Sleep Disorders Trial, Recruiting NCT06332404 Sponsor: University Hospital, Antwerp Condition: Sleep Disorders
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Sleep Disorders Trial, Recruiting

NCT06332404
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 are at least 18 years old at the time of receiving the device implant
  • People who have moderate to severe obstructive sleep apnoea, meaning their breathing interruptions during sleep fall within a specific measured range (between 15 and 65 events per hour)
  • People who have tried and not been able to use, or are not suitable for, CPAP (a breathing machine used during sleep) and/or a mandibular advancement device (a mouth device worn during sleep)
  • People who have had a specific sleep-related airway assessment (called Drug-Induced Sleep Endoscopy, or DISE) showing that a particular type of airway collapse is not present
  • People who have already received the Inspire hypoglossal nerve stimulation (HNS) device, or are receiving it, and are able to give their informed consent to participate

Who may not be able to join:

  • People with a Body Mass Index (BMI) above 32 kg/m² (a measure of body weight relative to height)
  • People whose sleep apnoea events are made up of more than 25% mixed or central type breathing interruptions (rather than the obstructive type)
  • People who, during the DISE assessment, show a specific pattern of airway collapse at the soft palate, or have any other structural airway feature that could prevent the device from working properly
  • People who have severely reduced nerve-related control over the muscles in the upper airway
  • People who are pregnant
  • People who have had surgery on the soft palate within the three months before the implant procedure

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 20 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: Olivier Vanderveken, MD, PhD, University Hospital, Antwerp

Phone: +3238215780

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
University Hospital, Antwerp
Registry
ClinicalTrials.gov
Start date
18 April 2024
Est. completion
1 April 2034

Where this trial is recruiting

🇧🇪 Belgium

Primary endpoints

Delta apnea-hypopnea index (AHI) as measured by a polysomnography

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: 20 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