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Treating Obstructive Sleep Apnea Using Targeted Hypoglossal Neurostimulation (OSPREY)

Primary Purpose

Obstructive Sleep Apnea, OSA, Apnea

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Hypoglossal Nerve Stimulation
Sponsored by
LivaNova
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obstructive Sleep Apnea focused on measuring OSA, Snoring, Obstructive Sleep Apnea, CPAP, PAP

Eligibility Criteria

22 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Alabama At BirminghamRecruiting
  • Banner HealthRecruiting
  • University of ArizonaRecruiting
  • Sacramento EntRecruiting
  • Paul Schalch Lepe, Md/Silenso ClinicRecruiting
  • Sleep Medicine Specialists of South FloridaRecruiting
  • Morton Plant Mease Health CareRecruiting
  • Advanced Ent AssociatesRecruiting
  • Norton HealthcareRecruiting
  • Alivation Research LlcRecruiting
  • Hackensack University Medical CenterRecruiting
  • Weill Cornell Medical CollegeRecruiting
  • Raleigh Neurology Associates, PaRecruiting
  • Penn State HealthRecruiting
  • Philadelphia Ear, Nose and Throat AssociatesRecruiting
  • Medical University of South CarolinaRecruiting
  • Bogan Sleep Consultants, LlcRecruiting
  • Houston MethodistRecruiting
  • Epic Medical ResearchRecruiting
  • University of UtahRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Other

Arm Label

Active

Control

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.
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).

Secondary Outcome Measures

Decrease in Oxygen Desaturation Index (Efficacy)
Change in Functional Outcomes of Sleep Questionnaire (Efficacy
Change in Epworth Sleepiness Scale (Efficacy)
Change in EQ-5D (Efficacy)
Change in PROMIS SDI/SRI (Efficacy)
Change in SF-36 (Efficacy)
Change in CGI-S/CGI-I (Efficacy)
Descriptive analysis of all reported Adverse Events (Safety)

Full Information

First Posted
June 18, 2021
Last Updated
February 6, 2023
Sponsor
LivaNova
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1. Study Identification

Unique Protocol Identification Number
NCT04950894
Brief Title
Treating Obstructive Sleep Apnea Using Targeted Hypoglossal Neurostimulation
Acronym
OSPREY
Official Title
Treating Obstructive Sleep Apnea Using Targeted Hypoglossal Neurostimulation
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 27, 2021 (Actual)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
July 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
LivaNova

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea, OSA, Apnea, Apnea, Obstructive, Apnea, Obstructive Sleep, Apnea+Hypopnea, Hypopnea, Sleep
Keywords
OSA, Snoring, Obstructive Sleep Apnea, CPAP, PAP

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
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.
Masking
InvestigatorOutcomes Assessor
Masking Description
PSG results are masked from the Investigator and Outcomes Assessor.
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Active
Arm Type
Active Comparator
Arm Description
HGN therapy activation at Month 1 - compared at Month 7 to Control group, continued stimulation through Month 13
Arm Title
Control
Arm Type
Other
Arm Description
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
Intervention Type
Device
Intervention Name(s)
Hypoglossal Nerve Stimulation
Intervention Description
Hypoglossal Nerve Stimulation started at Month 1 compared to no Stimulation (Control group will start stimulation at M7+1Day)
Primary Outcome Measure Information:
Title
Rate of response to therapy when compared to no therapy for 6 months
Description
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.
Time Frame
Month 1 through Month 7
Title
Rate of all serious adverse device/procedure related events from time of implant through month 7
Description
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).
Time Frame
Month 1 through Month 7
Secondary Outcome Measure Information:
Title
Decrease in Oxygen Desaturation Index (Efficacy)
Time Frame
Baseline through Month 7
Title
Change in Functional Outcomes of Sleep Questionnaire (Efficacy
Time Frame
Baseline through Month 7
Title
Change in Epworth Sleepiness Scale (Efficacy)
Time Frame
Baseline through Month 7
Title
Change in EQ-5D (Efficacy)
Time Frame
Baseline through Month 7
Title
Change in PROMIS SDI/SRI (Efficacy)
Time Frame
Baseline through Month 7
Title
Change in SF-36 (Efficacy)
Time Frame
Baseline through Month 7
Title
Change in CGI-S/CGI-I (Efficacy)
Time Frame
Baseline through Month 7
Title
Descriptive analysis of all reported Adverse Events (Safety)
Time Frame
Consent through Month 7

