Sleep Disorders Trial, Recruiting (NCT06851338)

Sleep Disorders Trial, Recruiting NCT06851338 Sponsor: Inspire Medical Systems, Inc. Condition: Sleep Disorders

Printed from Voxsanity (voxsanity.com.au) — NCT06851338 — 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 person has been diagnosed with Down syndrome
The person is between 13 and 18 years old
The person has been diagnosed with severe obstructive sleep apnea, confirmed by a sleep study done in a clinic within the last 6 months, with a specific sleep apnea score (AHI) between 10 and 50
The person has tried breathing support devices worn during sleep (such as CPAP or BiPAP) but was unable to tolerate them or they did not work, even after efforts to improve use
The person is not a suitable candidate for, or was not helped by, surgery to remove the tonsils and adenoids
All other standard treatment options for sleep apnea have been considered for the person
The person and their parent or guardian are willing to have a device permanently implanted and to attend follow-up visits, complete further sleep studies in a clinic, and fill out questionnaires

Who may not be able to join:

The person's recent sleep study shows that more than 25% of their sleep apnea events are a type called central or mixed apneas (confirm with trial site)
The person has a physical feature in their airway that could stop the device from working properly, such as a specific type of airway collapse involving the soft palate
The person has a condition or has had a procedure that affects how the nerves controlling the upper airway work
The person, or their parent or guardian, is unable to operate the device's remote control and does not have someone to help them do so
The person is pregnant or plans to become pregnant
The person already has an implanted device that could interfere with the trial device (called the Inspire system)
The person is likely to need a type of medical scan called an MRI that falls outside the specific safety guidelines for this device
The person has a serious illness where life expectancy is less than 12 months
The trial investigator has any other reason to consider the person unsuitable for the study

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 7 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

Phone: 763.392.7222

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: NCT06851338

Sponsor: Inspire Medical Systems, Inc.

Phase: Not Applicable

Status: Recruiting

Condition: Sleep Disorders

Trial contact: 763.392.7222

More information: https://clinicaltrials.gov/study/NCT06851338

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 person has been diagnosed with Down syndrome
The person is between 13 and 18 years old
The person has been diagnosed with severe obstructive sleep apnea, confirmed by a sleep study done in a clinic within the last 6 months, with a specific sleep apnea score (AHI) between 10 and 50
The person has tried breathing support devices worn during sleep (such as CPAP or BiPAP) but was unable to tolerate them or they did not work, even after efforts to improve use
The person is not a suitable candidate for, or was not helped by, surgery to remove the tonsils and adenoids
All other standard treatment options for sleep apnea have been considered for the person
The person and their parent or guardian are willing to have a device permanently implanted and to attend follow-up visits, complete further sleep studies in a clinic, and fill out questionnaires

Who may not be able to join:

The person's recent sleep study shows that more than 25% of their sleep apnea events are a type called central or mixed apneas (confirm with trial site)
The person has a physical feature in their airway that could stop the device from working properly, such as a specific type of airway collapse involving the soft palate
The person has a condition or has had a procedure that affects how the nerves controlling the upper airway work
The person, or their parent or guardian, is unable to operate the device's remote control and does not have someone to help them do so
The person is pregnant or plans to become pregnant
The person already has an implanted device that could interfere with the trial device (called the Inspire system)
The person is likely to need a type of medical scan called an MRI that falls outside the specific safety guidelines for this device
The person has a serious illness where life expectancy is less than 12 months
The trial investigator has any other reason to consider the person unsuitable for the study

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 7 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

Inspire Medical Systems, Inc.

Registry

ClinicalTrials.gov

Start date

1 February 2025

Est. completion

1 May 2030

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Safety Outcome Measure - Procedure and Device-related Adverse events; Effectiveness Outcome Measure - Comparison of Baseline and Annual Apnea-Hypopnea Index (AHI)

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: 7 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