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| Name | Class |
|---|---|
| Ministry of Health, France | OTHER_GOV |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HGPO + Placebo | Experimental | V1: HGPO 75 mg + meal and V2: Placebo 75 mg + meal |
|
| Placebo + HGPO | Placebo Comparator | V1: Placebo 75 mg + meal and V2: HGPO 75 mg + meal |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| V1: HGPO + meal and V2: placebo + meal | Other |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 2 hours |
| Measure | Description | Time Frame |
|---|---|---|
| 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 ; | 120 minutes |
| rate of patients that show a sleep episode but without arterial hypotension within 120 minutes after oral solution administration ; |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anne Pavy-Le Traon, MD | University Hospital, Toulouse | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UHBordeaux | Bordeaux | 33076 | France | |||
| UHToulouse |
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| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D007022 | Hypotension |
| D007024 | Hypotension, Orthostatic |
| D000080874 | Synucleinopathies |
| D006943 | Hyperglycemia |
| ID | Term |
|---|---|
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D062407 | Meals |
| ID | Term |
|---|---|
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
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|
|
| V1: placebo 75mg + meal and V2: HGPO 75mg + meal | Other |
|
|
rate of patients that show a sleep episode but without arterial hypotension within 120 minutes after oral solution administration ; |
| 120 minutes |
| 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; | 120 minutes |
| 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) | 120 minutes |
| 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. | 120 minutes |
| Toulouse |
| 31059 |
| France |
| D009069 | Movement Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D054971 | Orthostatic Intolerance |
| D054969 | Primary Dysautonomias |
| D001342 | Autonomic Nervous System Diseases |
| D019636 | Neurodegenerative Diseases |
| D057165 | Proteostasis Deficiencies |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D044882 | Glucose Metabolism Disorders |