Treating Obstructive Sleep Apnea Using Targeted Hypoglossal Neurostimulation (OSPREY)

February 6, 2023 updated by: LivaNova
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

All qualifying subjects will be implanted. Subjects will be randomized 2:1 in favor of Stimulation therapy (Active Group). Randomization will occur following implant and prior to the Month 1 visit.

The Active group will start Stimulation therapy at Month 1. The Control group may continue with their current sleep apnea treatment until Month 7, and will receive Stimulation therapy beginning at Month 7 +1Day. (All subjects are excluded from use of PAP or surgical treatments after enrollment through Month 13)

Safety and efficacy will be evaluated at Month 7, and again at Month 13.

Study Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • Recruiting
        • University of Alabama At Birmingham
    • Arizona
      • Phoenix, Arizona, United States, 85006
        • Recruiting
        • Banner Health
      • Tucson, Arizona, United States, 85724
        • Recruiting
        • University of Arizona
    • California
      • Roseville, California, United States, 95661
        • Recruiting
        • Sacramento ENT
      • San Diego, California, United States, 92130
        • Recruiting
        • Paul Schalch Lepe, Md/Silenso Clinic
    • Florida
      • Miami, Florida, United States, 33126
        • Recruiting
        • Sleep Medicine Specialists of South Florida
      • Safety Harbor, Florida, United States, 34695
        • Recruiting
        • Morton Plant Mease Health Care
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Recruiting
        • Advanced Ent Associates
    • Kentucky
      • Louisville, Kentucky, United States, 40218
        • Recruiting
        • Norton Healthcare
    • Nebraska
      • Lincoln, Nebraska, United States, 68526
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Recruiting
        • Hackensack University Medical Center
    • New York
      • New York, New York, United States, 10024
    • North Carolina
      • Raleigh, North Carolina, United States, 27607
        • Recruiting
        • Raleigh Neurology Associates, PA
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
        • Recruiting
        • Penn State Health
      • Philadelphia, Pennsylvania, United States, 19107
        • Recruiting
        • Philadelphia Ear, Nose and Throat Associates
        • Contact:
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Recruiting
        • Medical University of South Carolina
      • Columbia, South Carolina, United States, 29201
        • Recruiting
        • Bogan Sleep Consultants, LLC
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • Houston Methodist
      • Red Oak, Texas, United States, 75154
        • Recruiting
        • Epic Medical Research
    • Utah
      • Salt Lake City, Utah, United States, 84108
        • Recruiting
        • University of Utah

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

22 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Abbreviated: Additional criteria may apply:

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Active
HGN therapy activation at Month 1 - compared at Month 7 to Control group, continued stimulation through Month 13
Device: Hypoglossal Nerve Stimulation
Hypoglossal Nerve Stimulation started at Month 1 compared to no Stimulation (Control group will start stimulation at M7+1Day)
OTHER: Control
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
Hypoglossal Nerve Stimulation started at Month 1 compared to no Stimulation (Control group will start stimulation at M7+1Day)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of response to therapy when compared to no therapy for 6 months
Time Frame: Month 1 through Month 7
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
Time Frame: Month 1 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 Outcome Measures

Outcome Measure
Time Frame
Decrease in Oxygen Desaturation Index (Efficacy)
Time Frame: Baseline through Month 7
Baseline through Month 7
Change in Functional Outcomes of Sleep Questionnaire (Efficacy
Time Frame: Baseline through Month 7
Baseline through Month 7
Change in Epworth Sleepiness Scale (Efficacy)
Time Frame: Baseline through Month 7
Baseline through Month 7
Change in EQ-5D (Efficacy)
Time Frame: Baseline through Month 7
Baseline through Month 7
Change in PROMIS SDI/SRI (Efficacy)
Time Frame: Baseline through Month 7
Baseline through Month 7
Change in CGI-S/CGI-I (Efficacy)
Time Frame: Baseline through Month 7
Baseline through Month 7
Descriptive analysis of all reported Adverse Events (Safety)
Time Frame: Consent through Month 7
Consent through Month 7
Change in SF-36 (Efficacy)
Time Frame: Baseline through Month 7
Baseline through Month 7

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

LivaNova

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 27, 2021

Primary Completion (ANTICIPATED)

October 1, 2023

Study Completion (ANTICIPATED)

July 1, 2024

Study Registration Dates

First Submitted

June 18, 2021

First Submitted That Met QC Criteria

June 25, 2021

First Posted (ACTUAL)

July 6, 2021

Study Record Updates

Last Update Posted (ACTUAL)

February 8, 2023

Last Update Submitted That Met QC Criteria

February 6, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LNS005

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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