Parkinsonian DisordersHYPOSOMNPARKNCT02021903
Post-prandial Hypotension and Sleepiness in Parkinson's Disease and Other Synucleinopathies
A study of Parkinsonian Disorders, run by University Hospital, Toulouse at 2 sites in France.
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. Read more about this study
- Who is it for?
- Ages 35 to 85 years
- Conditions the study is for
- Parkinsonian Disorders
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- 2 sitesFrance
- Study dates
- May 2012to Jun 2020
- 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 35 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Post-prandial Hypotension and Sleepiness in Parkinson's Disease and Other Synucleinopathies: the Model of an Oral Glucose Load
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.
Read the 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.
- Conditions
- Parkinsonian Disorders
- Being tested
- V1: HGPO + meal and V2: placebo + meal, V1: placebo 75mg + meal and V2: HGPO 75mg + meal
- Keywords
- arterial hypotension, postprandial sleepiness, orthostatic hypotension, synucleinopathies, hyperglycemia
- Medical subject headings
- Parkinsonian Disorders, Hypotension, Hypotension, Orthostatic, Synucleinopathies, Hyperglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
V1: HGPO + meal and V2: placebo + mealOther
Also called V1: HGPO 75mg + meal and V2: placebo 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
V1: placebo 75mg + meal and V2: HGPO 75mg + mealOther
- 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
| Study group | Role | What they receive |
|---|---|---|
| HGPO + Placebo | Experimental | V1: HGPO 75 mg + meal and V2: Placebo 75 mg + meal Receives: Other: V1: HGPO + meal and V2: placebo + meal |
| Placebo + HGPO | Placebo comparator | V1: Placebo 75 mg + meal and V2: HGPO 75 mg + meal Receives: Other: V1: placebo 75mg + meal and V2: HGPO 75mg + meal |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 hours
Secondary outcomes (5)
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 ;
Measured: 120 minutes
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 ;
Measured: 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;
Measured: 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)
Measured: 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.
Measured: 120 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2013 (estimated)
- Study startMay 2012
- Primary completion20 Dec 2019
- Study completionJun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinsonian DisordersStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, France
- Responsible party
- Sponsor
- Investigators
- Anne Pavy-Le Traon, MD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02021903
- Sponsor's protocol ID
- 1120008
- Acronym
- HYPOSOMNPARK
- Status last verified
- Aug 2020
- First submitted
- 20 Dec 2013
- Last updated
- 25 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-prandial Hypotension and Sleepiness in Parkinson's Disease and Other Synucleinopathies: the Model of an Oral Glucose Load
- ClinicalTrials.gov ID
- NCT02021903
- Acronym / sponsor ID
- HYPOSOMNPARK / 1120008
- Conditions
- Parkinsonian Disorders
- Keywords
- arterial hypotension, postprandial sleepiness, orthostatic hypotension, synucleinopathies, hyperglycemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Collaborators
- Ministry of Health, France
- Study start
- May 2012
- Primary completion
- 20 Dec 2019 (actual)
- Study completion
- Jun 2020 (actual)
- First posted
- 27 Dec 2013 (estimated)
- 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.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HGPO + Placebo | Experimental | Other: V1: HGPO + meal and V2: placebo + mealV1: HGPO 75 mg + meal and V2: Placebo 75 mg + meal |
| Placebo + HGPO | Placebo comparator | Other: V1: placebo 75mg + meal and V2: HGPO 75mg + mealV1: Placebo 75 mg + meal and V2: HGPO 75 mg + meal |
Who may qualify
- Ages
- 35 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (11 listed)
- 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
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 |
|---|---|---|
| V1: HGPO + meal and V2: placebo + mealAlso: V1: HGPO 75mg + meal and V2: placebo 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 | Other | HGPO + Placebo |
| 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 | Other | Placebo + HGPO |
Primary outcome
Rate of patients presenting a "sleep onset"
Time frame: 2 hours
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.
5 secondary outcomes
rate of patients without arterial hypotension nor a sleep episode within 120 minutes after oral solution administration ;
Time frame: 120 minutes
rate of patients that show a sleep episode but without arterial hypotension within 120 minutes after oral solution administration ;
Time frame: 120 minutes
rate of patients that show arterial hypotension within 120 minutes after oral solution administration but not a sleep episode;
Time frame: 120 minutes
Occurrence of arterial hypotension and a sleep episode within 120 minutes following a standardized meal
Time frame: 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.
Time frame: 120 minutes
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 25 Aug 2020.
- Individual participant dataSharing planned: No
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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.
Anne Pavy-Le Traon, MD principal investigator
University Hospital, Toulouse
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Parkinsonian Disorders, run by University Hospital, Toulouse at 2 sites 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 5 inclusion and 11 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 25 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. Some participants in this study may receive a placebo. 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?
Rate of patients presenting a "sleep onset" (time frame: 2 hours). 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 25 Aug 2020.