None listed
Conditions
Brief summary
Hypoglossal nerve stimulation (HNS) has been shown to be a safe and effective treatment option for patients with moderate to severe obstructive sleep apnea (OSA). However, since the introduction of HNS in clinical practice, approximately one third of the implanted patients do not demonstrate clinically meaningful improvement. This study will evaluate whether chronic ansa cerivalis stimulation (ACS) in combination with HNS during natural sleep will yield a clinical meaningful improvement for OSA patients.
Interventions
The Restora Clinical System (RCS) consists of implantable pulse generator (IPG) and its accessories, 2 lead wires implanted on the two targeted nerves, and an adapter connecting lead wires and IPG. The RCS system will be implanted during surgery by a head and neck surgeon. RCS is intended to unilaterally stimulate the hypoglossal nerve which innervates the muscles in the tongue and the ansa cervicalis nerve which innervates the infrahyoid muscles. The device is intended to be used by the partici
The Restora Clinical System (RCS) consists of implantable pulse generator (IPG) and its accessories, 2 lead wires implanted on the two targeted nerves, and an adapter connecting lead wires and IPG. The RCS system will be implanted during surgery by a head and neck surgeon. RCS is intended to unilaterally stimulate the hypoglossal nerve which innervates the muscles in the tongue and the ansa cervicalis nerve which innervates the infrahyoid muscles. The device is intended to be used by the participant every night during sleep period. After device implantation (approximately 60 minutes), participants will need to complete the following study procedures: - Follow-up visits at the study clinic to complete quality of life questionnaires (approximately 30 minutes) at 1, 3, 6, 9, 12, 18 and 24 months post-device implantation - Overnight polysomnography visits (minimum 8 hours) at the study sleep clinic at 1, 2, 3, 6, 12 and 24 months post-device implantation (to be completed after quality of life questionnaires, as applicable to the visit) - Home sleep apnea tests (minimum 8 hours for 3 nights) at the participant’s home at 1, 2, 3, and 6 months post-device implantation (to be completed after overnight polysomnography) The study period is 2 years, participants are allowed to continue to use RCS in accordance with standard of care. Participants will be closely monitored by study team using aforementioned study procedures.
Sponsors
Restora Medical
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
22 Years to No maximum
Healthy volunteers
No
Inclusion criteria
- AHI greater than or equal to 15 events per hour -Body mass index (BMI) less than or equal too 35 kg/m2 -Participants followed standard of care in considering all other alternative/adjunct therapies and failed or not tolerated CPAP treatment -Willing and capable to consent, of having stimulation hardware permanently implanted, and using the device, and of complying with protocol requirements
Exclusion criteria
-BMI < 20 kg/m2 -AHI > 65 events per hour -Central or mix apnea and hypopnea > 25% -In the opinion of the investigator, concomitant sleep disorders that are not adequately treated and could confound functional assessments of sleepiness, or taking medications that may alter consciousness, the pattern of respiration, or sleep architecture. -Significantly enlarged goiter at intended implant side or planned thyroidectomy in the next 6 months
Outcome results
None listed