10. Eligibility

Sex
All
Minimum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nadine Juran, BSN, RN
Phone
216-408-1316
Email
OSPREY.Study@livanova.com
First Name & Middle Initial & Last Name or Official Title & Degree
Amy Keith
Phone
832-205-5154
Email
OSPREY.Study@livanova.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Atul Malhotra, MD
Organizational Affiliation
UCSD Pulmonary and Critical Care Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama At Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
CHARLES BOWER, BS, CCRC
Email
charlesbower@uabmc.edu
First Name & Middle Initial & Last Name & Degree
KIRK WITHROW, MD
Facility Name
Banner Health
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85006
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
JUDY GALAZ, CRC
Email
cgalaz@arizona.edu
First Name & Middle Initial & Last Name & Degree
JOYCE LEE-IANNOTTI, MD
Facility Name
University of Arizona
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
MAGGIE DRURY, MS, CRC
Email
medrury@arizona.edu
First Name & Middle Initial & Last Name & Degree
SAIF MASHAQI, MD
Facility Name
Sacramento Ent
City
Roseville
State/Province
California
ZIP/Postal Code
95661
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
ROSE KHALATYAN, MPH, CCRP
Email
rkhalatyan@davinciresearch.net
First Name & Middle Initial & Last Name & Degree
MARCY ADAME, CPT, CCMA
Email
madame@davinciresearch.net
First Name & Middle Initial & Last Name & Degree
RANDALL OW, MD
Facility Name
Paul Schalch Lepe, Md/Silenso Clinic
City
San Diego
State/Province
California
ZIP/Postal Code
92130
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
ALEN PUTROS
Email
ALENPUTROS@GMAIL.COM
First Name & Middle Initial & Last Name & Degree
PAUL SCHALCH LEPE, MD
Facility Name
Sleep Medicine Specialists of South Florida
City
Miami
State/Province
Florida
ZIP/Postal Code
33126
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
OLIVIA FALCON, CRC
Email
oliviafalcon@southfloridasleeps.com
First Name & Middle Initial & Last Name & Degree
EDWARD MEZERHANE, MD
Facility Name
Morton Plant Mease Health Care
City
Safety Harbor
State/Province
Florida
ZIP/Postal Code
34695
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
MARIETTA BIBBS, BA, RPSGT, CCSH, FAAST
Email
Marietta.Bibbs@baycare.org
First Name & Middle Initial & Last Name & Degree
MITCHELL MILLER, MD
Facility Name
Advanced Ent Associates
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
ANNA GIGLIA
Email
agiglia@advancedentpc.com
First Name & Middle Initial & Last Name & Degree
SAMUEL MICKELSON, MD
Facility Name
Norton Healthcare
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40218
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
NANCY MCDONALD, RN, BSN,CCRC
Email
nancy.mcdonald@nortonhealthcare.org
First Name & Middle Initial & Last Name & Degree
KEVIN TRICE, MD
Facility Name
Alivation Research Llc
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68526
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
ELIZABETH LUDWIG, MD
Email
Lludwig@alivation.com
First Name & Middle Initial & Last Name & Degree
WALTER DUFFY, MD
Facility Name
Hackensack University Medical Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
ROSE WILLIAMS, MBA, MSCRA, CCRP
Email
rose.williams@hmhn.org
First Name & Middle Initial & Last Name & Degree
DEBORAH GOSS, MD
Facility Name
Weill Cornell Medical College
City
New York
State/Province
New York
ZIP/Postal Code
10024
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
TERESA VALDERRAMA, CRC
Email
tev2002@med.cornell.edu
First Name & Middle Initial & Last Name & Degree
ASHUTOSH KACKER, MD
Facility Name
Raleigh Neurology Associates, Pa
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27607
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
TAYLOR CESTARI, CRC
Email
tcestari@mcrmed.com
First Name & Middle Initial & Last Name & Degree
TOM PERKINS, MD
Facility Name
Penn State Health
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
HEATHER BRANTNER, CRC
Email
hbrantner@pennstatehealth.psu.edu
First Name & Middle Initial & Last Name & Degree
NEERAV GOYAL, MD
Facility Name
Philadelphia Ear, Nose and Throat Associates
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
MARY HAWKSHAW, CRC
Email
mhawkshaw@phillyent.com
First Name & Middle Initial & Last Name & Degree
ROBERT SATALOFF, MD
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shaun Nguyen, MD
Email
nguyensh@musc.edu
First Name & Middle Initial & Last Name & Degree
TED MEYER, MD
First Name & Middle Initial & Last Name & Degree
SHAUN NGUYEN, MD
Facility Name
Bogan Sleep Consultants, Llc
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29201
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
HEATHER BYRD
Email
Heather.Byrd@bogansleep.com
First Name & Middle Initial & Last Name & Degree
RICHARD BOGAN, MD
Facility Name
Houston Methodist
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
BEVIN LOPEZ, MS, CEP, CCRP
Email
balopez@houstonmethodist.org
First Name & Middle Initial & Last Name & Degree
MASAYOSHI TAKASHIMA, MD
Facility Name
Epic Medical Research
City
Red Oak
State/Province
Texas
ZIP/Postal Code
75154
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
JOSIE QUEMADO, CRC
Email
jquemado@epicmedresearch.com
First Name & Middle Initial & Last Name & Degree
HARESH BOGHARA, MD
Facility Name
University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84108
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
ANDRIEA SMITH, CRC
Email
Andriea.Smith@hsc.utah.edu
First Name & Middle Initial & Last Name & Degree
KRISHNA SUNDAR, MD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35613672
Citation
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.
Results Reference
derived

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Treating Obstructive Sleep Apnea Using Targeted Hypoglossal Neurostimulation

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