Effects of nasal airflow on sleep in patients with tracheostomy
Effects of Nasal Airflow on Sleep in Tracheotomized Patients
This study is testing if using humidified nasal airflow can help improve sleep quality, especially REM sleep, in patients with tracheostomies who rely on mechanical ventilation.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 24 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 1 site (Paris, Paris) |
| Trial ID | NCT06547463 on ClinicalTrials.gov |
What this trial studies
This study investigates how nasal airflow affects sleep quality in patients who have undergone tracheostomy and are dependent on invasive mechanical ventilation. It aims to determine if the restoration of nasal ventilation through humidified airflow can improve sleep, particularly increasing the duration of REM sleep. Participants will undergo polysomnography over two nights, one with nasal airflow and one without, in a randomized manner to assess the differences in sleep quality. The study is based on previous findings that suggest nasal ventilation may enhance brain activity and cognitive performance.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who are tracheostomized and require nocturnal invasive mechanical ventilation for weaning.
Not a fit: Patients with central nervous system diseases, psychiatric illnesses, or those under legal protection may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve sleep quality and cognitive function in tracheostomized patients.
How similar studies have performed: Previous studies have shown promising results regarding the benefits of nasal ventilation on brain activity and cognitive performance, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Paris, Paris
- Pitié Salpétrière HOSPITAL — Paris, Paris, France (Recruiting)
Study contacts
- Study coordinator: Martin Dres, MD, PhD
- Email: martin.dres@aphp.fr
- Phone: 0142167809
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.