Post-prandial Hypotension and Sleepiness in Parkinson's Disease and Other Synucleinopathies (HYPOSOMNPARK)
Primary Purpose
Parkinsonian Disorders
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
V1: HGPO + meal and V2: placebo + meal
V1: placebo 75mg + meal and V2: HGPO 75mg + meal
Sponsored by
About this trial
This is an interventional diagnostic trial for Parkinsonian Disorders focused on measuring arterial hypotension, postprandial sleepiness, orthostatic hypotension, synucleinopathies, hyperglycemia
Eligibility Criteria
Inclusion Criteria:
- Aged 35 to 85
- Parkinson's disease patients (UKPDSBB diagnostic criteria), patients with Dementia with Lewy Bodies (DLB consortium criteria, Mc Keith et al. 2005) or patients with Multiple System Atrophy (Gilman's criteria, 2008) complaining of a post-prandial sleepiness interfering with their daily living and with orthostatic hypotension
- Stable antiparkinsonian treatments (including those for dysautonomia) for the 2 months before the study and during the entire study
- Signed written informed consent for the present study
- Social security insurance coverage
Exclusion Criteria:
- atypical or secondary parkinsonism
- patients without excessive daytime sleepiness
- inability to give a consent due to severe cognitive dysfunction
- severe depression
- Deep brain stimulation treatment
- Moderate to severe obstructive sleep apnoea/hypopnoea syndrome or other co-morbidities that could account for abnormal daytime sleepiness
- Severe primary or secondary insomnia
- Treatment with sedative medications (unless moderate and stable treatment for more than 2 months before entering the study and maintained at stable dosage during all the study)
- Diabetes mellitus
- Systolic arterial pressure at rest in seated position lower than 100 mmHg in sitting position
- Pregnancy and suckling
Sites / Locations
- UHBordeaux
- UHToulouse
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
HGPO + Placebo
Placebo + HGPO
Arm Description
V1: HGPO 75 mg + meal and V2: Placebo 75 mg + meal
V1: Placebo 75 mg + meal and V2: HGPO 75 mg + meal
Outcomes
Primary Outcome Measures
Rate of patients presenting a "sleep onset"
Rate of patients presenting a "sleep onset", defined as the occurrence of at least 30 s of sleep at polysomnography or at patient's recall) with or without occurrence of hypotension (defined as a drop in systolic blood pressure level of at least 20 mmHg) during the 2 hours following oral glucose load or placebo fructose.
Secondary Outcome Measures
rate of patients without arterial hypotension nor a sleep episode within 120 minutes after oral solution administration ;
rate of patients without arterial hypotension nor a sleep episode within 120 minutes after oral solution administration ;
rate of patients that show a sleep episode but without arterial hypotension within 120 minutes after oral solution administration ;
rate of patients that show a sleep episode but without arterial hypotension within 120 minutes after oral solution administration ;
rate of patients that show arterial hypotension within 120 minutes after oral solution administration but not a sleep episode;
rate of patients that show arterial hypotension within 120 minutes after oral solution administration but not a sleep episode;
Occurrence of arterial hypotension and a sleep episode within 120 minutes following a standardized meal
Occurrence of arterial hypotension (defined as a drop in systolic blood pressure level of at least 20 mmHg and a sleep episode (defined according to video-polygraphic parameters) within 120 minutes following a standardized meal (at lunch time)
Changes in intestine-pancreatic neuropeptides including incretins (GLP-1 - GIP) following an oral glucose load, placebo fructose load, or standardized meal - correlation with the post-prandial BP drop.
Changes in intestine-pancreatic neuropeptides including incretins (GLP-1 - GIP) following an oral glucose load, placebo fructose load, or standardized meal - correlation with the post-prandial BP drop.
