Effects of Nasal Airflow on Sleep in Tracheotomized Patients (NCT06547463) | Clinical Trial Compass
RecruitingNot Applicable
Effects of Nasal Airflow on Sleep in Tracheotomized Patients
France24 participantsStarted 2025-04-10
Plain-language 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 associated with better cognitive performance compared to oral breathing. Consequently, the abolition of nasal ventilation - intrinsic in tracheotomized and ventilated patients - could have deleterious effects on brain activity. Besides the loss of olfaction, the abolition of nasal ventilation could affect brain activity and sleep.
The hypothesis of the present study is that the restoration of nasal stimulation by the passage of humidified nasal airflow in tracheotomized and ventilated patients improves sleep quality, notably with a greater proportion of time spent in REM sleep.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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 criteria
✕. 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
What they're measuring
1
Effects of nasal ventilation on sleep quality in ventilation-dependent tracheostomized patients.