deltatrials
Active Not Recruiting PHASE3 INTERVENTIONAL 1-arm NCT04801771

Effects of Hypoglossal Nerve Stimulation on Cognition and Language in Down Syndrome and Obstructive Sleep Apnea

Sponsor: Inspire Medical Systems, Inc.

Conditions Down Syndrome Obstructive Sleep Apnea
Interventions Inspire Upper Airway Stimulation (UAS) System
Updated 12 times since 2021 Last updated: Sep 17, 2025 Started: Jun 24, 2021 Primary completion: Feb 28, 2027 Completion: Sep 30, 2027
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A PHASE3 clinical study on Down Syndrome and Obstructive Sleep Apnea, this trial is ongoing. The trial is conducted by Inspire Medical Systems, Inc. and has accumulated 12 data snapshots since 2021. Longitudinal tracking of this trial contributes to a broader understanding of treatment development timelines.

Status Flow

~Apr 2021 – ~Sep 2021 · 5 months · monthly snapshotNot Yet Recruiting~Sep 2021 – ~May 2022 · 8 months · monthly snapshotRecruiting~May 2022 – ~Sep 2022 · 4 months · monthly snapshotRecruiting~Sep 2022 – ~May 2023 · 8 months · monthly snapshotRecruiting~May 2023 – ~Apr 2024 · 11 months · monthly snapshotRecruiting~Apr 2024 – ~May 2024 · 30 days · monthly snapshotRecruiting~May 2024 – ~Jul 2024 · 2 months · monthly snapshotRecruiting~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotRecruiting~Sep 2024 – ~Oct 2024 · 30 days · monthly snapshotRecruiting~Oct 2024 – ~Jan 2025 · 3 months · monthly snapshotRecruiting~Jan 2025 – ~Oct 2025 · 9 months · monthly snapshotRecruiting~Oct 2025 – present · 9 months · monthly snapshotActive Not Recruiting

Change History

12 versions recorded

  1. Oct 2025 — Present [monthly]

    Active Not Recruiting PHASE3

    Status: Recruiting → Active Not Recruiting

  2. Jan 2025 — Oct 2025 [monthly]

    Recruiting PHASE3

  3. Oct 2024 — Jan 2025 [monthly]

    Recruiting PHASE3

  4. Sep 2024 — Oct 2024 [monthly]

    Recruiting PHASE3

  5. Jul 2024 — Sep 2024 [monthly]

    Recruiting PHASE3

▶ Show 7 earlier versions

  1. May 2024 — Jul 2024 [monthly]

    Recruiting PHASE3

  2. Apr 2024 — May 2024 [monthly]

    Recruiting PHASE3

    Phase: PHASE2 → PHASE3

  3. May 2023 — Apr 2024 [monthly]

    Recruiting PHASE2

  4. Sep 2022 — May 2023 [monthly]

    Recruiting PHASE2

  5. May 2022 — Sep 2022 [monthly]

    Recruiting PHASE2

  6. Sep 2021 — May 2022 [monthly]

    Recruiting PHASE2

    Status: Not Yet Recruiting → Recruiting

  7. Apr 2021 — Sep 2021 [monthly]

    Not Yet Recruiting PHASE2

    First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Inspire Medical Systems, Inc.
  • National Institute on Deafness and Other Communication Disorders (NIDCD)
  • National Institutes of Health (NIH)
Data source: Inspire Medical Systems, Inc.

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations