- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03760328
Effect of Upper Airway Stimulation in Patients With Obstructive Sleep Apnea (EFFECT)
Effect of Upper Airway Stimulation: A Randomized Controlled Crossover Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Obstructive Sleep Apnea (OSA) is characterized by recurrent episodes of airflow obstruction in the upper airway that results in oxygen desaturations and arousal from sleep. The most common symptom of OSA is excessive daytime sleepiness. Recent studies have also shown clear association of OSA with the development of obesity, hypertension diabetes mellitus, and congestive heart failure. Approximately 13% men and 6% women have moderate to severe OSA (apnea hypopnea index, AHI ≥ 15) in the US.
The efficacy of therapies for OSA, and in particular, continuous positive airway pressure (CPAP) has been limited due to patient intolerance, poor patient selection, or limited response to the therapy.
The Inspire Upper Airway Stimulation (UAS) system is intended to prevent upper airway obstruction by stimulating the hypoglossal nerve synchronous with respiration [7].
The Inspire system is comprised of the following components:
- Inspire Upper Airway Stimulator (Implantable Pulse Generator (IPG))
- Inspire Stimulation Lead
- Inspire Sensing Lead
External programmers used with the system are:
- Inspire Programmer (physician programmer)
- Inspire Patient Programmer (patient remote)
The Inspire system received CE Mark in 2010 (CE Certificate No. 562872) providing the regulatory authority to provide the device in a commercial setting. Furthermore, this study will be conducted within the CE marked intended use of the Inspire system and will not involve any additional stressful or invasive tests.
The objective of this randomized controlled crossover study is to assess treatment effect of Inspire UAS in patients at different time points with two different therapy settings. This study will provide additional clinical evidence of Inspire UAS for treatment of moderate to severe OSA using a randomized controlled crossover trial design.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Bayern
-
Munich, Bayern, Germany, 81675
- Department of Ear Nose Throat
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Otherwise healthy subjects that are at least 18 years old and:
- Have been implanted and using the Inspire Therapy for at least six months
- Willing and capable to undergo three in-lab PSGs in a one-month timeframe
- Willing and capable of having reduced Inspire stimulation for one week
- Willing and capable of providing informed consent
Exclusion Criteria:
Subjects who meet any of the following criteria will be excluded from this clinical investigation:
- Unwilling to complete three in-lab PSGs within a 1-month timeframe
- Any other reason the investigator deems subject is unfit for participation in the study
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: therapeutic stimulation
Therapeutic Stimulation: optimal therapy setting for home use
|
hypoglossal nerve stimulation by using a breathing cycle depended stimulation system of the upper airway
Other Names:
|
Sham Comparator: sham stimulation
Sham Stimulation (Control Group): stimulation voltage programmed at 0.1 volts
|
hypoglossal nerve stimulation by using a breathing cycle depended stimulation system of the upper airway
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in AHI from Baseline to Visit 1 and Visit 2
Time Frame: Baseline through Visit 1 (1 week) and Visit 2 (2 weeks)
|
Apnea Hypopnea Index (AHI) is a measure of OSA severity.
The AHI in this study will be determined by the AHI score at Visit 1 and Visit 2 compared with the baseline score.
|
Baseline through Visit 1 (1 week) and Visit 2 (2 weeks)
|
Change in ESS from Baseline to Visit 1 and Visit 2
Time Frame: Baseline through Visit 1 (1 week) and Visit 2 (2 weeks)
|
The Epworth Sleepiness Scale (ESS) is a validated instruction that rates a subject's daytime sleepiness.
The ESS efficacy endpoint will be determined by the ESS score at Visit 1 and Visit 2 as compared to baseline.
|
Baseline through Visit 1 (1 week) and Visit 2 (2 weeks)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in FOSQ from Baseline to Visit 1 and Visit 2
Time Frame: Baseline through Visit 1 (1 week) and Visit 2 (2 weeks)
|
The Functional Outcomes of Sleep Questionnaire (FOSQ) is a validated instrument to assess the effect of a subject's daytime sleepiness on activities of ordinary living.
