RecruitingACTRN12626000469314

An Early Feasibility Study of Neuromodulation therapy for Obstructive Sleep Apnea (OSA)

An Early Feasibility Study of Neuromodulation therapy for Obstructive Sleep Apnea (OSA) in Participants 22 years and older

Sponsor

The Alfred E. Mann Foundation for Scientific Research (HuMannity Medtec)

Enrollment

10 participants

Start Date

Feb 2, 2026

Study Type

Interventional

Conditions

Obstructive Sleep Apnea (OSA)

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.

Eligibility

Sex: Both males and femalesMin Age: 22 Yearss

Inclusion Criteria6

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 Criteria6

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%

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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. 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