Clinical trial NCT04950894: Treating Obstructive Sleep Apnea Using Targeted Hypoglossal Neurostimulation
Official title: Treating Obstructive Sleep Apnea Using Targeted Hypoglossal Neurostimulation
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Obstructive Sleep Apnea
OSA
Apnea
Apnea, Obstructive
Apnea, Obstructive Sleep
Apnea+Hypopnea
Hypopnea, Sleep
Keywords: OSA
Snoring
Obstructive Sleep Apnea
CPAP
PAP
Lead sponsor: LivaNova
Sponsor class: INDUSTRY
First posted: 2021-07-06
Enrollment: 150
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Rate of response to therapy when compared to no therapy for 6 months
timeFrame: Month 1 through Month 7
measure: Rate of all serious adverse device/procedure related events from time of implant through month 7
timeFrame: Month 1 through Month 7
Secondary outcomes:
measure: Decrease in Oxygen Desaturation Index (Efficacy)
timeFrame: Baseline through Month 7
measure: Change in Functional Outcomes of Sleep Questionnaire (Efficacy
timeFrame: Baseline through Month 7
measure: Change in Epworth Sleepiness Scale (Efficacy)
timeFrame: Baseline through Month 7
measure: Change in EQ-5D (Efficacy)
timeFrame: Baseline through Month 7
measure: Change in PROMIS SDI/SRI (Efficacy)
timeFrame: Baseline through Month 7
measure: Change in SF-36 (Efficacy)
timeFrame: Baseline through Month 7
measure: Change in CGI-S/CGI-I (Efficacy)
timeFrame: Baseline through Month 7
measure: Descriptive analysis of all reported Adverse Events (Safety)
timeFrame: Consent through Month 7
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama At Birmingham
state: Alabama
city: Phoenix
country: United States
facility: Banner Health
state: Arizona
city: Tucson
country: United States
facility: University of Arizona
state: Arizona
city: Roseville
country: United States
facility: Sacramento Ent
state: California
city: San Diego
country: United States
facility: Paul Schalch Lepe, Md/Silenso Clinic
state: California
city: Miami
country: United States
facility: Sleep Medicine Specialists of South Florida
state: Florida
city: Safety Harbor
country: United States
facility: Morton Plant Mease Health Care
state: Florida
city: Atlanta
country: United States
facility: Advanced Ent Associates
state: Georgia
city: Louisville
country: United States
facility: Norton Healthcare
state: Kentucky
city: Lincoln
country: United States
facility: Alivation Research Llc
state: Nebraska
city: Hackensack
country: United States
facility: Hackensack University Medical Center
state: New Jersey
city: New York
country: United States
facility: Weill Cornell Medical College
state: New York
city: Raleigh
country: United States
facility: Raleigh Neurology Associates, Pa
state: North Carolina
city: Hershey
country: United States
facility: Penn State Health
state: Pennsylvania
city: Philadelphia
country: United States
facility: Philadelphia Ear, Nose and Throat Associates
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Columbia
country: United States
facility: Bogan Sleep Consultants, Llc
state: South Carolina
city: Houston
country: United States
facility: Houston Methodist
state: Texas
city: Red Oak
country: United States
facility: Epic Medical Research
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
Study officials:
affiliation: UCSD Pulmonary and Critical Care Medicine
name: Atul Malhotra, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.