What this phase means
This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
If you join, the listed intervention(s) are Continuous Positive Airway Pressure (CPAP). The registry lists allocation as randomized. The goal of this study is to obtain pilot data investigating the effects of sleep apnea on mitochondrial function and cellular metabolism in Polyendocrine Metabolic Ovarian Syndrome (PMOS) patients.
They plan to enroll about 10 people at Chicago. Taking part typically means using or being fitted with a device plus check-ins.
Official title (unrewritten)
Metabolic Changes in PMOS Patients With Obstructive Sleep Apnea (OSA) Pilot Study
Interventions: Continuous Positive Airway Pressure (CPAP)
Primary outcome (registry wording): Complex I and II/Electron Transport System Capacity