Normal Pressure Hydrocephalus and Sleep Apnea (NPH/OSA)
Primary Purpose
Normal Pressure Hydrocephalus, Sleep Apnea, Cerebrospinal Fluid Shunt Occlusion
Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
CSF shunt diversion
Sponsored by
About this trial
This is an interventional treatment trial for Normal Pressure Hydrocephalus focused on measuring Normal pressure hydrocephalus, Sleep apnea, CSF shunt diversion, Ventriculo-peritoneal shunt, Ventriculo-atrial shunt
Eligibility Criteria
Inclusion Criteria:
- Clinical condition compatible with normal-pressure hydrocephalus
Exclusion Criteria:
- Cerebral vascular disease
- Dementia not due to normal-pressure hydrocephalus
- Parkinson's disease
Sites / Locations
- Vicente VanaclochaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Normal-pressure hydrocephalus only
Normal-pressure hydrocephalus with sleep apnea
Arm Description
Patients suffering from normal-pressure hydrocephalus with NO sleep apnea
Patients suffering from normal-pressure hydrocephalus with sleep apnea
Outcomes
Primary Outcome Measures
Change of hydrocephalus symptoms with Mini-Mental State Examination
Patients will be evaluated with the Mini_mental State Examination before and after CSF shunting to see the degree of improvement they get from this surgical treatment
Change of hydrocephalus symptoms with NPH scale after CSF shunt diversion
Patients will be evaluated with the NPH before and after CSF shunting to see the degree of improvement they get from this surgical treatment
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04471740
Brief Title
Normal Pressure Hydrocephalus and Sleep Apnea
Acronym
NPH/OSA
Official Title
Normal-pressure Hydrocephalus. Relationship Between Sleep Apnea and Intracranial and Intraabdominal Pressures. Outcome Prognostic Factors in CSF Shunting. Features Guiding to Implant a Ventricle-peritoneal Versus a Ventriculo-atrial Shunt
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 2, 2020 (Actual)
Primary Completion Date
July 2, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Valencia
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
Normal-pressure hydrocephalus is associated with increases in the intracranial pressure during the night sleep. Sleep apnea also increases the intracranial pressure during the apneic spells. When patients are operated the distal part of the shunt is inserted inside the abdominal cavity, which pressure also increases during the sleep apnea episodes. this is particularly important considering that the recumbent position used to sleep further increases the intraabdominal pressure and that impairs the CSF drainage through the shunt system. The purpose of this study is to analyze the intracranial and intraabdominal pressures during the sleep, particularly during the sleep apnea episodes to see which shunt should be used, to which cavity should be drained (peritoneum or heart) and if correcting the sleep apnea has some positive result on the hydrocephalus symptoms.
Detailed Description
Chronic hydrocephalus in adults, also known as normal pressure hydrocephalus or normal pressure hydrocephalus, occurs with the classic Hakim-Adams triad, gait ataxia, or "magnetic gait", urinary incontinence and dementia.
Most of the cases have an idiopathic origin and are the only potentially reversible cause of dementia with surgical treatment (by shunting the cerebrospinal fluid or CSF from the lateral ventricles or the thecal sac to the peritoneal cavity or the right atrium), so it is especially important to diagnose it and treat it properly.
Unfortunately, and despite all the diagnostic arsenal, the results of treatment using cerebrospinal fluid shunts (lumbo-peritoneal or ventricle-peritoneal), even in the best series, show 20-25% of poor results. These poor results have been attributed to many factors, including associated cerebral vascular pathology problems, co-existing dementia symptoms not always well diagnosed, Parkinson's disease, and, lastly, alterations in ventilatory rhythm. during the night, specifically obstructive sleep apnea or OSA.
