Patients With Prolonged WeaningNasaNCT06547463
Effects of Nasal Airflow on Sleep in Tracheotomized Patients
An observational study of Patients With Prolonged Weaning, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patients With Prolonged Weaning
- What is being tested?
- nasal oxygenation device
- How many people
- 24 participants
- Where
- 1 siteFrance
- Study dates
- 10 Apr 2025to 13 Apr 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Mechanically ventilated tracheotomized patients admitted for ventilation weaning.
Who may be able to join
- 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
Who cannot join
- 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)
Show all 9Show fewer
- Patients deprived of liberty by judicial or administrative decision
- Patients under AME
- Pregnant or breast-feeding women
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Pitié Salpétrière HOSPITAL
Paris, Paris, 75013
MARTIN DRES, MD, PhD, 0142167809, martin.dres@aphp.fr
About this study
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.
Read the 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
- Being tested
- nasal oxygenation device
- Keywords
- tracheostomy, sleep, nasal airflow
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nasal oxygenation deviceOther
Use of the nasal oxygenation device on one of the two nights during which polysomnography will be performed.
| Study group | Role | What they receive |
|---|---|---|
| Patients with prolonged weaning | Mechanically ventilated tracheotomized patients admitted for ventilation weaning. Receives: Other: nasal oxygenation device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: During the 12 hours duration of PSG
Secondary outcomes (6)
Effects of nasal ventilation on sleep duration
Total sleep time as determined by polysomnography
Measured: 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
Measured: During the 12 hours duration of PSG
Effects of nasal ventilation on the proportion of atypical sleep
Proportion of time spent in atypical sleep
Measured: During the 12 hours duration of PSG
Effects of nasal ventilation on minute ventilation
Measurement of transcutaneous PaCO2
Measured: During the 12 hours duration of PSG
Effects of nasal ventilation on night-time awakenings
Prevalence of night-time awakenings
Measured: 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)
Measured: During the 12 hours duration of PSG
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2024
- Study start10 Apr 2025
- Primary completion13 Apr 2026 (estimated)
- Study completion13 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients With Prolonged WeaningStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06547463
- Sponsor's protocol ID
- APHP240636
- Acronym
- Nasa
- Status last verified
- Jun 2025
- First submitted
- 7 Aug 2024
- Last updated
- 3 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Nasal Airflow on Sleep in Tracheotomized Patients
- ClinicalTrials.gov ID
- NCT06547463
- Acronym / sponsor ID
- Nasa / APHP240636
- Conditions
- Patients With Prolonged Weaning
- Keywords
- tracheostomy, sleep, nasal airflow
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 10 Apr 2025 (actual)
- Primary completion
- 13 Apr 2026 (estimated)
- Study completion
- 13 Apr 2026 (estimated)
- First posted
- 9 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with prolonged weaning | – | Other: nasal oxygenation deviceMechanically ventilated tracheotomized patients admitted for ventilation weaning. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Mechanically ventilated tracheotomized patients admitted for ventilation weaning.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| nasal oxygenation deviceUse of the nasal oxygenation device on one of the two nights during which polysomnography will be performed. | Other | Patients with prolonged weaning |
Primary outcome
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
6 secondary outcomes
Effects of nasal ventilation on sleep duration
Time frame: During the 12 hours duration of PSG
Effects of nasal ventilation on sleep architecture
Time frame: During the 12 hours duration of PSG
Effects of nasal ventilation on the proportion of atypical sleep
Time frame: During the 12 hours duration of PSG
Effects of nasal ventilation on minute ventilation
Time frame: During the 12 hours duration of PSG
Effects of nasal ventilation on night-time awakenings
Time frame: During the 12 hours duration of PSG
Effects of nasal ventilation on patient-ventilator asynchrony
Time frame: During the 12 hours duration of PSG
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2025.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Patients With Prolonged Weaning, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Martin Dres, MD, PhD (0142167809, martin.dres@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effects of nasal ventilation on sleep quality in ventilation-dependent tracheostomized patients. (time frame: During the 12 hours duration of PSG). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2025.