Sleep Disorders Trial, Recruiting NCT07113288 Sponsor: Inspire Medical Systems, Inc. Condition: Sleep Disorders
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Sleep Disorders Trial, Recruiting

NCT07113288
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 aged 18 or older.
  • People who have been diagnosed with severe sleep apnoea (a specific severity score between 65 and 100) based on a sleep study done within the last 12 months, OR people diagnosed with moderate to severe sleep apnoea (a score between 15 and 100) who also have a BMI between 32 and 40.
  • People whose sleep apnoea was not adequately controlled by CPAP or similar breathing machines, or who were unable to tolerate using them (confirm with trial site for exact definitions).
  • People who are willing and able to have a device surgically implanted and to use a handheld remote to control it.
  • People who are able to attend follow-up visits, complete sleep studies (both in a clinic and at home), and fill out questionnaires.
  • People who are willing and able to give their formal written consent to participate.

Who may not be able to join:

  • People whose sleep apnoea includes a high proportion (more than 25%) of a specific type of breathing disruption called central or mixed apnoeas (confirm with trial site).
  • People with certain physical features in their airway that could prevent the device from working properly.
  • People who have a condition or have had a procedure that has affected the nerve control of their upper airway.
  • People who are unable to operate the handheld remote themselves and do not have someone available to assist them with it.
  • People who are pregnant or planning to become pregnant.
  • People who already have an implanted medical device that could interfere with the trial device.
  • People with a serious illness where life expectancy is less than 12 months.
  • People the trial doctor considers unsuitable for any other reason.

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 12 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: 763-392-9966

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
Inspire Medical Systems, Inc.
Registry
ClinicalTrials.gov
Start date
31 July 2025
Est. completion
1 January 2032

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Incidence of Procedure and/or Device Related Adverse Events (Safety and Tolerability)

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: 12 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