UnknownNot Applicable

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

United States127 participantsStarted 2015-05

Plain-language summary

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

Age range22 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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
✓. 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.
✓. Age 22 or above
✓. Willing and capable to have stimulation hardware permanently implanted, and to use the patient remote to activate the stimulation
✓. Willing and capable to return for all follow-up visits and conduct sleep studies at home, including the evaluation procedures and filling out questionnaires
✓. Willing and capable of providing informed consent

✕. Central + mixed apneas \> 25% of the total apnea-hypopnea index (AHI)
✕. Any anatomical finding that would compromise the performance of upper airway stimulation, such as the presence of complete concentric collapse of the soft palate
✕. Any condition or procedure that has compromised neurological control of the upper airway
✕. Patients who are unable or do not have the necessary assistance to operate the patient remote
✕. Patients who are pregnant or plan to become pregnant
✕. Patients who will require magnetic resonance imaging (MRI)
✕. Patients with an implantable device that may be susceptible to unintended interaction with the Inspire system.
✕. Any chronic medical illness or condition that contraindicates a surgical procedure under general anesthesia, as judged by the clinical study Investigator

Long-term Device-Related SAEs

Timeframe: 5 Years Post-Implant

Therapy Specific AEs

Timeframe: 12 Months Post-Implant

Long-term Therapy-Related AEs

Timeframe: 5 Years Post-Implant

NCT IDNCT02413970

SponsorInspire Medical Systems, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-03

Who can participate

Age range22 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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
✓. 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.
✓. Age 22 or above
✓. Willing and capable to have stimulation hardware permanently implanted, and to use the patient remote to activate the stimulation
✓. Willing and capable to return for all follow-up visits and conduct sleep studies at home, including the evaluation procedures and filling out questionnaires
✓. Willing and capable of providing informed consent

✕. Central + mixed apneas \> 25% of the total apnea-hypopnea index (AHI)
✕. Any anatomical finding that would compromise the performance of upper airway stimulation, such as the presence of complete concentric collapse of the soft palate
✕. Any condition or procedure that has compromised neurological control of the upper airway
✕. Patients who are unable or do not have the necessary assistance to operate the patient remote
✕. Patients who are pregnant or plan to become pregnant
✕. Patients who will require magnetic resonance imaging (MRI)
✕. Patients with an implantable device that may be susceptible to unintended interaction with the Inspire system.
✕. Any chronic medical illness or condition that contraindicates a surgical procedure under general anesthesia, as judged by the clinical study Investigator