Full Information
NCT ID
NCT02021903
First Posted
December 20, 2013
Last Updated
August 24, 2020
Sponsor
University Hospital, Toulouse
Collaborators
Ministry of Health, France
1. Study Identification
Unique Protocol Identification Number
NCT02021903
Brief Title
Post-prandial Hypotension and Sleepiness in Parkinson's Disease and Other Synucleinopathies
Acronym
HYPOSOMNPARK
Official Title
Post-prandial Hypotension and Sleepiness in Parkinson's Disease and Other Synucleinopathies: the Model of an Oral Glucose Load
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
May 2012 (undefined)
Primary Completion Date
December 20, 2019 (Actual)
Study Completion Date
June 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Toulouse
Collaborators
Ministry of Health, France
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Excessive daytime sleepiness (EDS) is observed in 30 to 50 % of patients with Parkinson's disease (PD) patients, Dementia with Lewy Bodies (DLB) and Multiple System Atrophy (MSA). It is a major complain and represents a socially relevant problem as unintended episodes of sleep can also occur while driving for example. Arterial hypotension is frequently observed in patients with PD, DLB and MSA and considered as a marker of autonomic failure. Sleepiness is known to occur preferentially when patients are having arterial hypotension whatever the cause (i.e. postprandial period, administration of hypotensive medication such as dopamine agonists). We hypothesize that arterial hypotension is associated with abnormal sleepiness. We have observed this association in an on-going epidemiological survey Hyperglycaemia induced by oral glucose load - a standardized model simulating food intake during a meal - provokes arterial hypotension in the majority of Parkinson's disease patients with dysautonomia. It can be hypothesised that sleep attacks in these patients could be mediated by this fall in blood pressure.
Detailed Description
Excessive daytime sleepiness (EDS) is observed in 30 to 50 % of patients with Parkinson's disease (PD) patients, Dementia with Lewy Bodies (DLB) and Multiple System Atrophy (MSA). It is a major complain and represents a socially relevant problem as unintended episodes of sleep can also occur while driving for example. The exact pathophysiology of EDS in PD, DLB and MSA has not been fully elucidated so far, although pharmacological factors (dopaminergic medications) and pathological factors (neurodegeneration of sleep-wakefulness regulatory areas) have been identified. Arterial hypotension is frequently observed in patients with PD, DLB and MSA and considered as a marker of autonomic failure. Sleepiness is known to occur preferentially when patients are having arterial hypotension whatever the cause (i.e. postprandial period, administration of hypotensive medication such as dopamine agonists). We hypothesize that arterial hypotension is associated with abnormal sleepiness. We have observed this association in an on-going epidemiological survey (COPARK Cohort of 800 PD patients, manuscript in preparation). Hyperglycaemia induced by oral glucose load - a standardized model simulating food intake during a meal - provokes arterial hypotension in the majority of Parkinson's disease patients with dysautonomia. It can be hypothesised that sleep attacks in these patients could be mediated by this fall in blood pressure.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinsonian Disorders
Keywords
arterial hypotension, postprandial sleepiness, orthostatic hypotension, synucleinopathies, hyperglycemia
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
21 (Actual)
8. Arms, Groups, and Interventions
Arm Title
HGPO + Placebo
Arm Type
Experimental
Arm Description
V1: HGPO 75 mg + meal and V2: Placebo 75 mg + meal
Arm Title
Placebo + HGPO
Arm Type
Placebo Comparator
Arm Description
V1: Placebo 75 mg + meal and V2: HGPO 75 mg + meal
Intervention Type
Other
Intervention Name(s)
V1: HGPO + meal and V2: placebo + meal
Other Intervention Name(s)
V1: HGPO 75mg + meal and V2: placebo 75mg + meal
Intervention Description
Ambulatory polysomnography for the night preceding each test
Usual antiparkinsonian treatments at their usual dose and timing
Randomisation to receive an oral solution of glucose load or a placebo (fructose). Standard meal 4 hours after the test
During two hours following the oral solution administration and the standardized meal, we will perform the followings for each patient :
continuous digital blood pressure monitoring by Nexfin®
blood pressure monitoring at brachial artery
continuous polysomnographic recording
synchronized continuous digital audiovisual recording
glucose and insulin blood level monitoring Additional blood samples will be taken in order to assay the intestine-pancreatic neuropeptides including incretins GLP- 1 and GIP
Intervention Type
Other
Intervention Name(s)
V1: placebo 75mg + meal and V2: HGPO 75mg + meal
Intervention Description
Ambulatory polysomnography for the night preceding each test
Usual antiparkinsonian treatments at their usual dose and timing
Randomisation to receive an oral solution of glucose load or a placebo (fructose). Standard meal 4 hours after the test
During two hours following the oral solution administration and the standardized meal, we will perform the followings for each patient :
continuous digital blood pressure monitoring by Nexfin®
blood pressure monitoring at brachial artery
continuous polysomnographic recording
synchronized continuous digital audiovisual recording
glucose and insulin blood level monitoring Additional blood samples will be taken in order to assay the intestine-pancreatic neuropeptides including incretins GLP- 1 and GIP
Primary Outcome Measure Information:
Title
Rate of patients presenting a "sleep onset"
Description
Rate of patients presenting a "sleep onset", defined as the occurrence of at least 30 s of sleep at polysomnography or at patient's recall) with or without occurrence of hypotension (defined as a drop in systolic blood pressure level of at least 20 mmHg) during the 2 hours following oral glucose load or placebo fructose.
