Obstructive Sleep Apnea (OSA) Sleep Apnea
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Scheduled for DISEAge = 18 years;AHI = 15 events per hour;Failure of, or intolerance to, PAP therapy;Central and mixed sleep apnea events accounting for less than 25% of the total AHIBody mass index (BMI) = 35 kg/m²
Exclusion criteria
Exclusion criteria: History of upper airway surgery that could alter DISE interpretation and surgical treatment outcomes, except for prior tonsillectomy and/or adenoidectomy;Current pregnancy;Inability or unwillingness to provide written informed consent;Contraindications to general anesthesia or to surgical procedures.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dichotomous: Therapy success at 1 year (yes/no) following HGNS treatment, defined according to the Sher criteria (10):=50% reduction in AHI compared to baseline andPostoperative AHI <20 events/hour.Continuous: Postoperative AHI (events/hour) | — |
Secondary
| Measure | Time frame |
|---|---|
| Postoperative AHI Overall AHI (events/hour)AHI in supine position (events/hour)AHI in non-supine position (events/hour)PhOP measure (cm H20) | — |
Countries
Netherlands
Contacts
OLVG