Sleep Disorders Trial, Recruiting NCT05958563 Sponsor: University Hospital, Angers Condition: Sleep Disorders
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Sleep Disorders Trial, Recruiting

NCT05958563
Recruiting Not Applicable

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People who are 40 years of age or older
  • People whose breathlessness is rated at grade 2 or higher on a standard 0–4 breathlessness scale, meaning at least some limitation to daily activities due to shortness of breath
  • People whose lung function tests show reduced airflow, specifically a post-inhaler FEV1 (a measure of how much air can be blown out in one second) below 70% of the expected value, and an FEV1/FVC ratio below 0.70 (confirm with trial site if unsure about your test results)
  • People with a confirmed record of at least one moderate or severe COPD flare-up in the past year
  • People whose answers to a standard sleep questionnaire suggest a possibility of obstructive sleep apnoea (a score above 3 on the STOP-Bang questionnaire)
  • People who have access to a telephone or tablet, or who are willing to use one during the study
  • People who are willing and able to follow all study procedures
  • People who are covered by, or entitled to, medical care insurance
  • People whose overnight sleep study shows 15 or more breathing pauses per hour and fewer than 5 central (brain-signal-related) apnoeas per hour of sleep

Who may not be able to join:

  • People with severe daytime sleepiness, including a score above 14 out of 24 on the Epworth Sleepiness Scale, frequent sleepiness while driving, or a near-accident due to falling asleep at the wheel in the past 12 months
  • People with serious, unstable heart or cardiovascular conditions, such as heart failure with reduced pumping function (FEVG 45% or below), recurring irregular heartbeat, unstable coronary artery disease, or recent stroke
  • People currently using long-term oxygen therapy or a breathing support machine (non-invasive ventilation)
  • People with a previously recorded high level of carbon dioxide in the blood (PaCO2 at or above 50 mmHg)
  • People who have already been diagnosed with and are receiving treatment for obstructive sleep apnoea
  • People who have a lung rehabilitation programme or lung volume reduction procedure planned within the coming year
  • People who are pregnant or breastfeeding
  • People who do not have a sufficient understanding of the French language
  • People who fall under certain protected categories as defined by French public health law (confirm with trial site for details)

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 20 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Phone: +33680575272

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Not Applicable
Sponsor
University Hospital, Angers
Registry
ClinicalTrials.gov
Start date
9 January 2024
Est. completion
1 January 2028

Where this trial is recruiting

🇫🇷 France

Primary endpoints

annual rate of COPD exacerbations

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 20 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov