Normal Pressure HydrocephalusNPH/OSANCT04471740
Normal Pressure Hydrocephalus and Sleep Apnea
A study testing CSF shunt diversion in people with Normal Pressure Hydrocephalus and Sleep Apnea, run by University of Valencia at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Normal Pressure Hydrocephalus, Sleep Apnea, Cerebrospinal Fluid Shunt Occlusion
- What is being tested?
- CSF shunt diversion
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSpain
- Study dates
- 2 Jul 2020to Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical condition compatible with normal-pressure hydrocephalus
Who cannot join
- Cerebral vascular disease
- Dementia not due to normal-pressure hydrocephalus
- Parkinson's disease
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Vicente Vanaclocha
Valencia, Valencia, 46015
Vicente Vanaclocha Vanaclocha, Prof MD PhD, 669790013, vvanaclo@hotmail.com
Vicente Vanaclocha Vanaclocha, 669790013, vvanaclo@hotmail.com
About this study
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
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.
Read the 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.
- Being tested
- CSF shunt diversion
- Keywords
- Normal pressure hydrocephalus, Sleep apnea, CSF shunt diversion, Ventriculo-peritoneal shunt, Ventriculo-atrial shunt
- Medical subject headings
- Hydrocephalus, Normal Pressure, Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CSF shunt diversionProcedure or surgery
Clinical response to a CSF shunt insertion
| Study group | Role | What they receive |
|---|---|---|
| Normal-pressure hydrocephalus only | Experimental | Patients suffering from normal-pressure hydrocephalus with NO sleep apnea Receives: Procedure: CSF shunt diversion |
| Normal-pressure hydrocephalus with sleep apnea | Active comparator | Patients suffering from normal-pressure hydrocephalus with sleep apnea Receives: Procedure: CSF shunt diversion |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1-2 months
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
Measured: 1-2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2020
- Study start2 Jul 2020
- Primary completionMar 2029 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Normal Pressure HydrocephalusStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Valencia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vicente Vanaclocha, University of Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04471740
- Sponsor's protocol ID
- 2020-07-02
- Acronym
- NPH/OSA
- Status last verified
- Apr 2026
- First submitted
- 3 Jul 2020
- Last updated
- 22 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 30640151
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04471740
- Acronym / sponsor ID
- NPH/OSA / 2020-07-02
- Keywords
- Normal pressure hydrocephalus, Sleep apnea, CSF shunt diversion, Ventriculo-peritoneal shunt, Ventriculo-atrial shunt
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Study start
- 2 Jul 2020 (actual)
- Primary completion
- Mar 2029 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 15 Jul 2020 (actual)
- 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| Normal-pressure hydrocephalus only | Experimental | Procedure: CSF shunt diversionPatients suffering from normal-pressure hydrocephalus with NO sleep apnea |
| Normal-pressure hydrocephalus with sleep apnea | Active comparator | Procedure: CSF shunt diversionPatients suffering from normal-pressure hydrocephalus with sleep apnea |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Clinical condition compatible with normal-pressure hydrocephalus
Key exclusion criteria (3 listed)
- Cerebral vascular disease
- Dementia not due to normal-pressure hydrocephalus
- Parkinson's disease
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 |
|---|---|---|
| CSF shunt diversionClinical response to a CSF shunt insertion | Procedure or surgery | Normal-pressure hydrocephalus only, Normal-pressure hydrocephalus with sleep apnea |
Primary outcome
Change of hydrocephalus symptoms with Mini-Mental State Examination
Time frame: 1-2 months
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
Time frame: 1-2 months
Patients will be evaluated with the NPH before and after CSF shunting to see the degree of improvement they get from this surgical treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2026.
- Background: PubMed 30640151Kawada 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.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CSF shunt diversion in people with Normal Pressure Hydrocephalus and Sleep Apnea, run by University of Valencia at 1 site in Spain.
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 1 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 22 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Vicente Vanaclocha (34669790013 ext. 438500, vvanaclo@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of hydrocephalus symptoms with Mini-Mental State Examination (time frame: 1-2 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04471740, which also lists 1 linked publication.
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 22 Apr 2026.