Ireland
--:--IST
Recruiting Not applicable

Normal Pressure Hydrocephalus and Sleep Apnea

NCT04471740 · tracked via the Priya Life Science Spain tracker
Phase
Not applicable
Started
2020-07-02
Last updated
2026-04-22

Condition(s) studied

Normal Pressure HydrocephalusSleep ApneaCerebrospinal Fluid Shunt Occlusion

Investigational drug(s) / intervention(s)

CSF shunt diversion

CSF shunt diversion: Clinical response to a CSF shunt insertion

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Clinical condition compatible with normal-pressure hydrocephalus Exclusion Criteria: * Cerebral vascular disease * Dementia not due to normal-pressure hydrocephalus * Parkinson's disease

Primary outcome measure(s)

  • Change of hydrocephalus symptoms with Mini-Mental State Examination — 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 — 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

Trial sites (1)

FacilityCityRegionStatus
Vicente Vanaclocha Valencia Valencia Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04471740 on ClinicalTrials.gov ↗ ← All trials in Spain