Change in Sleep Breathing During Hospital Admission for COPD Exacerbation

NCT07361744 | Active Not Recruiting DMC

• 1 other identifier: 2024-A02121-46
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

COPD Acute Exacerbation

Keywords

sleep; breathing variability

Outcome Measures

Primary Outcomes (1)

• Nocturnal ventilatory variability during sleep assessed by polysomnography

  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.

  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)

Secondary Outcomes (5)

• Nocturnal ventilatory variability assessed by a non-contact respiratory sensor

  Nightly during hospitalization (up to 7 days) and during one overnight recording at 6 weeks after hospital discharge

• Correlation between nocturnal ventilatory variability and clinical worsening during hospitalization

  From baseline (first night after hospitalization) through Day 7 of hospitalization or the day before discharge (maximum hospitalization duration: 7 days)

• Correlation between nocturnal ventilatory variability and physician-assessed readiness for hospital discharge

  Daily from baseline (first night after hospitalization) until hospital discharge (up to 7 days)

• Association between nocturnal ventilatory variability and 28-day hospital readmission

  Up to 28 days after hospital discharge

• Correlation between nocturnal ventilatory variability and daytime ventilatory drive assessed by parasternal electromyography

  Day 1, Day 3, Day 7 (or the night before discharge if discharge occurs earlier), and 6 weeks after hospital discharge.

Study Arms (1)

COPD acute exacerbations

Consecutive patients admitted in a medicine hospital department for acute exacerbation of COPD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study population consists of adult patients with a confirmed diagnosis of chronic obstructive pulmonary disease (COPD) who are hospitalized for an acute exacerbation. Eligible participants are included within the first 24 hours of admission to an acute medical ward and are able to provide informed consent. All participants have COPD diagnosed by spirometry according to standard criteria and are admitted for management of an exacerbation not requiring invasive or non-invasive mechanical ventilation at the time of inclusion. Patients receiving long-term positive airway pressure therapy or home non-invasive ventilation are excluded. The study population reflects a real-life hospitalized COPD cohort, encompassing a range of disease severity, clinical trajectories, and comorbidities commonly observed during acute exacerbations. Participants are followed during hospitalization and up to six weeks after discharge to characterize changes in nocturnal ventilatory patterns during recovery.

You may qualify if:

• Adults (≥ 18 years) with a confirmed diagnosis of chronic obstructive pulmonary disease (COPD) based on spirometry
• Admitted to an acute medical ward
• Able to provide written informed consent
• Affiliated with the national health insurance system

You may not qualify if:

• 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

Sponsors & Collaborators

• Asten Sante: lead
• Pitié-Salpêtrière Hospital: collaborator

Study Sites (1)

Pitié-Salpétrière Hospital

Paris, 75013, France

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2025
• First Posted: January 23, 2026
• Study Start: December 9, 2025
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: January 23, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF

Locations

FR (1)