Effects of Nasal Airflow on Sleep in Tracheotomized Patients

NCT ID: NCT06547463

Last Updated: 2025-07-03

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 24 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-04-10
• Study Completion Date: 2026-04-13

Brief 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.

Detailed Description

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.

Conditions

Patients With Prolonged Weaning

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Patients with prolonged weaning

Mechanically ventilated tracheotomized patients admitted for ventilation weaning.

nasal oxygenation device

Intervention Type: OTHER

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

Interventions

nasal oxygenation device

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Pitié Salpétrière HOSPITAL

Paris, Paris, France

Site Status: RECRUITING

Countries

France

Central Contacts

Martin Dres, MD, PhD

Role: CONTACT

martin.dres@aphp.fr

0142167809

Facility Contacts

MARTIN DRES, MD, PhD

Role: primary

martin.dres@aphp.fr

0142167809

Other Identifiers

APHP240636

Identifier Type: -

Identifier Source: org_study_id