Status:
RECRUITING
Effects of Nasal Airflow on Sleep in Tracheotomized Patients
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Patients With Prolonged Weaning
Eligibility:
All Genders
18+ years
Brief Summary
The passage of air through the nasal cavities generates rhythmic oscillations transmitted by the olfactory bulb to the brain, which induces cerebral activation in functional brain areas and is associa...
Detailed Description
The use of invasive mechanical ventilation via an endotracheal tube or tracheotomy involves bypassing the nasopharyngeal space and abolishing nasal ventilation. The first consequence is the loss of ol...
Eligibility Criteria
Inclusion
- Age ≥ 18 years
- Admission to PRRS for weaning from ventilation
- Tracheotomy and nocturnal invasive mechanical ventilation
- Indication for polysomnography by care team
- Agreement to participate by patient or trusted person/relative and signature of consent form
- Affiliation with a social security scheme or beneficiary
Exclusion
- Diseases of the central nervous system: cerebrovascular accident (CVA), multiple sclerosis (MS), epilepsy
- Psychiatric illnesses (psychoses)
- Hyperthermia (temperature \> 38.5°C)
- Agitation, resuscitation delirium
- Continuous use of sedatives
- Patients under legal protection (guardianship/curatorship)
- Patients deprived of liberty by judicial or administrative decision
- Patients under AME
- Pregnant or breast-feeding women
Key Trial Info
Start Date :
April 10 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
April 13 2026
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT06547463
Start Date
April 10 2025
End Date
April 13 2026
Last Update
July 3 2025
Active Locations (1)
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1
Pitié Salpétrière HOSPITAL
Paris, Paris, France, 75013