Last updated on March 2019

Inspire Post-Approval Study / Protocol Number 2014-001

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Obstructive sleep apnea
  • Age: Between 22 - 100 Years
  • Gender: Male or Female

Inclusion Criteria:

  1. Likely suffer moderate-to-severe OSA based on history and physical or have an established diagnosis of OSA (20AHI65) based on a prior in-lab Polysomnography
  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:

  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. Body Mass Index (BMI) of > 32
  2. Any chronic medical illness or condition that contraindicates a surgical procedure under general anesthesia, as judged by the clinical study Investigator
  3. Has a terminal illness with life expectancy < 12 months
  4. Active psychiatric disease (psychotic illness, major depression, or acute anxiety attacks) which prevents subject compliance with the requirements of the investigational study testing
  5. Any other reason the investigator deems subject is unfit for participation in the study

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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