Sleep apnea and how it affects shunts in normal-pressure hydrocephalus
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
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Valencia Academic / other |
| Locations | 1 site (Valencia, Valencia) |
| Trial ID | NCT04471740 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Valencia, Valencia
- Vicente Vanaclocha — Valencia, Valencia, Spain (Recruiting)
Study contacts
- Study coordinator: Vicente Vanaclocha
- Email: vvanaclo@hotmail.com
- Phone: 34669790013
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.