Clinical trial NCT02413970: Inspire® Post-Approval Study / Protocol Number 2014-001
Official title: Inspire® Upper Airway Stimulation System (UAS): Post-Approval Study Protocol Number 2014-001
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Obstructive Sleep Apnea
Keywords: OSA
Neurostimulation
Hypoglossal nerve
Tongue
Upper airway stimulation
Surgery
Lead sponsor: Inspire Medical Systems, Inc.
Sponsor class: INDUSTRY
First posted: 2015-04-10
Enrollment: 127
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Inspire UAS
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to obtain additional long-term safety and efficacy data on the use of Inspire therapy.

Detailed description: This is a multi-center, prospective, single-arm study conducted under a common protocol. Each subject will serve as their own control. Each subject will be followed for 5 years from date of implant.

Potential study subjects will be considered for study participation and consented once pre-implant screening and implant qualification process have been completed. This includes an in-lab PSG, surgical consultation, and a drug-induced sleep endoscopy procedure.

This study will collect pre-operative baseline data including, verification of ineffective CPAP treatment, PSG information, medical history and subject quality of life measures. Intra- and post- operative procedure data will be collected.

Post-implant, procedure- and device-related adverse events, QoL questionnaires, Functional Tongue Exam, therapy usage and device adjustment data will be collected. In-lab PSG sleep study data will be collected during the 2-month and 1 \& 3 year follow-up visits, home sleep tests will be conducted and data collected at the 6-month and 2, 4, \& 5 year follow-up visits.

The subject population will consist of otherwise healthy men and women that are at least 22 years old and have: 1) Provided written informed consent to participate, 2) Indicated a willingness to comply with the study requirements for the specified follow-up duration, and 3) Met all inclusion and exclusion criteria of this protocol.

Up to 127 subjects will be implanted at a minimum of 10 and a maximum of 20 qualified sites in the United States.

Eligibility criteria: Inclusion Criteria:

1. Likely suffer moderate-to-severe OSA based on history and physical or have an established diagnosis of OSA (AHI \>= 15) based on a prior sleep study
2. Documentation the subject not effectively treated with CPAP therapy. (Examples include non-compliance, discomfort, undesirable side effects, symptoms persist despite use). Subjects who have been prescribed, but refuse to try CPAP would be considered intolerant.
3. Age 22 or above
4. Willing and capable to have stimulation hardware permanently implanted, and to use the patient remote to activate the stimulation
5. Willing and capable to return for all follow-up visits and conduct sleep studies at home, including the evaluation procedures and filling out questionnaires
6. Willing and capable of providing informed consent

Exclusion Criteria:

Contraindications:

1. Central + mixed apneas \> 25% of the total apnea-hypopnea index (AHI)
2. Any anatomical finding that would compromise the performance of upper airway stimulation, such as the presence of complete concentric collapse of the soft palate
3. Any condition or procedure that has compromised neurological control of the upper airway
4. Patients who are unable or do not have the necessary assistance to operate the patient remote
5. Patients who are pregnant or plan to become pregnant
6. Patients who will require magnetic resonance imaging (MRI)
7. Patients with an implantable device that may be susceptible to unintended interaction with the Inspire system.

Additional exclusions for study purposes only:

1. Any chronic medical illness or condition that contraindicates a surgical procedure under general anesthesia, as judged by the clinical study Investigator
2. Has a terminal illness with life expectancy \< 12 months
3. Active psychiatric disease (psychotic illness, major depression, or acute anxiety attacks) which prevents subject compliance with the requirements of the investigational study testing
4. Any other reason the investigator deems subject is unfit for participation in the study

Primary outcomes:
measure: Long-term Device-Related SAEs
timeFrame: 5 Years Post-Implant
measure: Therapy Specific AEs
timeFrame: 12 Months Post-Implant
measure: Long-term Therapy-Related AEs
timeFrame: 5 Years Post-Implant
Secondary outcomes:
measure: Number of Acute AEs Reported with Newly Trained Physicians as Compared to Experienced Physicians
timeFrame: 30 days post-implant
Other outcomes:
measure: Change in ESS From Baseline to 12 Months
timeFrame: Baseline and 12 Months
measure: Change in FOSQ From Baseline to 12 Months
timeFrame: Baseline and 12 Months
measure: Change in ODI From Baseline to 3 Years
timeFrame: Baseline and 3 Years
measure: Change in AHI From Baseline to 3 Years
timeFrame: Baseline and 3 Years
Locations:
city: Birmingham
country: United States
facility: The University of Alabama at Birmingham Medical Center
state: Alabama
city: Los Angeles
country: United States
facility: University of Southern California
state: California
city: Miami
country: United States
facility: South Miami Hospital
state: Florida
city: Tampa
country: United States
facility: Tampa General Hospital
state: Florida
city: Kansas City
country: United States
facility: The University of Kansas Medical Center
state: Kansas
city: Louisville
country: United States
facility: Kentucky Research Group
state: Kentucky
city: New York
country: United States
facility: Weill Cornell Medicine
state: New York
city: Cincinnati
country: United States
facility: The Christ Hospital
state: Ohio
city: Cleveland
country: United States
facility: University Hospitals
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Philadelphia
country: United States
facility: University of Pennsylvania, Division of Sleep Medicine
state: Pennsylvania
city: Philadelphia
country: United States
facility: Thomas Jefferson University and Hospital
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: Inspire Medical Systems, Inc.
name: Gwen Gimmestad
role: STUDY_DIRECTOR
References: