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Sponsors and Collaborators: |
University of Pittsburgh National Heart, Lung, and Blood Institute (NHLBI) |
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Information provided by: | University of Pittsburgh |
ClinicalTrials.gov Identifier: | NCT00801892 |
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.
Condition | Intervention | Phase |
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Sleep Apnea, Obstructive Diabetes Mellitus, Type 2 |
Device: Continuous Positive Airway Pressure (CPAP) Device: Sham- Continuous Positive Airway Pressure (Sham-CPAP) |
Phase IV |
Study Type: | Interventional |
Study Design: | Health Services Research, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Efficacy Study |
Official Title: | OSA, Sleepiness, and Activity in Diabetes Management |
Estimated Enrollment: | 80 |
Study Start Date: | April 2009 |
Estimated Study Completion Date: | March 2011 |
Estimated Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
subjects with T2DM and OSA who are treated with CPAP
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Device: Continuous Positive Airway Pressure (CPAP)
Worn over nose to splint open the airway and prevent the subject from holding their breath (apneas).
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2: Sham Comparator
subjects with T2DM and OSA who are treated with sham-CPAP
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Device: Sham- Continuous Positive Airway Pressure (Sham-CPAP)
Worn over nose to splint open the airway and prevent the subject from holding their breath (apneas).
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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.
Ages Eligible for Study: | 40 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Eileen R Chasens, DSN | 412-624-9380 |
United States, Pennsylvania | |
University of Pittsburgh | |
Pittsburgh, Pennsylvania, United States, 15261 |
Principal Investigator: | Eileen R. Chasens, DSN | University of Pittsburgh |
Responsible Party: | University of Pittsburgh ( Eileen R. Chasens ) |
Study ID Numbers: | R21 HL089522-01A2 |
Study First Received: | December 3, 2008 |
Last Updated: | December 3, 2008 |
ClinicalTrials.gov Identifier: | NCT00801892 History of Changes |
Health Authority: | United States: Institutional Review Board |
daytime sleepiness obstructive sleep apnea type 2 diabetes mellitus diabetes management |
Sleep Apnea Syndromes Metabolic Diseases Apnea Sleep Apnea, Obstructive Respiration Disorders Diabetes Mellitus Dyssomnias Endocrine System Diseases Sleep Disorders |
Sleep Disorders, Intrinsic Signs and Symptoms Respiratory Tract Diseases Diabetes Mellitus, Type 2 Signs and Symptoms, Respiratory Endocrinopathy Glucose Metabolism Disorders Metabolic Disorder |
Sleep Apnea Syndromes Metabolic Diseases Apnea Nervous System Diseases Sleep Apnea, Obstructive Respiration Disorders Diabetes Mellitus Sleep Disorders |
Dyssomnias Endocrine System Diseases Sleep Disorders, Intrinsic Signs and Symptoms Respiratory Tract Diseases Diabetes Mellitus, Type 2 Signs and Symptoms, Respiratory Glucose Metabolism Disorders |