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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02021903
Other study ID # 1120008
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 2012
Est. completion date June 2020

Study information

Verified date August 2020
Source University Hospital, Toulouse
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


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Study Design


Intervention

Other:
V1: HGPO + meal and V2: placebo + meal
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
V1: placebo 75mg + meal and V2: HGPO 75mg + meal
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

Locations

Country Name City State
France UHBordeaux Bordeaux
France UHToulouse Toulouse

Sponsors (2)

Lead Sponsor Collaborator
University Hospital, Toulouse Ministry of Health, France

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Secondary 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
Secondary 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 ; 120 minutes
Secondary 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
Secondary 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
Secondary 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
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