Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04801771 · ClinicalTrials.gov registry record · Phase 3
Effects of Hypoglossal Nerve Stimulation on Cognition and Language in Down Syndrome and Obstructive Sleep Apnea
A Phase 3 study of Obstructive Sleep Apnea and Down Syndrome, sponsored by Inspire Medical Systems.
- Active
- Registry status
- Phase 3
- Development phase
- 57
- Enrollment target
- 8
- Study locations
NCT04801771: Active Phase 3 study of Obstructive Sleep Apnea and Down Syndrome, sponsored by Inspire Medical Systems.
NCT04801771 is a Phase 3 study of Obstructive Sleep Apnea and Down Syndrome that is active but no longer recruiting, run by Inspire Medical Systems. The registered enrollment target is 57 participants, below the 221-participant average among 155 other Obstructive Sleep Apnea trials with a reported enrollment target (74% lower). The trial reports 8 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04801771, a Phase 3 study of Obstructive Sleep Apnea and Down Syndrome, is active but no longer recruiting, sponsored by Inspire Medical Systems.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 57 participants
- Enrollment target
- 8
- Study locations
Study Summary
This study is a prospective, single-arm study conducted under a common implant and follow-up protocol. The objective will be to follow fifty-seven (57) adolescents and young adults (10-21 years of age), with Down syndrome, moderate to severe sleep apnea, and post-adenotonsillectomy, for 12 months after undergoing implant of the Inspire Upper Airway Stimulation (UAS) System. The study is being conducted in order to evaluate objective change in cognition and expressive language after implant and therapy with the Inspire UAS System.
Primary Outcome
Change in the Intelligence Quotient Standard Score of at least 0.5 standard deviation from baseline
Conditions Studied
Interventions
- DEVICE Inspire Upper Airway Stimulation (UAS) System
Study Locations (8)
Pennsylvania
- Children's Hospital of Philadelphia - Philadelphia
- Children's Hospital of Pittsburgh - Pittsburgh
Georgia
- Children's Healthcare of Atlanta/ Emory University School of Medicine - Atlanta
Massachusetts
- Massachusetts General Hospital (Mass Eye & Ear Infirmary) - Boston
Ohio
- Cincinnati Childrens Hospital - Cincinnati
Texas
- University of Texas Southwestern/Children's Hospital of Dallas - Dallas
Virginia
- Children's Hospital of the King's Daughters/East Virginia Medical School - Norfolk
Wisconsin
- University of Wisconsin School of Medicine and Public Health - Madison
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 57 participants |
| Start Date | 2021-06-24 |
| Est. Completion | 2027-09-30 |
| Phase | Phase 3 |
What the registry record for NCT04801771 still lists
NCT04801771 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 57 participants, a relatively small participant target, below the 221-participant average among 155 other Obstructive Sleep Apnea trials with a reported enrollment target (74% lower).
The record links to 2 conditions, with Obstructive Sleep Apnea appearing as the primary indexed condition, and to 1 intervention - of which Inspire Upper Airway Stimulation (UAS) System is the first listed.
NCT04801771 lists 8 locations in 7 states (Pennsylvania, Georgia, Massachusetts).
Frequently Asked Questions
What is clinical trial NCT04801771 about?
NCT04801771 is a clinical study titled "Effects of Hypoglossal Nerve Stimulation on Cognition and Language in Down Syndrome and Obstructive Sleep Apnea". This study is a prospective, single-arm study conducted under a common implant and follow-up protocol. The objective will be to follow fifty-seven (57) adolescents and young adults (10-21 years of age), with Down syndrome, moderate to severe sleep apnea, and post-adenotonsillectomy, for 12 months af...
What is the current status of trial NCT04801771?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 57 participants. The study started on 2021-06-24. Estimated completion is 2027-09-30.
What conditions does trial NCT04801771 study?
This clinical trial studies the following conditions: Obstructive Sleep Apnea, Down Syndrome.
What interventions are being tested in trial NCT04801771?
The interventions under investigation include: Inspire Upper Airway Stimulation (UAS) System (DEVICE).
Who is sponsoring clinical trial NCT04801771?
This trial is sponsored by Inspire Medical Systems, which has 8 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04801771 being conducted?
This trial has 8 study locations across Georgia, Massachusetts, Ohio, Pennsylvania, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Obstructive Sleep Apnea
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04801771's enrollment target sits among peer trials
57 98th of 155 higher than 57 of 155 other Obstructive Sleep Apnea trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Obstructive Sleep Apnea trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Maridebart Cafraglutide Versus Placebo in Adult Participants With Obstructive Sleep Apnea Not on Positive Airway Pressure (PAP) Therapy
RECRUITING · Phase 3
-
Maridebart Cafraglutide Versus Placebo in Adult Participants With Obstructive Sleep Apnea on Positive Airway Pressure Therapy
RECRUITING · Phase 3
-
A Study of Retatrutide (LY3437943) in Participants Who Have Obesity or Overweight
ACTIVE NOT RECRUITING · Phase 3
-
A Study of Retatrutide (LY3437943) in Participants With Type 2 Diabetes Mellitus Who Have Obesity or Overweight
ACTIVE NOT RECRUITING · Phase 3
-
Effect of Heated Humidity With Thermosmart™ Compared to an Intranasal Steroid in Improving Compliance and Nasal Symptoms in Patients Using Continuous Positive Airway Pressure
COMPLETED · Phase 3
-
PMP-300E (Smart Watch): Portable Monitoring Device Study
COMPLETED · Phase 3
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03521830 · 57 participants · Phase 2
Nivolumab Alone or Plus Relatlimab or Ipilimumab for Patients With Locally-Advanced Unresectable or Metastatic Basal Cell Carcinoma
- NCT03587701 · 57 participants · Phase 2
Effects of Anakinra in Subjects With Corticosteroid-resistant/Intolerant Meniere's Disease and Autoimmune Inner Ear Disease
- NCT04104126 · 57 participants · NA
Blood Flow Restriction Therapy in Achilles Injury
- NCT04703842 · 57 participants · Phase 1
Modulation of SERCA2a of Intra-myocytic Calcium Trafficking in Heart Failure With Reduced Ejection Fraction
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI