Treating Obstructive Sleep Apnea Using Targeted Hypoglossal Neurostimulation

Obstructive Sleep Apnea Clinical Trial

— OSPREY  

Official title:

Treating Obstructive Sleep Apnea Using Targeted Hypoglossal Neurostimulation

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04950894
• Other study ID #: LNS005
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 27, 2021
• Est. completion date: April 2025

Study information

• Verified date: June 2024
• Source: LivaNova
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 150
• Est. completion date: April 2025
• Est. primary completion date: October 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Apnea
• Apnea, Obstructive
• Apnea, Obstructive Sleep
• Obstructive Sleep Apnea
• OSA
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

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

Locations

Country	Name	City	State
United States	Advanced Ent Associates	Atlanta	Georgia
United States	University of Alabama At Birmingham	Birmingham	Alabama
United States	Medical University of South Carolina	Charleston	South Carolina
United States	Bogan Sleep Consultants, Llc	Columbia	South Carolina
United States	Hackensack University Medical Center	Hackensack	New Jersey
United States	Penn State Health	Hershey	Pennsylvania
United States	Houston Methodist	Houston	Texas
United States	Alivation Research Llc	Lincoln	Nebraska
United States	Norton Healthcare	Louisville	Kentucky
United States	Sleep Medicine Specialists of South Florida	Miami	Florida
United States	Weill Cornell Medical College	New York	New York
United States	Philadelphia Ear, Nose and Throat Associates	Philadelphia	Pennsylvania
United States	Banner Health	Phoenix	Arizona
United States	Raleigh Neurology Associates, Pa	Raleigh	North Carolina
United States	Epic Medical Research	Red Oak	Texas
United States	Sacramento Ent	Roseville	California
United States	Morton Plant Mease Health Care	Safety Harbor	Florida
United States	University of Utah	Salt Lake City	Utah
United States	Paul Schalch Lepe, Md/Silenso Clinic	San Diego	California
United States	University of Arizona	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
LivaNova

Country where clinical trial is conducted

United States, 

Outcome

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