Normal Pressure Hydrocephalus and Sleep Apnea

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Valencia

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Clinical condition compatible with normal-pressure hydrocephalus

Disqualifiers

Cerebral vascular disease

Dementia not due to normal-pressure hydrocephalus

Parkinson's disease

Trial design

Design model

Single group

Treatments tested in this trial

  • CSF shunt diversion

    Procedure/Surgery

    Clinical response to a CSF shunt insertion

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: Normal-pressure hydrocephalus onlyExperimental treatment 1 intervention
Group B: Normal-pressure hydrocephalus with sleep apneaActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
1-2 months
2

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

Time frame
1-2 months

Secondary outcomes

Other outcomes

Sponsors and contacts

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