OSPREY: Treating Obstructive Sleep Apnea Using Targeted Hypoglossal Neurostimulation

Sponsor

LivaNova (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04950894

Collaborator

(none)

150

Enrollment

Locations

Arms

23.1

Anticipated Duration (Months)

7.5

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Obstructive Sleep Apnea OSA Apnea Apnea, Obstructive Apnea, Obstructive Sleep Apnea+Hypopnea Hypopnea, Sleep	Device: Hypoglossal Nerve Stimulation	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

150 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Intervention 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.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:

Double (Investigator, Outcomes Assessor)

Masking Description:

PSG results are masked from the Investigator and Outcomes Assessor.

Primary Purpose:

Treatment

Official Title:

Treating Obstructive Sleep Apnea Using Targeted Hypoglossal Neurostimulation

Actual Study Start Date :

Jul 27, 2021

Anticipated Primary Completion Date :

Jan 1, 2023

Anticipated Study Completion Date :

Jul 1, 2023

Arms and Interventions

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)

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)

Outcome Measures

Primary Outcome Measures

Rate of response to therapy when compared to no therapy for 6 months [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.
Rate of all serious adverse device/procedure related events from time of implant through month 7 [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).

Secondary Outcome Measures

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]
Change in SF-36/SF-6 (Efficacy) [Baseline through Month 7]
Change in CGI-S/CGI-I (Efficacy) [Baseline through Month 7]
Descriptive analysis of all reported Adverse Events (Safety) [Consent through Month 7]

Eligibility Criteria

Criteria

Ages Eligible for Study:

22 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Alabama At Birmingham	Birmingham	Alabama	United States	35294
2	Banner Health	Phoenix	Arizona	United States	85006
3	University of Arizona	Tucson	Arizona	United States	85724
4	Sacramento Ent	Roseville	California	United States	95661
5	Paul Schalch Lepe, Md/Silenso Clinic	San Diego	California	United States	92130
6	Sleep Medicine Specialists of South Florida	Miami	Florida	United States	33126
7	Morton Plant Mease Health Care	Safety Harbor	Florida	United States	34695
8	Advanced Ent Associates	Atlanta	Georgia	United States	30342
9	Norton Healthcare	Louisville	Kentucky	United States	40218
10	Alivation Research Llc	Lincoln	Nebraska	United States	68526
11	Hackensack University Medical Center	Hackensack	New Jersey	United States	07601
12	Weill Cornell Medical College	New York	New York	United States	10024
13	Raleigh Neurology Associates, Pa	Raleigh	North Carolina	United States	27607
14	Penn State Health	Hershey	Pennsylvania	United States	17033
15	Philadelphia Ear, Nose and Throat Associates	Philadelphia	Pennsylvania	United States	19107
16	Medical University of South Carolina	Charleston	South Carolina	United States	29425
17	Bogan Sleep Consultants, Llc	Columbia	South Carolina	United States	29201
18	Houston Methodist	Houston	Texas	United States	77030
19	Epic Medical Research	Red Oak	Texas	United States	75154
20	University of Utah	Salt Lake City	Utah	United States	84108