For Healthcare Professionals

Inspire® Post-Approval Study / Protocol Number 2014-001

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About the study

The purpose of this study is to obtain additional long-term safety and efficacy data on the use of Inspire therapy.
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Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION 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

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

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Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply


Contact the study center to learn if this study is a good match for you.

Study’s details


Contition

Obstructive Sleep Apnea

Age (in years)

22+

Phase

Not Applicable

Participants needed

127

Est. Completion Date

Jun 30, 2025

Treatment type

Interventional


Sponsor

Inspire Medical Systems, Inc.

ClinicalTrials.gov identifier

NCT02413970

Study number

2014-001

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