Effects of Nasal Airflow on Sleep in Tracheotomized Patients

Recruiting now

Conditions studied: Patients With Prolonged Weaning

In brief

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.

Key facts

Study ID

NCT06547463

Run by

Assistance Publique - Hôpitaux de Paris

People needed

24

Starts

2025-04-10

Expected to finish

2026-04-13

Last updated by the study team

2025-07-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Pitié Salpétrière HOSPITAL — Paris, Paris, France (enrolling)

Full record on ClinicalTrials.gov

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