PatientsVille.com LogoPatientsVille.com

Parkinsonian Disorders | Post-prandial Hypotension and Sleepiness in Parkinson's Disease and Other Synucleinopathies

Parkinsonian Disorders research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Parkinsonian Disorders

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Other:V1: HGPO + meal and V2: placebo + mealAmbulatory 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

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

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

HGPO + PlaceboV1: HGPO 75 mg + meal and V2: Placebo 75 mg + meal

Placebo + HGPOV1: Placebo 75 mg + meal and V2: HGPO 75 mg + meal

Study Status

Recruiting

Start Date: May 2012

Completed Date: June 2018

Phase: N/A

Type: Interventional

Design:

Primary Outcome: Rate of patients presenting a "sleep onset"

Secondary Outcome: rate of patients without arterial hypotension nor a sleep episode within 120 minutes after oral solution administration ;

Study sponsors, principal investigator, and references

Principal Investigator: Anne Pavy-Le Traon, MD

Lead Sponsor: University Hospital, Toulouse

Collaborator: Ministry of Health, France

More information:https://clinicaltrials.gov/show/NCT02021903

Discuss Hypotension