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Can a nighttime breathing machine ease severe COPD?

NCT ID NCT07198880

Disease control Sponsor: Assiut University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether using a BiPAP breathing machine at home can help people with severe COPD who have high carbon dioxide levels. Forty adults will use the machine nightly for a year while continuing standard medications. Researchers will track blood gas levels, breathing symptoms, and quality of life to see if home ventilation makes a difference.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
BiPAP device (non-invasive ventilation)
What this could lead to
If it works, this could show that using a breathing machine at home helps people with severe COPD breathe easier and feel better day-to-day.
What could go wrong
This is a small, early-stage study with only 40 people, so results may not apply to everyone. The device can be uncomfortable, and some people may not use it enough to see benefits.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 40 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jan 2026

An estimate. Start dates often move.

Expected to finish

Jan 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Patients more than 18 year old. * Severe COPD (classified as GOLD stage Ⅲ and IV), confirmed by FEV₁/FVC \< 70% and FEV₁ \< 50% of the predicted value. (9) * Persistent hypercapnia (PaCO₂ ≥ 60 mmHg ≥2 weeks after resolution of acute exacerbation and compliant on optimal medical therapy with or without long term oxygen therapy Exclusion Criteria: * Other significant respiratory disorders (e.g,history suggestive OSA, Body Mass Index more than 30, pneumothorax, bullous lung disease, advanced interstitial lung diseases , restrictive thoracic wall diseases , neuromuscular disease). * Undergone intubation or tracheostomy prior to NIV initiation during the last 2 months. * Those using addictive narcotic medications. * Comorbidities and diseases that might confound survival outcomes (e.g., malignancy, advanced hepatic or renal diseases). * Pregnancy * Refusal or Inability to tolerate NIV during initiation and adaptation phase. * Expected Poor compliance (patients deemed unlikely to adhere to nightly NIV use such as no family support, severe frailty). * Withdrawal criteria: stopping bipap or medical treatment, voluntary withdrawal by the participant, failure to attend scheduled visits, and significant clinical deterioration requiring alternative management during the study period

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Conditions

The condition(s) this trial relates to.

chronic obstructive pulmonary disease COPD, severe early onset Hypercapnia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

BIPAP COPD COPD (chronic obstructive pulmonary disease) Hypercapnia Long term oxygen therapy Non invasive ventilation (NIV) Ventilation therapy

How to take part

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  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  2. A doctor treating you

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