RecruitingNCT06547463

Effects of Nasal Airflow on Sleep in Tracheotomized Patients


Sponsor

Assistance Publique - Hôpitaux de Paris

Enrollment

24 participants

Start Date

Apr 10, 2025

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria6

  • 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 Criteria9

  • 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

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

OTHERnasal oxygenation device

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


Locations(1)

Pitié Salpétrière HOSPITAL

Paris, Paris, France

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06547463