Active — Not RecruitingNot Applicable

Treating Obstructive Sleep Apnea Using Targeted Hypoglossal Neurostimulation

United States150 participantsStarted 2021-07-27

Plain-language summary

Multi-center, open-label, prospective, randomized clinical trial of the aura6000(R) System for the reduction of apnea and hypopneas in adult patients with moderate to severe obstructive sleep apnea who have failed or are unwilling to use positive airway pressure treatment.

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.

Abbreviated: Additional criteria may apply: Inclusion Criteria: * Diagnosis of moderate to severe OSA * Declines to use or does not tolerate PAP therapy Exclusion Criteria: * Respiratory, cardiac, renal disease or other co-morbid conditions * BMI \> 35 kg/m2 * Specific PSG criteria outlined in the protocol

What they're measuring

Rate of response to therapy when compared to no therapy for 6 months

Timeframe: Month 1 through Month 7

Rate of all serious adverse device/procedure related events from time of implant through month 7

Timeframe: Month 1 through Month 7

Trial details

NCT IDNCT04950894

SponsorLivaNova

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-10-30

View on ClinicalTrials.gov More Obstructive Sleep Apnea trials