In reality, the name of normotensive hydrocephalus or hydrocephalus at normal pressure is inaccurate because the intracranial pressure does rise and very markedly during sleep, particularly during the REM phase of sleep. What is no longer so well known is because of such significant increases in intracranial pressure occur. One possible explanation would be that obstructive sleep apnea causes increased intracranial pressure. But it remains to be clarified whether all patients with adult chronic hydrocephalus have sleep apnea, the mechanism of action, and to what extent the treatment of hydrocephalus acts on sleep apnea and vice versa.
Another aspect to consider is that the cerebrospinal fluid shunts work by the pressure gradient between the intracranial cavity and the cavity into which the cephalo-spinal fluid is drained66, usually the peritoneal fluid. During sleep apnea, there should be an increase in intra-abdominal pressure, which would result in the ventricle-peritoneal and lumbo-peritoneal shunts working suboptimally precisely at the time of day when they are most needed, that is when intracranial pressure increases. But this correlation has never been investigated or at least there are no publications about it.
Therefore, it is necessary to know the relationship between intracranial pressure, sleep apnea, and intra-abdominal pressure at night. With these data, it will be possible to better understand the dynamics of the circulation of the cerebrospinal fluid during the night (when it is more pathological in chronic hydrocephalus in adults), what type of bypass valve is the most indicated (whether or not it must have an anti-system siphon if it must be a gravitational or flow valve) and in which patients the implantation of a ventricle-atrial shunt may be an option to consider.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Normal Pressure Hydrocephalus, Sleep Apnea, Cerebrospinal Fluid Shunt Occlusion
Keywords
Normal pressure hydrocephalus, Sleep apnea, CSF shunt diversion, Ventriculo-peritoneal shunt, Ventriculo-atrial shunt
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Patients diagnosed of normal-pressure hydrocephalus will undergo sleep studies to rule our sleep apnea. Those with sleep apnea will be treated for this condition and we will see if the hydrocephalus symptoms improve
Masking
Participant
Masking Description
Patients will not be informed of the final treatment decided
Allocation
Non-Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Normal-pressure hydrocephalus only
Arm Type
Experimental
Arm Description
Patients suffering from normal-pressure hydrocephalus with NO sleep apnea
Arm Title
Normal-pressure hydrocephalus with sleep apnea
Arm Type
Active Comparator
Arm Description
Patients suffering from normal-pressure hydrocephalus with sleep apnea
Intervention Type
Procedure
Intervention Name(s)
CSF shunt diversion
Intervention Description
Clinical response to a CSF shunt insertion
Primary Outcome Measure Information:
Title
Change of hydrocephalus symptoms with Mini-Mental State Examination
Description
Patients will be evaluated with the Mini_mental State Examination before and after CSF shunting to see the degree of improvement they get from this surgical treatment
Time Frame
1-2 months
Title
Change of hydrocephalus symptoms with NPH scale after CSF shunt diversion
Description
Patients will be evaluated with the NPH before and after CSF shunting to see the degree of improvement they get from this surgical treatment
Time Frame
1-2 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Clinical condition compatible with normal-pressure hydrocephalus
Exclusion Criteria:
Cerebral vascular disease
Dementia not due to normal-pressure hydrocephalus
Parkinson's disease
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Vicente Vanaclocha
Phone
34669790013
Ext
438500
Email
vvanaclo@hotmail.com
Facility Information:
Facility Name
Vicente Vanaclocha
City
Valencia
ZIP/Postal Code
46015
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vicente Vanaclocha Vanaclocha, Prof MD PhD
Phone
669790013
Email
vvanaclo@hotmail.com
First Name & Middle Initial & Last Name & Degree
Vicente Vanaclocha Vanaclocha
Phone
669790013
Email
vvanaclo@hotmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
30640151
Citation
Kawada T. Obstructive sleep apnea in patients with idiopathic normal-pressure hydrocephalus. J Neurol Sci. 2019 Feb 15;397:155. doi: 10.1016/j.jns.2019.01.006. Epub 2019 Jan 10. No abstract available.
Results Reference
background
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Normal Pressure Hydrocephalus and Sleep Apnea
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