Clinical Trial

Normal Pressure Hydrocephalus and Sleep Apnea

Study acronym: NPH/OSA
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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.
Protocol Amendment History 4 amendments
This ClinicalTrials.gov record has been amended 4 times since 2020-07-14; most recent amendment 2026-04-18.
Trial Details
NCT Number NCT04471740
Lead Sponsor University of Valencia
Conditions Normal Pressure Hydrocephalus, Sleep Apnea, Cerebrospinal Fluid Shunt Occlusion
Enrollment 30 participants
Start Date 2020-07-02
Primary Completion 2029-03 (estimated)
Study Completion 2029-12 (estimated)
Updated on ClinicalTrials.gov 2026-04-22