Obstructive Sleep Apnea (OSA), Sleepiness, and Activity in Diabetes Management
OSA_DM
OSA, Sleepiness, and Activity in Diabetes Management
1 other identifier
interventional
23
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Apr 2009
Typical duration for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 3, 2008
CompletedFirst Posted
Study publicly available on registry
December 4, 2008
CompletedStudy Start
First participant enrolled
April 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2012
CompletedResults Posted
Study results publicly available
March 27, 2014
CompletedNovember 8, 2017
November 1, 2017
3 years
December 3, 2008
February 11, 2014
November 6, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Physical Activity, Steps Walked
Steps walked measured by the Bodymedia SenseWear Pro Armband®Data collected from the main study period
after one-month treatment
Secondary Outcomes (5)
Fructosamine
after one-month
Change in Sleep Quality
after one month
Change in Daytime Sleepiness During Main Study Period
after one month
Change in Vigor-Activity During Main Study Period
after one month
Fatigue/Inertia
after one month
Study Arms (2)
1 subjects treated with CPAP
ACTIVE COMPARATORContinuous Positive Airway Pressure treatment (CPAP)
2 subjects treated with sham-CPAP
SHAM COMPARATORSham Continuous Positive Airway Pressure treatment (sham-CPAP)
Interventions
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).
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Pittsburgh
Pittsburgh, Pennsylvania, 15261, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- E. Chasens, PhD
- Organization
- University of Pittsburgh
Study Officials
- PRINCIPAL INVESTIGATOR
Eileen R. Chasens, DSN
University of Pittsburgh
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- The mask and equipment appeared similar to actual CPAP but does not give pressure required to prevent OSA. Only CPAP naive persons eligible.
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
December 3, 2008
First Posted
December 4, 2008
Study Start
April 1, 2009
Primary Completion
April 1, 2012
Study Completion
April 1, 2012
Last Updated
November 8, 2017
Results First Posted
March 27, 2014
Record last verified: 2017-11