PMOS in OSA Pilot Study
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-40
SponsorUniversity of Chicago
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Women 18-40 years old
PMOS diagnosis
Sleep Apnea (AHI>5) diagnosed by home sleep test (WatchPAT One)
BMI< 50.0
Disqualifiers
Regular adherent CPAP use per clinical guidelines
Any history of bleeding disorders
Current use of anti-coagulant medication
Hemoglobin <11.6 g/dL
Trial design
Design model
Crossover
Treatments tested in this trial
Continuous Positive Airway Pressure (CPAP)
DeviceTwo nights of CPAP treatment for OSA.
Treatment groups
10 Participants
are divided into 2 treatment groupsGroup A: TreatedActive comparator 1 intervention
Group B: UntreatedNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Complex I and II/Electron Transport System Capacity
A measure of mitochondrial function that takes a ratio of the phenotypic maximal respiration of mitochondria isolated in muscle fibers taken via biopsy relative to the maximal non-physiological respiratory capacity as determined via the maximal rate of oxygen consumption induced by a chemical uncoupler.
Time frame
Muscle biopsy will be collected during the treated condition and untreated condition. Mitochondrial function will be compared from both. These take place in a random order, 2-4 weeks apart.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov