Diabetes Mellitus, Type 2, Sleep Apnea, Obstructive
Conditions
Keywords
daytime sleepiness, obstructive sleep apnea, type 2 diabetes mellitus, diabetes management
Brief 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.
Interventions
DEVICEContinuous Positive Airway Pressure (CPAP)
Mask worn over nose to splint open the airway with positive pressure to prevent the subject from holding their breath (apneas).
DEVICESham- Continuous Positive Airway Pressure (Sham-CPAP)
Mask worn over nose to splint open the airway with positive pressure to prevent the subject from holding their breath (apneas).
Sponsors
Eileen R. Chasens
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
The mask and equipment appeared similar to actual CPAP but does not give pressure required to prevent OSA. Only CPAP naive persons eligible.
Intervention model description
Participants on sham-CPAP were allowed to try actual CPAP.
Eligibility
Sex/Gender
ALL
Age
40 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* T2DM (verified by primary care provider (PCP) or medication for T2DM) * AHI (from PSG) greater than \> 15 * A1c \< 9.0% * Epworth Sleepiness Sca;e \> 10 (Baseline Assessment) * Able to ambulate independently or with a cane * Age 40-65 years * BMI\< 45 * No acute medical and psychiatric illness in past 3 months * Self-reported sleep duration of at least 6 hours * No changes in medications, including diabetic medications, in last 3 months * Telephone access * Able to perform study tests (e.g., speak, read and write in English) * Willing to be randomized to CPAP or sham-CPAP
Exclusion criteria
* Diagnosis of another sleep disorder, in addition to OSA, * Oxygen or Bi-level positive airway pressure required for treatment of OSA * An oxygen saturation \<75% for \>10% of the diagnostic PSG or if subject has oxygen saturation \<75% for \>25% of the first 4 h of the diagnostic PSG * Any individual in the household currently or with history of CPAP treatment * Type 1 or gestational diabetes * Prescribed insulin for treatment of type 2 diabetes * Regular use (\> 3 times/week) of hypnotic or alerting medications * History of a near-miss or automobile accident due to sleepiness * Employed in transportation-related safety sensitive occupation such as an airline pilot, truck driver, or train engineer * Currently working night or rotating shifts * Routine consumption of alcohol as determined by \>2 drinks day * Known allergy to medical adhesives or dermatological conditions that would preclude wearing CGMS * Swim or water aerobics \>once a week * Participation in contact sports or activity that may damage CGMS device or cause injury from monitor * Claustrophobia that prevents wearing the CPAP mask * Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Physical Activity, Steps Walked | after one-month treatment | Steps walked measured by the Bodymedia SenseWear Pro Armband®Data collected from the main study period |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fructosamine | after one-month | Change in fructosamine level from baseline to one month: data from main study period |
| Change in Sleep Quality | after one month | From Pittsburgh Sleep Quality Index; scores range from 0 to 21 with higher scores worse sleep quality; data from main study period |
| Change in Daytime Sleepiness During Main Study Period | after one month | Daytime Sleepiness measured by the Epworth Sleepiness Scale; measured from 0 to 24; higher scores indicate worse sleepiness |
| Change in Vigor-Activity During Main Study Period | after one month | Vigor-Activity from Profiles of Mood Scale; scores range from 0 to 32 with higher scores indicating higher vigor/activity |
| Fatigue/Inertia | after one month | Fatigue/Inertia from the Profile of Moods Subscale; scores range from 0 to 28; higher scores indicate more fatigue/inertia |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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). | 12 |
| 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). | 11 |
| Total | 23 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Main Study Period | Withdrawal by Subject | 0 | 1 |
| Sham Crossover Period | Lost to Follow-up | 0 | 2 |
Baseline characteristics
| Characteristic | 2=Subjects With T2DM and OSA Who Are Treated With Sham-CPAP | Total | 1=Subjects With T2DM and OSA Who Are Treated With CPAP |
|---|---|---|---|
| Age, Continuous | 53.45 years STANDARD_DEVIATION 10.33 | 55.6 years STANDARD_DEVIATION 10.6 | 57.58 years STANDARD_DEVIATION 10.98 |
| BMI | 34.8 kg/m2 STANDARD_DEVIATION 5.6 | 35.5 kg/m2 STANDARD_DEVIATION 6.2 | 36.2 kg/m2 STANDARD_DEVIATION 6.9 |
| Education | 14.4 years STANDARD_DEVIATION 2.9 | 14.1 years STANDARD_DEVIATION 3.2 | 13.9 years STANDARD_DEVIATION 3.5 |
| Region of Enrollment United States | 11 participants | 23 participants | 12 participants |
| Sex: Female, Male Female | 4 Participants | 9 Participants | 5 Participants |