Time Frame
2 hours
Secondary Outcome Measure Information:
Title
rate of patients without arterial hypotension nor a sleep episode within 120 minutes after oral solution administration ;
Description
rate of patients without arterial hypotension nor a sleep episode within 120 minutes after oral solution administration ;
Time Frame
120 minutes
Title
rate of patients that show a sleep episode but without arterial hypotension within 120 minutes after oral solution administration ;
Description
rate of patients that show a sleep episode but without arterial hypotension within 120 minutes after oral solution administration ;
Time Frame
120 minutes
Title
rate of patients that show arterial hypotension within 120 minutes after oral solution administration but not a sleep episode;
Description
rate of patients that show arterial hypotension within 120 minutes after oral solution administration but not a sleep episode;
Time Frame
120 minutes
Title
Occurrence of arterial hypotension and a sleep episode within 120 minutes following a standardized meal
Description
Occurrence of arterial hypotension (defined as a drop in systolic blood pressure level of at least 20 mmHg and a sleep episode (defined according to video-polygraphic parameters) within 120 minutes following a standardized meal (at lunch time)
Time Frame
120 minutes
Title
Changes in intestine-pancreatic neuropeptides including incretins (GLP-1 - GIP) following an oral glucose load, placebo fructose load, or standardized meal - correlation with the post-prandial BP drop.
Description
Changes in intestine-pancreatic neuropeptides including incretins (GLP-1 - GIP) following an oral glucose load, placebo fructose load, or standardized meal - correlation with the post-prandial BP drop.
Time Frame
120 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Aged 35 to 85
Parkinson's disease patients (UKPDSBB diagnostic criteria), patients with Dementia with Lewy Bodies (DLB consortium criteria, Mc Keith et al. 2005) or patients with Multiple System Atrophy (Gilman's criteria, 2008) complaining of a post-prandial sleepiness interfering with their daily living and with orthostatic hypotension
Stable antiparkinsonian treatments (including those for dysautonomia) for the 2 months before the study and during the entire study
Signed written informed consent for the present study
Social security insurance coverage
Exclusion Criteria:
atypical or secondary parkinsonism
patients without excessive daytime sleepiness
inability to give a consent due to severe cognitive dysfunction
severe depression
Deep brain stimulation treatment
Moderate to severe obstructive sleep apnoea/hypopnoea syndrome or other co-morbidities that could account for abnormal daytime sleepiness
Severe primary or secondary insomnia
Treatment with sedative medications (unless moderate and stable treatment for more than 2 months before entering the study and maintained at stable dosage during all the study)
Diabetes mellitus
Systolic arterial pressure at rest in seated position lower than 100 mmHg in sitting position
Pregnancy and suckling
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anne Pavy-Le Traon, MD
Organizational Affiliation
University Hospital, Toulouse
Official's Role
Principal Investigator
Facility Information:
Facility Name
UHBordeaux
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Facility Name
UHToulouse
City
Toulouse
ZIP/Postal Code
31059
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Post-prandial Hypotension and Sleepiness in Parkinson's Disease and Other Synucleinopathies
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