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Effects of Nasal Airflow on Sleep in Tracheotomized Patients

Effects of Nasal Airflow on Sleep in Tracheotomized Patients

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06547463
Acronym
Nasa
Enrollment
24
Registered
2024-08-09
Start date
2025-04-10
Completion date
2026-04-13
Last updated
2025-07-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients With Prolonged Weaning

Keywords

tracheostomy, sleep, nasal airflow

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.

Interventions

OTHERnasal oxygenation device

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

Sponsors

Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

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

Design outcomes

Primary

MeasureTime frameDescription
Effects of nasal ventilation on sleep quality in ventilation-dependent tracheostomized patients.During the 12 hours duration of PSGThe proportion of time spent in REM sleep over the total sleep time

Secondary

MeasureTime frameDescription
Effects of nasal ventilation on sleep architectureDuring the 12 hours duration of PSGProportion of time spent in stage 1, stage 2 and stage 3 sleeping
Effects of nasal ventilation on the proportion of atypical sleepDuring the 12 hours duration of PSGProportion of time spent in atypical sleep
Effects of nasal ventilation on sleep durationDuring the 12 hours duration of PSGTotal sleep time as determined by polysomnography
Effects of nasal ventilation on night-time awakeningsDuring the 12 hours duration of PSGPrevalence of night-time awakenings
Effects of nasal ventilation on patient-ventilator asynchronyDuring the 12 hours duration of PSGAsynchrony index (number of asynchronies/total number of respiratory cycles)
Effects of nasal ventilation on minute ventilationDuring the 12 hours duration of PSGMeasurement of transcutaneous PaCO2

Countries

France

Contacts

Primary ContactMartin Dres, MD, PhD
martin.dres@aphp.fr0142167809

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026