Treating Obstructive Sleep Apnea Using Targeted Hypoglossal Neurostimulation

NCT04950894 | Completed DMC FDA Device

• 1 other identifier: LNS005
• Study Type: interventional
• Target: 107
• Locations: 1 country
• Sites: 19

Brief Summary

Multi-center, open-label, prospective, randomized clinical trial of the aura6000(R) System for the reduction of apnea and hypopneas in adult patients with moderate to severe obstructive sleep apnea who have failed or are unwilling to use positive airway pressure treatment.

Conditions

Obstructive Sleep Apnea; OSA; Apnea; Apnea, Obstructive; Apnea, Obstructive Sleep; Apnea+Hypopnea; Hypopnea, Sleep

Keywords

OSA; Snoring; Obstructive Sleep Apnea; CPAP; PAP

Outcome Measures

Primary Outcomes (2)

• Rate of response to therapy when compared to no therapy for 6 months

  The primary efficacy endpoint is to demonstrate that the AHI responder rate of subjects with the device stimulation activated (Active Group) is statistically significantly higher than the AHI responder rate of subjects with the device stimulation not activated (Control Group) at M7.

  Month 1 through Month 7

• Rate of all serious adverse device/procedure related events from time of implant through month 7

  The primary safety endpoint is a descriptive evaluation of all reported serious adverse device/procedure related events (SADEs) through M7 for both groups. Relationship to procedure, device and study will be adjudicated by a Clinical Events Committee (CEC).

  Month 1 through Month 7

Secondary Outcomes (8)

• Decrease in Oxygen Desaturation Index (Efficacy)

  Baseline through Month 7

• Change in Functional Outcomes of Sleep Questionnaire (Efficacy

  Baseline through Month 7

• Change in Epworth Sleepiness Scale (Efficacy)

  Baseline through Month 7

• Change in EQ-5D (Efficacy)

  Baseline through Month 7

• Change in PROMIS SDI/SRI (Efficacy)

  Baseline through Month 7

Study Arms (2)

Active

ACTIVE COMPARATOR

HGN therapy activation at Month 1 - compared at Month 7 to Control group, continued stimulation through Month 13

Device: Hypoglossal Nerve Stimulation

Control

OTHER

HGN therapy NOT activated at Month 1 - compared at Month 7 to Active group, stimulation will start at Month 7 + 1 Day and continue through Month 13

Device: Hypoglossal Nerve Stimulation

Interventions

Hypoglossal Nerve Stimulation DEVICE

Hypoglossal Nerve Stimulation started at Month 1 compared to no Stimulation (Control group will start stimulation at M7+1Day)

Active; Control

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of moderate to severe OSA
• Declines to use or does not tolerate PAP therapy

You may not qualify if:

• Respiratory, cardiac, renal disease or other co-morbid conditions
• BMI \> 35 kg/m2
• Specific PSG criteria outlined in the protocol

Sponsors & Collaborators

• LivaNova: lead

Study Sites (19)

University of Alabama At Birmingham

Birmingham, Alabama, 35294, United States

Location

University of Arizona

Tucson, Arizona, 85724, United States

Location

Sacramento Ent

Roseville, California, 95661, United States

Location

Paul Schalch Lepe, Md/Silenso Clinic

San Diego, California, 92130, United States

Location

Sleep Medicine Specialists of South Florida

Miami, Florida, 33126, United States

Location

Morton Plant Mease Health Care

Safety Harbor, Florida, 34695, United States

Location

Advanced Ent Associates

Atlanta, Georgia, 30342, United States

Location

Norton Healthcare

Louisville, Kentucky, 40218, United States

Location

Alivation Research Llc

Lincoln, Nebraska, 68526, United States

Location

Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

Location

Weill Cornell Medical College

New York, New York, 10024, United States

Location

Raleigh Neurology Associates, Pa

Raleigh, North Carolina, 27607, United States

Location

Penn State Health

Hershey, Pennsylvania, 17033, United States

Location

Lankenau Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Bogan Sleep Consultants, Llc

Columbia, South Carolina, 29201, United States

Location

Houston Methodist

Houston, Texas, 77030, United States

Location

Epic Medical Research

Red Oak, Texas, 75154, United States

Location

University of Utah

Salt Lake City, Utah, 84108, United States

Location

Related Publications (2)

• Malhotra A, Schwartz AR, Lovett E, Juran N, Nguyen SA, Barrera JE, Bogan RK, Mickelson SA, Boghara H, Miller M, Jacobowitz O; OSPREY Investigators. Proximal Hypoglossal Nerve Stimulation for Obstructive Sleep Apnea in the OSPREY Study : A Randomized Controlled Trial. Ann Intern Med. 2026 Jun;179(6):812-822. doi: 10.7326/ANNALS-25-04414. Epub 2026 Apr 21.

  PMID: 42008810 DERIVED

• Jacobowitz O, Schwartz AR, Lovett EG, Ranuzzi G, Malhotra A. Design and rationale for the treating Obstructive Sleep Apnea using Targeted Hypoglossal Nerve Stimulation (OSPREY) trial. Contemp Clin Trials. 2022 Aug;119:106804. doi: 10.1016/j.cct.2022.106804. Epub 2022 May 22.

  PMID: 35613672 DERIVED

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Apnea; Sleep Apnea Syndromes; Snoring

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Respiratory Sounds

Study Officials

• Atul Malhotra, MD

  UCSD Pulmonary and Critical Care Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: PSG results are masked from the Investigator and Outcomes Assessor.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: All subjects are implanted and randomized. Stimulation treatment started at M1 for the Active group and M7 +1day for the Control group. Both groups followed through M13. Additionally, the long-term phase allows for continued collection of data for safety, efficacy, and quality of life for up to four years from the time the subject completes the final M13 visit.

Study Record Dates

• First Submitted: June 18, 2021
• First Posted: July 6, 2021
• Study Start: February 24, 2022
• Primary Completion: October 17, 2024
• Study Completion: April 23, 2025
• Last Updated: July 17, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (19)