Sleep Disorders Trial, Recruiting (NCT05508971)

Sleep Disorders Trial, Recruiting NCT05508971 Sponsor: Oregon Health and Science University Condition: Sleep Disorders

Printed from Voxsanity (voxsanity.com.au) — NCT05508971 — Data sourced from ClinicalTrials.gov. Verify directly with the trial site before attending. Not medical advice.

Back to Sleep Disorders

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:

The child has been diagnosed with Down syndrome (Trisomy 21)
The child has been diagnosed with moderate to severe obstructive sleep apnea (OSA), confirmed by a sleep study showing a specific level of breathing disruptions during sleep (oAHI of 5 or higher)
The child is between 2 and 17 years of age
The child's primary caregiver is 18 years of age or older and is able to sign and date a consent form
The child's primary caregiver is able to speak, read, and write in English or Spanish
The caregiver is the child's main caretaker
The child is not pregnant
The child has been assessed as suitable for surgical treatment by medical professionals

Who may not be able to join:

The child has previously had their tonsils fully or partially removed
The child has a medical condition that makes surgery unsafe, such as a bleeding disorder
The child has a significant heart or lung condition beyond OSA that requires extra oxygen support, or has narrowing of the airway, or depends on a breathing tube in the throat (tracheostomy)
The caregiver is unwilling or unable to follow the study procedures
The child is pregnant or planning to become pregnant

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 27 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: Derek Lam, MD, MPH, Oregon Health and Science University

Phone: 503-875-9895

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.

Voxsanity

Clinical trials and treatments, explained plainly · voxsanity.com.au

Date:

To: My Doctor

Re: Clinical trial enquiry

I am writing to enquire about the following clinical trial which may be relevant to my care:

Trial: NCT05508971

Sponsor: Oregon Health and Science University

Phase: Not Applicable

Status: Recruiting

Condition: Sleep Disorders

Trial contact: 503-875-9895

More information: https://clinicaltrials.gov/study/NCT05508971

Eligibility summary (AI generated)

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

The child has been diagnosed with Down syndrome (Trisomy 21)
The child has been diagnosed with moderate to severe obstructive sleep apnea (OSA), confirmed by a sleep study showing a specific level of breathing disruptions during sleep (oAHI of 5 or higher)
The child is between 2 and 17 years of age
The child's primary caregiver is 18 years of age or older and is able to sign and date a consent form
The child's primary caregiver is able to speak, read, and write in English or Spanish
The caregiver is the child's main caretaker
The child is not pregnant
The child has been assessed as suitable for surgical treatment by medical professionals

Who may not be able to join:

The child has previously had their tonsils fully or partially removed
The child has a medical condition that makes surgery unsafe, such as a bleeding disorder
The child has a significant heart or lung condition beyond OSA that requires extra oxygen support, or has narrowing of the airway, or depends on a breathing tube in the throat (tracheostomy)
The caregiver is unwilling or unable to follow the study procedures
The child is pregnant or planning to become pregnant

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

Access in Australia: A treatment being studied in a clinical trial is generally not yet listed on the PBS. Where a medicine is not approved or not available through a trial, the TGA Special Access Scheme may allow a doctor to access unapproved therapeutic goods for individual patients. See voxsanity.com.au/sas-navigator/ for a plain English explainer.

This information was sourced from ClinicalTrials.gov via Voxsanity (data last synced 27 July 2026). It is not medical advice. Please verify the trial's current status directly with the trial site before acting.

Trial details

Status

Recruiting

Phase

Not Applicable

Sponsor

Oregon Health and Science University

Registry

ClinicalTrials.gov

Start date

2 August 2023

Est. completion

31 December 2027

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Change from Baseline Polysomnography Measures: oAHI at 6 months; Change from Baseline Polysomnography Measures: AHI at 6 months; Change from Baseline Polysomnography Measures: REM AHI at 6 months; Change from Baseline Polysomnography Measures: min SpO2 at 6 months; Change from Baseline Polysomnography Measures: desat index at 6 months; Change from Baseline Polysomnography Measures: % Total Sleep Time with ETCO2 > 50 mmHg at 6 months; Change from Baseline Polysomnography Measures: Max End Tidal CO2 (ETCO2) at 6 months

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: 27 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