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Clinical Trials in France / NCT06547463
Recruiting Observational

Effects of Nasal Airflow on Sleep in Tracheotomized Patients

NCT06547463 · tracked via the Priya Life Science France tracker
Sponsor
Assistance Publique - Hôpitaux de Paris
Phase
Observational
Started
2025-04-10
Last updated
2025-07-03

Condition(s) studied

Patients With Prolonged Weaning

Investigational drug(s) / intervention(s)

nasal oxygenation device

nasal oxygenation device: Use of the nasal oxygenation device on one of the two nights during which polysomnography will be performed.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Effects of nasal ventilation on sleep quality in ventilation-dependent tracheostomized patients. — During the 12 hours duration of PSG
    The proportion of time spent in REM sleep over the total sleep time

Trial sites (1)

FacilityCityRegionStatus
Pitié Salpétrière HOSPITAL Paris Paris Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06547463 on ClinicalTrials.gov ↗ ← All trials in France