Effects of Nasal Airflow on Sleep in Tracheotomized Patients (Nasa)

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.

Study Overview

• Status: Recruiting
• Conditions: Patients With Prolonged Weaning
• Intervention / Treatment: Other: nasal oxygenation device

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.

• Study Type: Observational
• Enrollment (Estimated): 24

Contacts and Locations

• Study Contact: Name: MARTIN DRES, MD, PhD; Phone Number: 0142167809; Email: martin.dres@aphp.fr

Study Locations

• France
  • Paris, France, 75013
    • Recruiting
    • Pitie Salpetriere Hospital
    • Contact: MARTIN DRES, MD, PhD; Phone Number: 0142167809; Email: martin.dres@aphp.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Probability Sample

Study Population

Mechanically ventilated tracheotomized patients admitted for ventilation weaning.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with prolonged weaning; Mechanically ventilated tracheotomized patients admitted for ventilation weaning.	Other: nasal oxygenation device; Use of the nasal oxygenation device on one of the two nights during which polysomnography will be performed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effects of nasal ventilation on sleep quality in ventilation-dependent tracheostomized patients.	The proportion of time spent in REM sleep over the total sleep time	During the 12 hours duration of PSG

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effects of nasal ventilation on sleep duration	Total sleep time as determined by polysomnography	During the 12 hours duration of PSG
Effects of nasal ventilation on sleep architecture	Proportion of time spent in stage 1, stage 2 and stage 3 sleeping	During the 12 hours duration of PSG
Effects of nasal ventilation on the proportion of atypical sleep	Proportion of time spent in atypical sleep	During the 12 hours duration of PSG
Effects of nasal ventilation on minute ventilation	Measurement of transcutaneous PaCO2	During the 12 hours duration of PSG
Effects of nasal ventilation on night-time awakenings	Prevalence of night-time awakenings	During the 12 hours duration of PSG
Effects of nasal ventilation on patient-ventilator asynchrony	Asynchrony index (number of asynchronies/total number of respiratory cycles)	During the 12 hours duration of PSG

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start (Actual): April 10, 2025
• Primary Completion (Estimated): April 13, 2026
• Study Completion (Estimated): April 13, 2026

Study Registration Dates

• First Submitted: August 7, 2024
• First Submitted That Met QC Criteria: August 7, 2024
• First Posted (Actual): August 9, 2024

Study Record Updates

• Last Update Posted (Actual): July 3, 2025
• Last Update Submitted That Met QC Criteria: June 30, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: sleep; tracheostomy; nasal airflow
• Other Study ID Numbers: APHP240636

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

The procedures carried out with the French data privacy authority (CNIL, Commission nationale de l'informatique et des libertés) do not provide for the transmission of the database, nor do the information and consent documents signed by the patients.

Consultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations.

• IPD Sharing Time Frame: Beginning 3 months and ending 3 years following article publication. Requests out of these time frame can also be submitted to the sponsor
• IPD Sharing Access Criteria: Researchers who provide a methodologically sound proposal
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No