Sleep apnea and how it affects shunts in normal-pressure hydrocephalus
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
Run by University of Valencia · NCT04471740 · Data updated 2026-11-12
This project will measure intracranial and intra-abdominal pressures during sleep in people with normal-pressure hydrocephalus to see if sleep apnea affects shunt function and whether treating sleep apnea improves symptoms.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 30 (estimated) |
| Sponsor | University of Valencia Academic / other |
| Locations | 1 site (Valencia, Valencia) |
| Status | Recruiting |
| Started | July 2, 2020 |
| Main results expected | March 2029 |
| Study ends | December 2029 |
| Registry record updated | April 22, 2026 |
| Trial ID | NCT04471740 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults with clinical normal-pressure hydrocephalus being considered for CSF shunting who do not have cerebrovascular disease, dementia from other causes, or Parkinson's disease.
✕Probably not a fit
Patients whose symptoms are primarily due to cerebrovascular disease, non‑NPH dementia, or Parkinson's disease, or those without sleep apnea, are unlikely to benefit from the study's findings.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This interventional protocol records intracranial and intra-abdominal pressures overnight in patients with normal-pressure hydrocephalus, focusing on changes during apneic episodes. The study compares pressure dynamics relevant to distal drainage into the peritoneum versus the right atrium and relates those findings to shunt patency and clinical outcomes. The protocol may include addressing obstructive sleep apnea and following patients to see whether OSA treatment changes symptoms and shunt performance. Key exclusions (cerebrovascular disease, non-NPH dementia, Parkinson's disease) are applied to reduce confounding.
Why it matters
Potential benefit: If successful, the findings could help surgeons choose the best shunt destination (peritoneum versus atrium) and show that treating sleep apnea reduces shunt occlusion and improves gait, continence, and cognition.
How similar studies have gone: Prior research shows intracranial pressure rises during sleep and with obstructive sleep apnea, but using overnight pressure monitoring to guide shunt destination and link OSA treatment with improved NPH outcomes is relatively novel and not yet well established.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Vicente Vanaclocha
Valencia, Valencia, Spain Recruiting
Study contacts
- Study coordinator: Vicente Vanaclocha
- Email: vvanaclo@hotmail.com
- Phone: 34669790013
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.