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NCT Number: NCT06547463

Effects of Nasal Airflow on Sleep in Tracheotomized Patients

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Pitié Salpétrière HOSPITAL

Paris, 75013, France

Location status: Recruiting

Location contact

MARTIN DRES, MD, PhD

CONTACT

[email protected]

0142167809

About this study

The use of invasive mechanical ventilation via an endotracheal tube or tracheotomy involves bypassing the nasopharyngeal space and abolishing nasal ventilation. The first consequence is the loss of olfactory function. This function is quickly recovered when nasal ventilation is made possible. However, the abolition of nasal ventilation may have consequences beyond the loss of olfaction. The abolition of nasal ventilation in intubated rats inhibits these rhythmic oscillations, which can be restored by nasal sprays. In humans, nasal ventilation induces cerebral activity in functional brain areas and is associated with better cognitive performance compared to oral ventilation. In a model of intubated and ventilated rats, it has been shown that nasal sprays synchronized with the ventilator reduce hippocampal lesions compared to animals ventilated with an endotracheal tube without nasal sprays. Finally, in patients intubated with an endotracheal tube for toxic comas, the same nasal spray system restored brain activity and neural connectivity.

The aim of this study is to test the effects of nasal airflow of the sleep in tracheostomized patients who are still dependent to invasive mechanical ventilation. Patients will be investigated by a full polysomnography during two consecutive nights, with and without nasal airflow on the top of invasive mechanical ventilation, the two nights being randomized.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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

Treatment and study plan

nasal oxygenation device

Other

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

Primary outcomes

  1. Effects of nasal ventilation on sleep quality in ventilation-dependent tracheostomized patients.

    Time frame: During the 12 hours duration of PSG

    The proportion of time spent in REM sleep over the total sleep time

Secondary outcomes

  1. Effects of nasal ventilation on sleep duration

    Time frame: During the 12 hours duration of PSG

    Total sleep time as determined by polysomnography

  2. Effects of nasal ventilation on sleep architecture

    Time frame: During the 12 hours duration of PSG

    Proportion of time spent in stage 1, stage 2 and stage 3 sleeping

  3. Effects of nasal ventilation on the proportion of atypical sleep

    Time frame: During the 12 hours duration of PSG

    Proportion of time spent in atypical sleep

  4. Effects of nasal ventilation on minute ventilation

    Time frame: During the 12 hours duration of PSG

    Measurement of transcutaneous PaCO2

  5. Effects of nasal ventilation on night-time awakenings

    Time frame: During the 12 hours duration of PSG

    Prevalence of night-time awakenings

  6. Effects of nasal ventilation on patient-ventilator asynchrony

    Time frame: During the 12 hours duration of PSG

    Asynchrony index (number of asynchronies/total number of respiratory cycles)

Study contacts

Contact information is provided by the study sponsor or research team.

Martin Dres, MD, PhD

CONTACT

[email protected]

0142167809

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Acronym: Nasa

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 9, 2024
Registry last updated
Jul 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.