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Normal Pressure Hydrocephalus and Sleep Apnea

Study acronym: NPH/OSA
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary completion date: Jul 2, 2023 to Mar 2029
    • Study completion date: Dec 31, 2023 to Dec 2029
    • Site details revised
    v5
  2. Primary completion date: Jul 2, 2022 to Jul 2, 2023
    • Study completion date: Dec 31, 2022 to Dec 31, 2023
    v4
  3. 2 versions Re-verified since Jul 16, 2020, no change to tracked fieldsv2-v3
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT04471740
Lead Sponsor University of Valencia
Conditions
(from sponsor)		 Normal Pressure Hydrocephalus, Sleep Apnea, Cerebrospinal Fluid Shunt Occlusion
Related terms Hydrocephalus, Normal Pressure, Sleep Apnea Syndromes
Enrollment 30 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov