, Restless Legs Syndrome, Disruptive, Impulse Control, and Conduct Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diary (for reporting all impulse control disorders especially compulsive eating disorders)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| RLS- | Experimental | patients with Parkinson disease without RLS Receives: Behavioral: Diary (for reporting all impulse control disorders especially compulsive eating disorders) |
| RLS+ | Experimental | patients with Parkinson disease with RLS Receives: Behavioral: Diary (for reporting all impulse control disorders especially compulsive eating disorders) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percentage of daily night food intake measured at baseline + 15 day using the diary.
Measured: at baseline + 15 day
Secondary outcomes (6)
Percentage of night behavior for the other impulse control disorders , measured at baseline + 15 day using the diary
Measured: at baseline + 15 day
Percentage of patients with compulsive food intake measured at baseline + 15 day
Measured: at baseline + 15 day
Percentage of patients with others impulse control disorders or other associated behavior measured at baseline + 15 day
Measured: at baseline + 15 day
Percentage of patients with the night eating syndrome using the Night Eating Questionnaire measured at baseline + 15 days
Measured: 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
Measured: at baseline + 15 day
sleep caracteristics measured at baseline + 15 days using the accelerometry data
Measured: at baseline + 15 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2019
- Study start21 Jan 2019
- Primary completion16 Jun 2022
- Study completion22 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- the 2 groups (patients with Parkinson disease with and without RLS) received the same intervention
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ana MARQUES, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03818243
- Sponsor's protocol ID
- CHU-421
- Other IDs
- 2018-A02417-48
- Acronym
- RLS nighfood
- Status last verified
- Jul 2023
- First submitted
- 24 Jan 2019
- Last updated
- 10 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Circadian Character of Food Compulsions and Impulses Control Disorders in Parkinsonian Patients With and Without Resting Leg Syndrome
- ClinicalTrials.gov ID
- NCT03818243
- Acronym / sponsor ID
- RLS nighfood / CHU-421
- Conditions
- Parkinson Disease, Restless Leg Syndrome
- Keywords
- Parkinson disease, Restless Leg Syndrome, Impulse control disorders, circadian rhythm
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 21 Jan 2019 (actual)
- Primary completion
- 16 Jun 2022 (actual)
- Study completion
- 22 Jun 2023 (actual)
- First posted
- 28 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- the 2 groups (patients with Parkinson disease with and without RLS) received the same intervention
| Arm | Type | Receives |
|---|---|---|
| RLS- | Experimental | Behavioral: Diary (for reporting all impulse control disorders especially compulsive eating disorders)patients with Parkinson disease without RLS |
| RLS+ | Experimental | Behavioral: Diary (for reporting all impulse control disorders especially compulsive eating disorders)patients with Parkinson disease with RLS |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diary (for reporting all impulse control disorders especially compulsive eating disorders)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. | Behavioural | RLS+, RLS- |
Primary outcome
The percentage of daily night food intake measured at baseline + 15 day using the diary.
Time frame: at baseline + 15 day
6 secondary outcomes
Percentage of night behavior for the other impulse control disorders , measured at baseline + 15 day using the diary
Time frame: at baseline + 15 day
Percentage of patients with compulsive food intake measured at baseline + 15 day
Time frame: at baseline + 15 day
Percentage of patients with others impulse control disorders or other associated behavior measured at baseline + 15 day
Time frame: at baseline + 15 day
Percentage of patients with the night eating syndrome using the Night Eating Questionnaire measured at baseline + 15 days
Time frame: 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
Time frame: at baseline + 15 day
sleep caracteristics measured at baseline + 15 days using the accelerometry data
Time frame: at baseline + 15 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ana MARQUES principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Parkinson Disease and Restless Leg Syndrome, run by University Hospital, Clermont-Ferrand at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The percentage of daily night food intake measured at baseline + 15 day using the diary. (time frame: at baseline + 15 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2023.