Phase 4 Sleep Disorders Trial, Recruiting (NCT06576830)

Phase 4 Sleep Disorders Trial, Recruiting NCT06576830 Sponsor: Duke University Condition: Sleep Disorders

Printed from Voxsanity (voxsanity.com.au) — NCT06576830 — 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:

Children aged 3 years old up to (but not including) 18 years old
Children scheduled for a planned tonsil removal, with or without adenoid removal
A parent or legal guardian has signed a consent form on the child's behalf
Children aged 12 and older must also sign a written consent form themselves, and children aged 7 and older must verbally agree to participate
Girls who have gone through puberty must have had a negative pregnancy test within 48 hours before joining

Who may not be able to join:

Children with a history of long-term kidney or liver disease
Children who have been diagnosed with an ongoing chronic pain condition
Children for whom a stay in the Pediatric Intensive Care Unit (a specialist ward for seriously ill children) is already planned after surgery
Children who are having other procedures done at the same time under general anaesthetic that would normally require strong pain-relief medication (opioids)

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

Phase 4 trials study a drug that has already been approved, monitoring long-term safety and effectiveness in real-world use.

Contact this trial

Principal Investigator: Lisa M. Einhorn, MD, Duke University

Phone: 9196814877

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: NCT06576830

Sponsor: Duke University

Phase: Phase 4

Status: Recruiting

Condition: Sleep Disorders

Trial contact: 9196814877

More information: https://clinicaltrials.gov/study/NCT06576830

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:

Children aged 3 years old up to (but not including) 18 years old
Children scheduled for a planned tonsil removal, with or without adenoid removal
A parent or legal guardian has signed a consent form on the child's behalf
Children aged 12 and older must also sign a written consent form themselves, and children aged 7 and older must verbally agree to participate
Girls who have gone through puberty must have had a negative pregnancy test within 48 hours before joining

Who may not be able to join:

Children with a history of long-term kidney or liver disease
Children who have been diagnosed with an ongoing chronic pain condition
Children for whom a stay in the Pediatric Intensive Care Unit (a specialist ward for seriously ill children) is already planned after surgery
Children who are having other procedures done at the same time under general anaesthetic that would normally require strong pain-relief medication (opioids)

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 23 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

Phase 4

Sponsor

Duke University

Registry

ClinicalTrials.gov

Start date

21 November 2024

Est. completion

31 December 2028

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Number of participants who required rescue opioid administration in the PACU (post-anesthesia care unit)

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