Brief Summary
The purpose of this study is to evaluate the benefits and risks of hypoglossal nerve stimulation with the Apnex Medical Hypoglossal Nerve Stimulation (HGNS) System as a potential therapeutic option for individuals with moderate to severe Obstructive Sleep Apnea (OSA) that have failed or do not tolerate positive airway pressure (PAP) therapy.
Brief Title
Apnex Clinical Study of the Hypoglossal Nerve Stimulation (HGNS®) System to Treat Obstructive Sleep Apnea
Categories
Completion Date
Completion Date Type
Actual
Conditions
Obstructive Sleep Apnea
Eligibility Criteria
Inclusion Criteria:
* Age 21 to 80 years
* Body mass index (BMI) ≤ 35 kg/m²
* Previously diagnosed with Moderate to severe OSA
* Individual has failed or does not tolerate PAP therapy
* Age 21 to 80 years
* Body mass index (BMI) ≤ 35 kg/m²
* Previously diagnosed with Moderate to severe OSA
* Individual has failed or does not tolerate PAP therapy
Inclusion Criteria
Inclusion Criteria:
* Age 21 to 80 years
* Body mass index (BMI) ≤ 35 kg/m²
* Previously diagnosed with Moderate to severe OSA
* Individual has failed or does not tolerate PAP therapy
* Age 21 to 80 years
* Body mass index (BMI) ≤ 35 kg/m²
* Previously diagnosed with Moderate to severe OSA
* Individual has failed or does not tolerate PAP therapy
Gender
All
Gender Based
false
Keywords
Apnea
OSA
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Hypoglossal Nerve Stimulation
Sleep Disorders
Tongue
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Estimated
Last Update Submit Date
Maximum Age
80 Years
Minimum Age
21 Years
NCT Id
NCT01446601
Org Class
Industry
Org Full Name
Apnex Medical, Inc.
Org Study Id
CLP-005
Overall Status
Terminated
Phases
Phase 3
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
Pivotal Study of the Apnex Medical™ Hypoglossal Nerve Stimulation (HGNS) System to Treat Obstructive Sleep Apnea
Primary Outcomes
Outcome Description
The proportion of subjects that experience clinically meaningful improvement in AH1 (reduction \>50% and AHI \<20) and ODI 4% (reduction \>= 25% or ODI 4% \<5)from Baseline to 6 Months will be significantly greater in the Treatment Group compared to the Control Group
Outcome Measure
Reduction in OSA Severity
Outcome Time Frame
from Baseline to 6 Months
Outcome Description
The proportion of subjects in the Treatment Group that experience clinically relevant improvement in AHI (reduction \>50% and AHI \<20) and ODI 4% (reduction \>=25% or ODI 4% \<5 at 12 months compared to Baseline.
Outcome Measure
Long-term Reduction in OSA Severity
Outcome Time Frame
12 months
Outcome Description
Description of all adverse events
Outcome Measure
Safety Analysis
Outcome Time Frame
12 months
Secondary Ids
Secondary Id
IDE #G090014
Start Date
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
80
Minimum Age Number (converted to Years and rounded down)
21
Investigators
Investigator Type
Principal Investigator
Investigator Name
Steven Park
Investigator Email
stpark@montefiore.org
Investigator Phone
929-263-3134
Categories Mesh Debug
Mental Health & Behavioral Research --- SLEEP WAKE DISORDERS
Asthma and Other Respiratory Diseases --- RESPIRATORY TRACT DISEASES
Lung & Chest Cancers --- RESPIRATORY TRACT DISEASES
COVID-19 --- RESPIRATORY TRACT DISEASES
Lung --- RESPIRATORY TRACT DISEASES
Mental Health & Behavioral Research --- SLEEP DISORDERS, INTRINSIC
Mental Health & Behavioral Research --- DYSSOMNIAS
Brain, Spinal Cord & Nervous System --- NERVOUS SYSTEM DISEASES
Brain, Spine & Nerve Cancers --- NERVOUS SYSTEM DISEASES
Brain, Spinal Cord & Nervous System --- NEUROLOGIC MANIFESTATIONS
Headaches & Migraine --- NEUROLOGIC MANIFESTATIONS
Substance Use and Addiction --- NEUROLOGIC MANIFESTATIONS
Child Development & Autism --- MENTAL DISORDERS
Mental Health & Behavioral Research --- MENTAL DISORDERS
Psychiatry & Behavioral Sciences --- MENTAL DISORDERS
Substance Use and Addiction --- MENTAL DISORDERS
MeSH Terms
SLEEP APNEA, OBSTRUCTIVE
APNEA
SLEEP APNEA SYNDROMES
SLEEP WAKE DISORDERS
RESPIRATION DISORDERS
RESPIRATORY TRACT DISEASES
SLEEP DISORDERS, INTRINSIC
DYSSOMNIAS
NERVOUS SYSTEM DISEASES
SIGNS AND SYMPTOMS, RESPIRATORY
SIGNS AND SYMPTOMS
PATHOLOGICAL CONDITIONS, SIGNS AND SYMPTOMS
NEUROLOGIC MANIFESTATIONS
MENTAL DISORDERS
DRUG DELIVERY SYSTEMS
DRUG THERAPY
THERAPEUTICS