Actively Recruiting

Age: 18Years +
All Genders
NCT06547463

Effects of Nasal Airflow on Sleep in Tracheotomized Patients

Led by Assistance Publique - Hôpitaux de Paris · Updated on 2025-07-03

24

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Effects of Nasal Airflow on Sleep in Tracheotomized Patients

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • 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
Not Eligible

You will not qualify if you...

  • Diseases of the central nervous system such as cerebrovascular accident, multiple sclerosis, or epilepsy
  • Psychiatric illnesses including psychoses
  • Hyperthermia with temperature above 38.5°C
  • Agitation or resuscitation delirium
  • Continuous use of sedatives
  • Patients under legal protection (guardianship or curatorship)
  • Patients deprived of liberty by judicial or administrative decision
  • Patients under AME
  • Pregnant or breast-feeding women

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Pitié Salpétrière HOSPITAL

Paris, Paris, France, 75013

Actively Recruiting

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Research Team

M

Martin Dres, MD, PhD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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Effects of Nasal Airflow on Sleep in Tracheotomized Patients | DecenTrialz