Who is sponsoring NCT04801771?

NCT04801771 is sponsored by Inspire Medical Systems, Inc..

What drugs are being tested in NCT04801771?

Interventions in NCT04801771: Inspire Upper Airway Stimulation (UAS) System.

What condition does NCT04801771 study?

NCT04801771 studies Down Syndrome, Obstructive Sleep Apnea.

Is NCT04801771 still recruiting?

NCT04801771 is currently active, enrolled. Last updated 18 September 2025.

Last reviewed 2025-09-18 · How we verify

NCT04801771

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Active, enrolled Phase 3 Last updated 18 September 2025

What this trial tests

Phase 3 trial testing Inspire Upper Airway Stimulation (UAS) System in Down Syndrome in 57 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

24 June 2021

Primary endpoint
28 February 2027

30 September 2027

Quick facts

Lead sponsor	Inspire Medical Systems, Inc.
Phase	Phase 3
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	57
Start date	24 June 2021
Primary completion	28 February 2027
Estimated completion	30 September 2027
Sites	8 locations across United States

Drugs / interventions tested

Inspire Upper Airway Stimulation (UAS) System

Conditions studied

Down Syndrome — all drugs for Down Syndrome →
Obstructive Sleep Apnea — all drugs for Obstructive Sleep Apnea →

Sponsor

Inspire Medical Systems, Inc. — full company profile →

Who can join

Adults 10 to 21, any sex, with Down Syndrome or Obstructive Sleep Apnea. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Aging with Down Syndrome-Where Are We Now and Where Are We Going?
Alldred MJ, Martini AC, Patterson D, Hendrix J, et al · · 2021 · cited 29× · PMID 34682809 · DOI 10.3390/jcm10204687

Verify or expand the search:

Other recruiting trials for Down Syndrome

Currently open trials in the same condition.

NCT07416201 — Natural History of Dysregulation and Aging of the Immune System in People With Trisomy 21 With and Without Thymectomy · recruiting
NCT07484464 — Effects of the Otago Exercise Program on Balance, Endurance, and Motor Coordination in Children With Down Syndrome · NA · recruiting
NCT07428863 — Effects of Jump Rope on Navicular Drop in Down Syndrome · NA · recruiting
NCT07260136 — Cervical Spine Abnormalities in Down Syndrome · active not recruiting
NCT07248449 — Physical Fitness in DS: A Comparison of Cuevas Medak and Rebound Exercises · NA · recruiting

Other Inspire Medical Systems, Inc. trials

Trials by the same sponsor.

NCT07113288 — Inspire UAS High Apnea Hypopnea Index (AHI)/High Body Mass Index (BMI) Post-Approval Study · recruiting
NCT05428839 — The PREDICTOR Study: Assessing Diagnostic Predictors of Airway Collapse in Patients With Obstructive Sleep Apnea · NA · unknown
NCT04416542 — Inspire Home Study: Utilization of Home Monitoring During Therapy Optimization in Patients With an Inspire Upper Airway · NA · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04801771 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Inspire Medical Systems, Inc.
Last refreshed: 18 September 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04801771.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing