Sleep Disorders Trial, Recruiting NCT06030349 Sponsor: Children's Health Ireland Condition: Sleep Disorders
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Sleep Disorders Trial, Recruiting

NCT06030349
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 have a confirmed diagnosis of Down Syndrome and whose doctor has decided they need to start non-invasive breathing support (such as a CPAP or BiPAP mask-based device).
  • People whose sleep study results show more than 2 breathing interruptions per hour, or more than 1 breathing interruption per hour alongside other symptoms of disrupted sleep breathing.
  • People who can communicate and complete study materials in English.
  • People who are at least 4 months old at the time they start the therapy.

Who may not be able to join:

  • People who are not willing or able to follow the study's procedures and assessments.
  • People who are already using a prescribed breathing support device, or who have an artificial airway (such as a tracheostomy).
  • People who are currently taking part in another clinical trial testing an investigational therapy for breathing support.

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 23 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

Principal Investigator: Sheila Javadpour, Children's Health Ireland

Phone: 0035314282626

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
Children's Health Ireland
Registry
ClinicalTrials.gov
Start date
28 November 2022
Est. completion
28 November 2027

Where this trial is recruiting

🇮🇪 Ireland 🇬🇧 United Kingdom

Primary endpoints

To determine the effect of treatment of obstructive sleep apnoea syndrome with non-invasive ventilation on quality of life in children with Down Syndrome > 3 years.; To determine the effect of treatment of obstructive sleep apnoea syndrome with non-invasive ventilation on quality of life in children with Down Syndrome < 3 years.; To determine the effect of treatment of obstructive sleep apnoea syndrome with non-invasive ventilation on caregiver concerns regarding sleep disordered breathing for caregivers of children with Down Syndrome < 3 years.; To determine the effect of treatment of obstruc...

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: 23 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