Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID04471740

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

Led by University of Valencia · Updated on 2026-04-22

30

Participants Needed

1

Research Sites

39 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Normal-pressure hydrocephalus is a condition in adults characterized by symptoms like gait problems, urinary incontinence, and dementia. This condition is linked to increased intracranial pressure during sleep, especially in relation to obstructive sleep apnea. Researchers are studying how sleep apnea affects intracranial and intra-abdominal pressures and how these pressures influence cerebrospinal fluid (CSF) shunting treatments. The study aims to determine the best type of shunt and drainage location to improve treatment outcomes and understand the interaction between sleep apnea and hydrocephalus symptoms. The study compares patients with normal-pressure hydrocephalus who have sleep apnea to those who do not. All participants receive a CSF shunt diversion procedure, where fluid is drained from the brain to either the abdominal cavity or the heart. Researchers will analyze pressure changes during sleep and sleep apnea episodes to decide which shunt type and drainage site are most effective. The study will also evaluate whether treating sleep apnea improves hydrocephalus symptoms. Participants will undergo assessments measuring changes in hydrocephalus symptoms using the Mini-Mental State Examination and the NPH scale within 1 to 2 months after CSF shunt insertion. The study monitors intracranial and intra-abdominal pressures during sleep, particularly during apnea episodes. This monitoring helps understand CSF flow dynamics at night and guides decisions on the type of shunt valve and drainage location. The total study duration and follow-up details are based on these evaluations to assess symptom changes and treatment impact.

CONDITIONS

Brief Title

Normal Pressure Hydrocephalus and Sleep Apnea

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Clinical condition compatible with normal-pressure hydrocephalus
Not Eligible

You will not qualify if you...

  • Cerebral vascular disease
  • Dementia not due to normal-pressure hydrocephalus
  • Parkinson's disease

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 1 to 2 months

Participants receive a cerebrospinal fluid (CSF) shunt insertion to treat normal-pressure hydrocephalus and its symptoms.

1 baseline visit and follow-up visits during 1 to 2 months after shunt insertion

Trial Site Locations

Total: 1 location

1

Vicente Vanaclocha

Valencia, Valencia, Spain, 46015

Actively Recruiting

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Research Team

V

Vicente Vanaclocha

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

NON_RANDOMIZED

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

2

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