None listed
Conditions
Brief summary
This study will evaluate the safety of the HYPNOS System, a novel implantable hypoglossal nerve stimulation device designed to keep the airway open during sleep. Participants with moderate to severe OSA who cannot tolerate CPAP will be implanted with the system and followed for 24 months to assess safety and sleep outcomes.
Interventions
: An implantable hypoglossal nerve stimulation system consisting of an Implantable Pulse Generator (IPG) and stimulation lead cuff to maintain airway patency during sleep will be implanted by an ENT or trained surgeon. The IPG will be implanted in the upper chest region while the stimulation lead will be implanted in the neck region. The cuff itself is wrapped around the hypoglossal nerve. Stimulation parameters will be programmed to reflect the current standard of care for sleep apnea (e.g. Pul
: An implantable hypoglossal nerve stimulation system consisting of an Implantable Pulse Generator (IPG) and stimulation lead cuff to maintain airway patency during sleep will be implanted by an ENT or trained surgeon. The IPG will be implanted in the upper chest region while the stimulation lead will be implanted in the neck region. The cuff itself is wrapped around the hypoglossal nerve. Stimulation parameters will be programmed to reflect the current standard of care for sleep apnea (e.g. Pulse Amplitude 0.0 - 4.5mA, Pulse Width 62µs, Pulse Frequency 33Hz). The implant will provide therapy every night for the duration of sleep for 24 months. Participants will complete questionnaires to assess changes in sleep quality and impact on quality of life
Sponsors
The Alfred E. Mann Foundation for Scientific Research (HuMannity Medtec)
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
- Age 22 years or older at the time of implant - English language proficiency - BMI greater than or equal to 35 kg/m2 - Moderate-to-severe OSA (AHI 15–65 events/h using greater than or equal to 4% oxygen desaturation criteria, sleep efficiency greater than or equal to 75%, central/mixed greater than 25%) - Refused, failed, or intolerant to CPAP or oral appliance therapy - Willing and able to provide informed consent and comply with visits
Exclusion criteria
Exclusion Criteria (Protocol): - Severe uncontrolled respiratory, cardiac, or renal disease - Other implanted devices (pacemaker, ICD, VNS) - Significant comorbidities (neuromuscular disease, hypoglossal nerve palsy, psychiatric disease) - Substance/alcohol abuse within 3 years - Primary insomnia (ISI greater than or equal to 20) - PSG criteria outside AHI 15–65 (using greater than or equal to 4% oxygen desaturation criteria) or T-90 greater than 20%
Outcome results
None listed