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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 subjects treated with CPAP | Active Comparator | Continuous Positive Airway Pressure treatment (CPAP) |
|
| 2 subjects treated with sham-CPAP | Sham Comparator | Sham Continuous Positive Airway Pressure treatment (sham-CPAP) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Continuous Positive Airway Pressure (CPAP) | Device | Mask worn over nose to splint open the airway with positive pressure to prevent the subject from holding their breath (apneas). |
| Measure | Description | Time Frame |
|---|---|---|
| Physical Activity, Steps Walked | Steps walked measured by the Bodymedia SenseWear Pro Armband®Data collected from the main study period | after one-month treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Fructosamine | Change in fructosamine level from baseline to one month: data from main study period | after one-month |
| Change in Sleep Quality | From Pittsburgh Sleep Quality Index; scores range from 0 to 21 with higher scores worse sleep quality; data from main study period |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eileen R. Chasens, DSN | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pittsburgh | Pittsburgh | Pennsylvania | 15261 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 1=Subjects With T2DM and OSA Who Are Treated With CPAP | subjects with T2DM and OSA who are treated with CPAP Continuous Positive Airway Pressure (CPAP): Worn over nose to splint open the airway and prevent the subject from holding their breath (apneas). |
| FG001 | 2=Sham-CPAP Then Active CPAP | subjects with T2DM and OSA who are treated with sham-CPAP originally; they were then allowed to cross over to the active CPAP after the main period Sham- Continuous Positive Airway Pressure (Sham-CPAP): Worn over nose to splint open the airway and prevent the subject from holding their breath (apneas). |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Main Study Period |
|
| ||||||||||||||||||
| Sham Crossover Period |
|
Sample primarily middle aged adults with type 2 diabetes
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| ID | Title | Description |
|---|---|---|
| BG000 | 1=Subjects With T2DM and OSA Who Are Treated With CPAP | subjects with T2DM and OSA who are treated with CPAP Continuous Positive Airway Pressure (CPAP): Worn over nose to splint open the airway and prevent the subject from holding their breath (apneas). |
| BG001 | 2=Subjects With T2DM and OSA Who Are Treated With Sham-CPAP |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Physical Activity, Steps Walked | Steps walked measured by the Bodymedia SenseWear Pro Armband®Data collected from the main study period | Posted | Mean | Standard Deviation | steps walked | after one-month treatment |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 1 Subjects With T2DM and OSA Who Are Treated With CPAP | subjects with T2DM and OSA who are treated with CPAP 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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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| E. Chasens, PhD | University of Pittsburgh | 412-624-9380 | chasense@pitt.edu |
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| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| D003924 | Diabetes Mellitus, Type 2 |
| D006970 | Disorders of Excessive Somnolence |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D045422 | Continuous Positive Airway Pressure |
| ID | Term |
|---|---|
| D011175 | Positive-Pressure Respiration |
| D012121 | Respiration, Artificial |
| D058109 | Airway Management |
| D013812 | Therapeutics |
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Participants on sham-CPAP were allowed to try actual CPAP.
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The mask and equipment appeared similar to actual CPAP but does not give pressure required to prevent OSA. Only CPAP naive persons eligible.
| Sham- Continuous Positive Airway Pressure (Sham-CPAP) | Device | Mask worn over nose to splint open the airway with positive pressure to prevent the subject from holding their breath (apneas). |
|
| after one month |
| Change in Daytime Sleepiness During Main Study Period | Daytime Sleepiness measured by the Epworth Sleepiness Scale; measured from 0 to 24; higher scores indicate worse sleepiness | after one month |
| Change in Vigor-Activity During Main Study Period | Vigor-Activity from Profiles of Mood Scale; scores range from 0 to 32 with higher scores indicating higher vigor/activity | after one month |
| Fatigue/Inertia | Fatigue/Inertia from the Profile of Moods Subscale; scores range from 0 to 28; higher scores indicate more fatigue/inertia | after one month |
| NOT COMPLETED |
|
|
subjects with T2DM and OSA who are treated with sham-CPAP Sham- Continuous Positive Airway Pressure (Sham-CPAP): Worn over nose to splint open the airway and prevent the subject from holding their breath (apneas). |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| BMI | Mean | Standard Deviation | kg/m2 |
|
| Education | Mean | Standard Deviation | years |
|
|
|
| Secondary | Fructosamine | Change in fructosamine level from baseline to one month: data from main study period | Posted | Mean | Standard Deviation | umol/L | after one-month |
|
|
|
| Secondary | Change in Sleep Quality | From Pittsburgh Sleep Quality Index; scores range from 0 to 21 with higher scores worse sleep quality; data from main study period | Posted | Mean | Standard Deviation | units on a scale | after one month |
|
|
|
| Secondary | Change in Daytime Sleepiness During Main Study Period | Daytime Sleepiness measured by the Epworth Sleepiness Scale; measured from 0 to 24; higher scores indicate worse sleepiness | Posted | Mean | Standard Deviation | units on a scale | after one month |
|
|
|
| Secondary | Change in Vigor-Activity During Main Study Period | Vigor-Activity from Profiles of Mood Scale; scores range from 0 to 32 with higher scores indicating higher vigor/activity | Posted | Mean | Standard Deviation | units on a scale | after one month |
|
|
|
| Secondary | Fatigue/Inertia | Fatigue/Inertia from the Profile of Moods Subscale; scores range from 0 to 28; higher scores indicate more fatigue/inertia | Posted | Mean | Standard Deviation | units on a scale | after one month |
|
|
|
| 0 |
| 12 |
| 0 |
| 12 |
| EG001 | 2 = Subjects With T2DM and OSA Who Are Treated With Sham-CPAP | subjects with T2DM and OSA who are treated with sham-CPAP Sham- Continuous Positive Airway Pressure (Sham-CPAP): Worn over nose to splint open the airway and prevent the subject from holding their breath (apneas). | 0 | 11 | 0 | 11 |
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| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D001523 | Mental Disorders |
| D012138 |
| Respiratory Therapy |