Obstructive Sleep Apnea (OSA), Sleepiness, and Activity in Diabetes Management
Condition: Sleep Apnea, Obstructive; Diabetes Mellitus, Type 2
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Diabetes Mellitus; Diabetes Mellitus, Type 2; Sleepiness
Study type: Interventional
Phase: Phase 3

Summary: 
      Daily physical activity is important to achieve glucose control in persons with type 2
      diabetes. The purpose of this study is to explore if obstructive sleep apnea and its daytime
      symptom, excessive sleepiness, act as barriers to physical activity. We will examine if
      treatment of obstructive sleep apnea with continuous positive airway pressure results in
      increased physical activity in persons with type 2 diabetes.
    

Detailed description: 
      Obstructive sleep apnea (OSA) is a serious disorder characterized by episodic obstruction of
      the pharyngeal airway accompanied by cessation or reduction in airflow. Untreated OSA has a
      negative impact 24 hours a day, disrupting nighttime sleep and causing excessive daytime
      sleepiness that interferes with functioning. Recent studies suggest that OSA and type 2
      diabetes (T2DM) not only co-exist but that OSA may adversely affect glucose homeostasis.
      While physical activity is recognized as beneficial to persons with T2DM, OSA severity or
      daytime sleepiness may act to hinder persons with T2DM from participating in physical
      activity. The primary aim of this pilot/feasibility study is to obtain preliminary data to
      facilitate further hypothesis development and enhance the feasibility of conducting a double
      blind, randomized, placebo-controlled study to examine physical activity in subjects with
      T2DM and OSA who are treated with CPAP compared to subjects on sham-CPAP. The secondary aims
      are to explore: 1) the interrelationships of OSA severity, daytime sleepiness, and physical
      activity on glucose variability at baseline; 2) average pre-post therapy changes in glucose
      variability in subjects treated with CPAP compared to subjects receiving sham-CPAP, and 3)
      pre to post therapy changes in weight, diet, residual sleepiness and mood in subjects treated
      with CPAP compared to subjects receiving sham-CPAP.

      The primary endpoint of the study, physical activity, will be measured by the Bodymedia
      SenseWear Pro Armband® to determine activity counts. The endpoint for glucose variability
      will be measured by the Medtronic Continuous Glucose Monitoring System (CGMS). Adherence to
      CPAP will be measured by a Smart Card® inserted in subjects' CPAP machines. We will limit the
      sample of subjects who are randomized to CPAP or sham-CPAP to persons with an adequate sleep
      duration pre-treatment (> 6 hours), with moderate or severe OSA and with EDS to have a more
      homogenous, profoundly affected sample for this pilot study. The information that will result
      from the proposed study on of the effect of OSA and EDS on glucose variability has the
      potential to lead to the development of improved behavioral interventions in persons with
      diabetes. In addition, this study contains measures of diet and mood to begin to elucidate
      the possible effects of OSA and EDS on diabetes management.
    

Intervention name(s): Continuous Positive Airway Pressure (CPAP); Sham- Continuous Positive Airway Pressure (Sham-CPAP)
Intervention type(s): Device; Device
Intervention description(s): Mask worn over nose to splint open the airway with positive pressure to prevent the subject from holding their breath (apneas).; Mask worn over nose to splint open the airway with positive pressure to prevent the subject from holding their breath (apneas).
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Participants on sham-CPAP were allowed to try actual CPAP.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Health Services Research
Keywords: daytime sleepiness; obstructive sleep apnea; type 2 diabetes mellitus; diabetes management