| Sex: Female, Male Male | 7 Participants | 14 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 12 | 0 / 11 |
| serious Total, serious adverse events | 0 / 12 | 0 / 11 |
Outcome results
Primary
Physical Activity, Steps Walked
Steps walked measured by the Bodymedia SenseWear Pro Armband®Data collected from the main study period
Time frame: after one-month treatment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 1=Subjects With T2DM and OSA Who Are Treated With CPAP | Physical Activity, Steps Walked | Baseline | 5892 steps walked | Standard Deviation 3841 |
| 1=Subjects With T2DM and OSA Who Are Treated With CPAP | Physical Activity, Steps Walked | After one month | 6284 steps walked | Standard Deviation 3480 |
| 2=Subjects With T2DM and OSA Who Are Treated With Sham-CPAP | Physical Activity, Steps Walked | Baseline | 6071 steps walked | Standard Deviation 2714 |
| 2=Subjects With T2DM and OSA Who Are Treated With Sham-CPAP | Physical Activity, Steps Walked | After one month | 6684 steps walked | Standard Deviation 2509 |
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
Time frame: after one month
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 1=Subjects With T2DM and OSA Who Are Treated With CPAP | Change in Daytime Sleepiness During Main Study Period | Baseline | 11.42 units on a scale | Standard Deviation 4.6 |
| 1=Subjects With T2DM and OSA Who Are Treated With CPAP | Change in Daytime Sleepiness During Main Study Period | After one month | 9.08 units on a scale | Standard Deviation 5.7 |
| 2=Subjects With T2DM and OSA Who Are Treated With Sham-CPAP | Change in Daytime Sleepiness During Main Study Period | Baseline | 10.55 units on a scale | Standard Deviation 3.7 |
| 2=Subjects With T2DM and OSA Who Are Treated With Sham-CPAP | Change in Daytime Sleepiness During Main Study Period | After one month | 10.50 units on a scale | Standard Deviation 3.6 |
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
Time frame: after one month
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 1=Subjects With T2DM and OSA Who Are Treated With CPAP | Change in Sleep Quality | Baseline | 10.33 units on a scale | Standard Deviation 3.12 |
| 1=Subjects With T2DM and OSA Who Are Treated With CPAP | Change in Sleep Quality | One Month | 7.63 units on a scale | Standard Deviation 3.96 |
| 2=Subjects With T2DM and OSA Who Are Treated With Sham-CPAP | Change in Sleep Quality | Baseline | 10.44 units on a scale | Standard Deviation 5.29 |
| 2=Subjects With T2DM and OSA Who Are Treated With Sham-CPAP | Change in Sleep Quality | One Month | 9.78 units on a scale | Standard Deviation 3.7 |
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
Time frame: after one month
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 1=Subjects With T2DM and OSA Who Are Treated With CPAP | Change in Vigor-Activity During Main Study Period | Baseline | 15.08 units on a scale | Standard Deviation 5.16 |
| 1=Subjects With T2DM and OSA Who Are Treated With CPAP | Change in Vigor-Activity During Main Study Period | One Month | 16.75 units on a scale | Standard Deviation 6.63 |
| 2=Subjects With T2DM and OSA Who Are Treated With Sham-CPAP | Change in Vigor-Activity During Main Study Period | Baseline | 17.45 units on a scale | Standard Deviation 7.02 |
| 2=Subjects With T2DM and OSA Who Are Treated With Sham-CPAP | Change in Vigor-Activity During Main Study Period | One Month | 10.70 units on a scale | Standard Deviation 5.23 |
Secondary
Fatigue/Inertia
Fatigue/Inertia from the Profile of Moods Subscale; scores range from 0 to 28; higher scores indicate more fatigue/inertia
Time frame: after one month
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 1=Subjects With T2DM and OSA Who Are Treated With CPAP | Fatigue/Inertia | Baseline | 11.75 units on a scale | Standard Deviation 4.3 |
| 1=Subjects With T2DM and OSA Who Are Treated With CPAP | Fatigue/Inertia | One Month | 9.08 units on a scale | Standard Deviation 6.19 |
| 2=Subjects With T2DM and OSA Who Are Treated With Sham-CPAP | Fatigue/Inertia | Baseline | 9.36 units on a scale | Standard Deviation 6.04 |
| 2=Subjects With T2DM and OSA Who Are Treated With Sham-CPAP | Fatigue/Inertia | One Month | 10.70 units on a scale | Standard Deviation 5.23 |
Secondary
Fructosamine
Change in fructosamine level from baseline to one month: data from main study period
Time frame: after one-month
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 1=Subjects With T2DM and OSA Who Are Treated With CPAP | Fructosamine | Baseline | 261 umol/L | Standard Deviation 37 |
| 1=Subjects With T2DM and OSA Who Are Treated With CPAP | Fructosamine | One Month | 253 umol/L | Standard Deviation 42 |
| 2=Subjects With T2DM and OSA Who Are Treated With Sham-CPAP | Fructosamine | Baseline | 267 umol/L | Standard Deviation 44 |
| 2=Subjects With T2DM and OSA Who Are Treated With Sham-CPAP | Fructosamine | One Month | 270 umol/L | Standard Deviation 48 |