Phase 3
N=23
Obstructive Sleep Apnea (OSA), Sleepiness, and Activity in Diabetes Management
Sleep Apnea, Obstructive · Diabetes Mellitus, Type 2
Bottom Line
View on ClinicalTrials.gov: NCT00801892 ↗Enrolled (actual)
23
Serious AEs
0.0%
Results posted
Mar 2014
Primary outcome: Primary: Physical Activity, Steps Walked — 5892; 6071; 6284; 6684 steps walked
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Continuous Positive Airway Pressure (CPAP) (Device); Sham- Continuous Positive Airway Pressure (Sham-CPAP) (Device)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- Eileen R. Chasens
- Primary completion
- Apr 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Physical Activity, Steps Walked |
5892; 6071; 6284; 6684 | — |
| SECONDARY Fructosamine |
261; 267; 253; 270 | — |
| SECONDARY Change in Sleep Quality |
10.33; 10.44; 7.63; 9.78 | — |
| SECONDARY Change in Daytime Sleepiness During Main Study Period |
11.42; 10.55; 9.08; 10.50 | — |
| SECONDARY Change in Vigor-Activity During Main Study Period |
15.08; 17.45; 16.75; 10.70 | — |
| SECONDARY Fatigue/Inertia |
11.75; 9.36; 9.08; 10.70 | — |
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.
Eligibility Criteria
Inclusion Criteria
- T2DM (verified by primary care provider (PCP) or medication for T2DM)
- AHI (from PSG) greater than > 15
- A1c 10 (Baseline Assessment)
- Able to ambulate independently or with a cane
- Age 40-65 years
- BMI 10% of the diagnostic PSG or if subject has oxygen saturation 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
Data sourced from ClinicalTrials.gov (NCT00801892). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.