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Simple breathing device may speed recovery from a deadly sickle cell complication

NCT ID NCT07703566

Disease control Sponsor: Assistance Publique - Hôpitaux de Paris Source: ClinicalTrials.gov ↗

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 14, 2026 · Last updated Jul 24, 2026 · Updated 3 times

Summary

This trial investigates whether continuous positive airway pressure (CPAP) can help adults with sickle cell disease recover faster from acute chest syndrome, a serious lung complication. Participants who need extra oxygen are randomly assigned to receive either standard oxygen alone or oxygen plus CPAP for at least 6 hours a day. The study measures how quickly symptoms like fever, chest pain, and low oxygen levels resolve.

What this could mean

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

Active substance
Continuous positive airway pressure (CPAP), a non-invasive breathing support device that delivers a steady stream of air to keep the airways open
What this could lead to
If effective, CPAP could become a standard, low-cost treatment to speed recovery from acute chest syndrome and reduce the need for intensive care in sickle cell disease.
What could go wrong
This is a relatively small trial, and earlier studies of other breathing support methods have not shown clear benefits. CPAP may not improve outcomes or could be poorly tolerated by some patients.

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 140 people

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

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Dec 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 years and older

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: * SCD patient of all genotypes (SS, SC, S/β0 and S/β+) * Age ≥ 18 years old * Hospitalised for ACS (defined as the association of fever and/or acute respiratory symptoms with a new pulmonary infiltrate on chest imaging) * Requiring supplemental O2 ≥ 2 L/min for SpO2 ≥ 95% * Informed consent from the patient * Affiliated to a social security regime Exclusion Criteria: * Patient having both ACS criteria and need for supplemental O2 ≥ 2 L/min for SpO2 ≥ 95% since more than 48 hours * Requirement for home supplemental O2 or home CPAP / NIV. * Signs of worsening respiratory failure mandating intubation (as defined in (Helms et al., 2024)) * Current enrolment in another interventional research concerning a respiratory support during ACS * Known legal incapacity (patients under guardianship or curatorship) * Exacerbation of asthma, chronic obstructive pulmonary disease or another known or suspected chronic respiratory disease * Absolute contraindications to CPAP, including any of the following: patient not cooperating or opposing the technique, pneumothorax not drained, chest wound blowing, uncontrollable vomiting, upper gastrointestinal bleeding, craniofacial trauma, severe upper airway obstruction, traumatic tetraplegia at the initial phase, cardiac arrest, shock (need for vasopressor), or Coma Glasgow scale \<12. * Known pregnancy, breast feeding, women with childbearing potential will be tested for pregnancy and excluded if pregnant,

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Conditions

The condition(s) this trial relates to.

acute chest syndrome sickle cell disease

As listed by the trial registrant

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

Acute chest syndrome (ACS) Sickle cell disease (SCD) Sickle cell disease (SCD) patient hospitalised for acute chest syndrome (ACS) requiring supplemental oxygen

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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