Normal Pressure Hydrocephalus and Sleep Apnea

NCT04471740 | Recruiting

• 1 other identifier: 2020-07-02
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Normal Pressure Hydrocephalus; Sleep Apnea; Cerebrospinal Fluid Shunt Occlusion

Keywords

Normal pressure hydrocephalus; Sleep apnea; CSF shunt diversion; Ventriculo-peritoneal shunt; Ventriculo-atrial shunt

Outcome Measures

Primary Outcomes (2)

• Change of hydrocephalus symptoms with Mini-Mental State Examination

  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

  1-2 months

• Change of hydrocephalus symptoms with NPH scale after CSF shunt diversion

  Patients will be evaluated with the NPH before and after CSF shunting to see the degree of improvement they get from this surgical treatment

  1-2 months

Study Arms (2)

Normal-pressure hydrocephalus only

EXPERIMENTAL

Patients suffering from normal-pressure hydrocephalus with NO sleep apnea

Procedure: CSF shunt diversion

Normal-pressure hydrocephalus with sleep apnea

ACTIVE COMPARATOR

Patients suffering from normal-pressure hydrocephalus with sleep apnea

Procedure: CSF shunt diversion

Interventions

CSF shunt diversion PROCEDURE

Clinical response to a CSF shunt insertion

Normal-pressure hydrocephalus only; Normal-pressure hydrocephalus with sleep apnea

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical condition compatible with normal-pressure hydrocephalus

You may not qualify if:

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

Sponsors & Collaborators

• University of Valencia: lead

Study Sites (1)

Vicente Vanaclocha

Valencia, Valencia, 46015, Spain

RECRUITING

Related Publications (1)

• Kawada T. Obstructive sleep apnea in patients with idiopathic normal-pressure hydrocephalus. J Neurol Sci. 2019 Feb 15;397:155. doi: 10.1016/j.jns.2019.01.006. Epub 2019 Jan 10. No abstract available.

  PMID: 30640151 BACKGROUND

MeSH Terms

Conditions

Hydrocephalus, Normal Pressure; Sleep Apnea Syndromes

Condition Hierarchy (Ancestors)

Hydrocephalus; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders

Central Study Contacts

Vicente Vanaclocha

CONTACT

34669790013; vvanaclo@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Patients will not be informed of the final treatment decided
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Model Details: Patients diagnosed of normal-pressure hydrocephalus will undergo sleep studies to rule our sleep apnea. Those with sleep apnea will be treated for this condition and we will see if the hydrocephalus symptoms improve

Study Record Dates

• First Submitted: July 3, 2020
• First Posted: July 15, 2020
• Study Start: July 2, 2020
• Primary Completion (Estimated): March 1, 2029
• Study Completion (Estimated): December 1, 2029
• Last Updated: April 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)