Obstructive Sleep Apnea and Glucose Metabolism (OSAGM)
Sleep Apnea, Glucose Metabolism Disorders
About this trial
This is an interventional treatment trial for Sleep Apnea focused on measuring Obstructive Sleep Apnea, Glucose Metabolism
Eligibility Criteria
General Inclusion Criteria (for all subjects):
- Age: ≥30 and ≤70 years,
- BMI: ≥30 and ≤45 kg/m2 or body fat ≥ 30 % for women and ≥ 25 % for men,
- Maximum body circumference <170 cm
- Weight stable (≤2% change)
- Untrained (≤1 h of structured exercise/wk) for at least 3 months before entering the study
- No diabetes (fasting blood glucose <126 mg/dl, 2h oral glucose tolerance test (OGTT) glucose <200 mg/dl, HbA1c ≤6.5%)
Sleep-related inclusion criteria:
Subjects without OSA:
- AHI <5/h of sleep;
- Oxygen desaturation index <3/h
- No known sleep disorders and periodic limb movement arousal index <15/h during polysomnography
- Reported sleep duration ≥6 h per night
- Regular sleep schedules (i.e. bedtime between 8 pm and 12 am and wake-time between 4 am and 8 am on all days of the week)
Subjects with OSA
- AHI ≥10/h of sleep (i.e., moderate to severe OSA)
- Oxygen desaturation index ≥4/h;
- No polysomnogram finding that would trigger immediate PAP treatment as per standard operating protocol in our sleep medicine center (a single SaO2 <50%, SaO2 <70% for >2 minutes, electrocardiogram pause >5 sec, or ventricular tachycardia >30 sec), because of the risk of a potentially adverse outcome if they are not randomized to the PAP group
- Periodic limb movement arousal index <15/h during polysomnography,
- Reported sleep duration ≥6 h per night,
- Regular night-time sleep schedules, defined as bedtime between 8 pm and 12 am and wake-time between 4 am and 8 am on all days of the week.
General Exclusion Criteria (for all subjects):
- Current treatment for previously diagnosed OSA;
- Self-reported severe difficulty sleeping in unfamiliar environments;
- Metal implants that are incompatible with magnetic resonance imaging;
- Controlled substances, tobacco products, dietary supplements, or medications known or suspected to affect sleep, breathing, upper airway muscle physiology, or glucose metabolism
- Evidence of disease (e.g., diabetes, congestive heart failure; chronic obstructive pulmonary disease; hypoventilation, defined as daytime partial pressure of carbon dioxide (pCO2) >45 mm Hg; major neurological or neuromuscular disorders; cancer; uncontrolled hypertension; etc.);
- Contraindications to supplemental oxygen or PAP (e.g., recent trans-sphenoidal surgery).
- Unwillingness or inability to provide informed consent
- Study physician considers subject to be unable to safely complete the study protocol
Sites / Locations
- Washington University School of MedicineRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Sham Comparator
No Intervention
Positive Airway Pressure (PAP)
Supplemental Oxygen (O2)
Sham
Controls
A registered polysomnographic technologist will perform a titration starting at 4 cm water (H2O) and adjust this value as needed to identify the optimal pressure to achieve an Apnea Hypopnea Index (AHI) <5 (including rapid eye movement sleep in the supine position). After PAP titration, subjects will be instructed to use the machine at the optimal pressure every night for 3 months. Compliance will be defined as: ≥4 hours use on 70% of nights and average use ≥6 hours per night.
Subjects randomized to night-time supplemental oxygen will complete an overnight oxygen titration protocol in the clinical research unit. Initially, subjects will receive 0.5 liters oxygen (O2)/min; the delivery rate will then be increased by 0.5 l/min until oxygen saturation (SaO2) is ≥88%. The optimal O2 delivery rate determined during this study will be used for the intervention. The oxygen concentrators used at home will record cumulative hours of use to provide an objective measure of adherence (monitored weekly). Compliance will be defined as ≥6 h average use per night..
Subjects in the sham treatment group will complete the oxygen titration protocol described for the night-time supplemental oxygen group, except that their oxygen concentrator will have been covertly modified to deliver room air at a rate of 0.5 l/min.
Subjects without OSA will be recruited and complete all testing for primary outcome measures, but will not undergo any intervention.