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Clinical Trials in France / NCT07361744
Active, not recruiting Observational

Change in Sleep Breathing During Hospital Admission for COPD Exacerbation

NCT07361744 · tracked via the Priya Life Science France tracker
Sponsor
Asten Sante
Phase
Observational
Started
2025-12-09
Last updated
2026-01-23

Condition(s) studied

COPD Acute Exacerbation

Study summary

hronic obstructive pulmonary disease (COPD) is a common lung disease that can worsen suddenly, leading to hospital admission. During these exacerbations, breathing becomes unstable and recovery is difficult to predict. Currently, doctors lack simple tools to monitor how patients recover day by day during hospitalization and after discharge.

This observational study aims to describe how breathing patterns during sleep change over time in patients hospitalized for a COPD exacerbation. Breathing will be monitored using standard sleep recordings and a non-contact sensor placed under the mattress, which measures breathing without disturbing the patient.

By better understanding how nocturnal breathing variability evolves during recovery, this study may help identify early signs of improvement or deterioration, support safer hospital discharge decisions, and improve follow-up after hospitalization for COPD exacerbation

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria * Adults (≥ 18 years) with a confirmed diagnosis of chronic obstructive pulmonary disease (COPD) based on spirometry * Hospitalized for an acute exacerbation of COPD for less than 24 hours at the time of inclusion * Admitted to an acute medical ward * Able to provide written informed consent * Affiliated with the national health insurance system Exclusion Criteria * Ongoing invasive or non-invasive mechanical ventilation at the time of inclusion * Long-term non-invasive ventilation or positive airway pressure therapy prior to hospitalization * Use of an anti-pressure (anti-decubitus) mattress incompatible with the study devices * Severe anxiety disorders interfering with study procedures * Known allergy to materials used for sensor placement * Pregnancy or breastfeeding * Minor or legally protected adult (guardianship, curatorship) or deprivation of liberty * Lack of health insurance coverage

Primary outcome measure(s)

  • Nocturnal ventilatory variability during sleep assessed by polysomnography — Baseline (first night after hospitalization), Day 3 of hospitalization, Day 7 of hospitalization or the day before discharge (if discharge occurs earlier), and 6 weeks after hospital discharge (study completion)
    Nocturnal ventilatory variability will be quantified during sleep using polysomnography. Variability will be assessed on a breath-by-breath basis using 30-second analysis windows and summarized by the following predefined indice SD. SD will be calculated separately for each sleep stage (N1, N2, N3, REM) and then averaged across total sleep time for each recording night.

Trial sites (1)

FacilityCityRegionStatus
Pitié-Salpétrière Hospital Paris France

More Asten Sante trials in France

Impact of Patient Involvement in Alerts Management of Telemonitoring CPAP Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07361744 on ClinicalTrials.gov ↗ ← All trials in France