Trial Outcomes & Findings for Obstructive Sleep Apnea (OSA), Sleepiness, and Activity in Diabetes Management (NCT NCT00801892)
NCT ID: NCT00801892
Last Updated: 2017-11-08
Results Overview
Steps walked measured by the Bodymedia SenseWear Pro Armband®Data collected from the main study period
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
23 participants
Primary outcome timeframe
after one-month treatment
Results posted on
2017-11-08
Participant Flow
Participant milestones
| Measure |
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).
|
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).
|
|---|---|---|
|
Main Study Period
STARTED
|
12
|
11
|
|
Main Study Period
COMPLETED
|
12
|
10
|
|
Main Study Period
NOT COMPLETED
|
0
|
1
|
|
Sham Crossover Period
STARTED
|
0
|
7
|
|
Sham Crossover Period
COMPLETED
|
0
|
5
|
|
Sham Crossover Period
NOT COMPLETED
|
0
|
2
|
Reasons for withdrawal
| Measure |
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).
|
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).
|
|---|---|---|
|
Main Study Period
Withdrawal by Subject
|
0
|
1
|
|
Sham Crossover Period
Lost to Follow-up
|
0
|
2
|
Baseline Characteristics
Obstructive Sleep Apnea (OSA), Sleepiness, and Activity in Diabetes Management
Baseline characteristics by cohort
| Measure |
1=Subjects With T2DM and OSA Who Are Treated With CPAP
n=12 Participants
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).
|
2=Subjects With T2DM and OSA Who Are Treated With Sham-CPAP
n=11 Participants
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).
|
Total
n=23 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57.58 years
STANDARD_DEVIATION 10.98 • n=5 Participants
|
53.45 years
STANDARD_DEVIATION 10.33 • n=7 Participants
|
55.6 years
STANDARD_DEVIATION 10.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
12 participants
n=5 Participants
|
11 participants
n=7 Participants
|
23 participants
n=5 Participants
|
|
BMI
|
36.2 kg/m2
STANDARD_DEVIATION 6.9 • n=5 Participants
|
34.8 kg/m2
STANDARD_DEVIATION 5.6 • n=7 Participants
|
35.5 kg/m2
STANDARD_DEVIATION 6.2 • n=5 Participants
|
|
Education
|
13.9 years
STANDARD_DEVIATION 3.5 • n=5 Participants
|
14.4 years
STANDARD_DEVIATION 2.9 • n=7 Participants
|
14.1 years
STANDARD_DEVIATION 3.2 • n=5 Participants
|
PRIMARY outcome
Timeframe: after one-month treatmentSteps walked measured by the Bodymedia SenseWear Pro Armband®Data collected from the main study period
Outcome measures
| Measure |
1=Subjects With T2DM and OSA Who Are Treated With CPAP
n=12 Participants
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).
|
2=Subjects With T2DM and OSA Who Are Treated With Sham-CPAP
n=11 Participants
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).
|
|---|---|---|
|
Physical Activity, Steps Walked
Baseline
|
5892 steps walked
Standard Deviation 3841
|
6071 steps walked
Standard Deviation 2714
|
|
Physical Activity, Steps Walked
After one month
|
6284 steps walked
Standard Deviation 3480
|
6684 steps walked
Standard Deviation 2509
|
SECONDARY outcome
Timeframe: after one-monthChange in fructosamine level from baseline to one month: data from main study period
Outcome measures
| Measure |
1=Subjects With T2DM and OSA Who Are Treated With CPAP
n=12 Participants
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).
|
2=Subjects With T2DM and OSA Who Are Treated With Sham-CPAP
n=10 Participants
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).
|
|---|---|---|
|
Fructosamine
Baseline
|
261 umol/L
Standard Deviation 37
|
267 umol/L
Standard Deviation 44
|
|
Fructosamine
One Month
|
253 umol/L
Standard Deviation 42
|
270 umol/L
Standard Deviation 48
|
SECONDARY outcome
Timeframe: after one monthFrom Pittsburgh Sleep Quality Index; scores range from 0 to 21 with higher scores worse sleep quality; data from main study period
Outcome measures
| Measure |
1=Subjects With T2DM and OSA Who Are Treated With CPAP
n=12 Participants
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).
|
2=Subjects With T2DM and OSA Who Are Treated With Sham-CPAP
n=11 Participants
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).
|
|---|---|---|
|
Change in Sleep Quality
Baseline
|
10.33 units on a scale
Standard Deviation 3.12
|
10.44 units on a scale
Standard Deviation 5.29
|
|
Change in Sleep Quality
One Month
|
7.63 units on a scale
Standard Deviation 3.96
|
9.78 units on a scale
Standard Deviation 3.70
|
SECONDARY outcome
Timeframe: after one monthDaytime Sleepiness measured by the Epworth Sleepiness Scale; measured from 0 to 24; higher scores indicate worse sleepiness
Outcome measures
| Measure |
1=Subjects With T2DM and OSA Who Are Treated With CPAP
n=12 Participants
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).
|
2=Subjects With T2DM and OSA Who Are Treated With Sham-CPAP
n=11 Participants
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).
|
|---|---|---|
|
Change in Daytime Sleepiness During Main Study Period
Baseline
|
11.42 units on a scale
Standard Deviation 4.6
|
10.55 units on a scale
Standard Deviation 3.7
|
|
Change in Daytime Sleepiness During Main Study Period
After one month
|
9.08 units on a scale
Standard Deviation 5.7
|
10.50 units on a scale
Standard Deviation 3.6
|
SECONDARY outcome
Timeframe: after one monthVigor-Activity from Profiles of Mood Scale; scores range from 0 to 32 with higher scores indicating higher vigor/activity
Outcome measures
| Measure |
1=Subjects With T2DM and OSA Who Are Treated With CPAP
n=12 Participants
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).
|
2=Subjects With T2DM and OSA Who Are Treated With Sham-CPAP
n=11 Participants
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).
|
|---|---|---|
|
Change in Vigor-Activity During Main Study Period
Baseline
|
15.08 units on a scale
Standard Deviation 5.16
|
17.45 units on a scale
Standard Deviation 7.02
|
|
Change in Vigor-Activity During Main Study Period
One Month
|
16.75 units on a scale
Standard Deviation 6.63
|
10.70 units on a scale
Standard Deviation 5.23
|
SECONDARY outcome
Timeframe: after one monthFatigue/Inertia from the Profile of Moods Subscale; scores range from 0 to 28; higher scores indicate more fatigue/inertia
Outcome measures
| Measure |
1=Subjects With T2DM and OSA Who Are Treated With CPAP
n=12 Participants
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).
|
2=Subjects With T2DM and OSA Who Are Treated With Sham-CPAP
n=11 Participants
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).
|
|---|---|---|
|
Fatigue/Inertia
Baseline
|
11.75 units on a scale
Standard Deviation 4.3
|
9.36 units on a scale
Standard Deviation 6.04
|
|
Fatigue/Inertia
One Month
|
9.08 units on a scale
Standard Deviation 6.19
|
10.70 units on a scale
Standard Deviation 5.23
|
Adverse Events
1 Subjects With T2DM and OSA Who Are Treated With CPAP
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
2 = Subjects With T2DM and OSA Who Are Treated With Sham-CPAP
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place