The FOSQ endpoint will be determined by the FOSQ score at Visit 1 and Visit 2 as compared to baseline.
|
Baseline through Visit 1 (1 week) and Visit 2 (2 weeks)
|
Change in Snoring Intensity from Baseline to Visit 1 and Visit 2
Time Frame: Baseline through Visit 1 (1 week) and Visit 2 (2 weeks)
|
Snoring Intensity will be measured by using a visual analoge scale from 0 (no snoring) to 10 (heavy snoring).
The snoring intensity endpoint will be determined by the visual analogue scale at Visit 1 and Visit 2 as compared to baseline.
|
Baseline through Visit 1 (1 week) and Visit 2 (2 weeks)
|
Therapy Adherence
Time Frame: Baseline through Visit 1 (1 week) and Visit 2 (2 weeks)
|
Therapy use, reported as hours of use per week, is record by Inspire device and can be collected upon interrogation of the device in the clinic.
This value can be used to quantify device use and adherence over the investigated time period.
|
Baseline through Visit 1 (1 week) and Visit 2 (2 weeks)
|
Change in ODI from Baseline to Visit 1 and Visit 2
Time Frame: Baseline through Visit 1 (1 week) and Visit 2 (2 weeks)
|
Oxygen Desaturation Index (ODI) is a measure of OSA severity.
The ODI will be determined by the ODI score at Visit 1 and Visit 2 as compared with to baseline
|
Baseline through Visit 1 (1 week) and Visit 2 (2 weeks)
|
Change in Clinical Global Impression (CGI-I) from Baseline to Visit 1 and Visit 2
Time Frame: Baseline through Visit 1 (1 week) and Visit 2 (2 weeks)
|
The CGI-I is a seven point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention.
|
Baseline through Visit 1 (1 week) and Visit 2 (2 weeks)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Clemens Heiser, M.D., Klinikum rechts der Isar, Technical University of Munich
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EFFECT
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Obstructive Sleep Apnea
-
Mauro ManconiCompletedObstructive Sleep Apnea Syndrome | Sleep Apnea, Obstructive | Obstructive Sleep Apnea | OSA | Apnea, Obstructive | OSAHSwitzerland
-
LivaNovaRecruitingApnea | Obstructive Sleep Apnea | OSA | Apnea, Obstructive | Apnea+Hypopnea | Apnea, Obstructive Sleep | Hypopnea, SleepUnited States
-
University of California, Los AngelesRecruiting
-
Brigham and Women's HospitalCompletedObstructive Sleep Apnea (OSA)United States
-
State Budgetary Healthcare Institution, National...RecruitingObstructive Sleep Apnea | Obstructive Sleep Apnea-hypopnea | Obstructive Sleep Apnea-hypopnea SyndromeRussian Federation
-
The Hospital for Sick ChildrenCompleted
-
Cryosa, Inc.Active, not recruitingObstructive Sleep Apnea of AdultPanama, Paraguay
-
State Key Laboratory of Respiratory DiseaseCompletedObstructive Sleep Apnea of AdultChina
-
Somnics, Inc.UnknownObstructive Sleep Apnea of AdultTaiwan
-
ResMedCompletedObstructive Sleep Apnea (OSA)United States, Australia
Clinical Trials on Upper Airway Stimulation
-
University Hospital, GrenobleInspire Medical Systems, Inc.RecruitingObstructive Sleep Apnea SyndromeFrance
-
Inspire Medical Systems, Inc.Recruiting
-
Technical University of MunichCompleted
-
Somnial IncCompletedObstructive Sleep Apnea | OSAUnited States
-
University of PittsburghInspire Medical Systems, Inc.Completed
-
Inspire Medical Systems, Inc.National Institutes of Health (NIH); National Institute on Deafness and Other...RecruitingObstructive Sleep Apnea | Down SyndromeUnited States
-
Inspire Medical Systems, Inc.CompletedObstructive Sleep ApneaUnited States, Germany, Belgium, France, Netherlands
-
Inspire Medical Systems, Inc.Terminated
-
Inspire Medical Systems, Inc.CompletedObstructive Sleep ApneaGermany
-
Samsung Medical CenterCompletedShoulder Arthroscopic SurgeryKorea, Republic of