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Effects of Nasal Airflow on Sleep in Tracheotomized Patients

Recruitingn/aAges 18 Years - anyAllAssistance Publique - Hôpitaux de Paris
NCT06547463 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. Age ≥ 18 years 2. Admission to PRRS for weaning from ventilation 3. Tracheotomy and nocturnal invasive mechanical ventilation 4. Indication for polysomnography by care team 5. Agreement to participate by patient or trusted person/relative and signature of consent form 6. Affiliation with a social security scheme or beneficiary Exclusion Criteria: 1. Diseases of the central nervous system: cerebrovascular accident (CVA), multiple sclerosis (MS), epilepsy 2. Psychiatric illnesses (psychoses) 3. Hyperthermia (temperature \> 38.5°C) 4. Agitation, resuscitation delirium 5. Continuous use of sedatives 6. Patients under legal protection (guardianship/curatorship) 7. Patients deprived of liberty by judicial or administrative decision 8. Patients under AME 9. Pregnant or breast-feeding women
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What it tests

  • nasal oxygenation device
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Where

1 site
Pitié Salpétrière HOSPITAL
Paris, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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