Trial Outcomes & Findings for Diabetes-Obstructive Sleep Apnea Treatment Trial (NCT NCT01901055)
NCT ID: NCT01901055
Last Updated: 2021-08-16
Results Overview
Glycated hemoglobin test that estimates the blood glucose level over last 2 to 3 months. Higher scores indicate worse diabetes control.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
98 participants
Primary outcome timeframe
baseline, 6 weeks, 12 weeks
Results posted on
2021-08-16
Participant Flow
Participants recruitment started in 2014 and the last participant was evaluated in 2019. The total sample screened (N=862) was from the University of Pittsburgh (n=720), Veterans Administration Pittsburgh Healthcare System (n=58), West Virginial University (n=72), and the John Dingell Detroit Veterans Administration Healthcare System (n=12).
Phone assessment excluded persons with prior CPAP use, not having diagnosis of type 2 diabetes, history of a sleepiness related accident or near miss, or not ambulatory. Participants (n=355) who met the phone screening were invited for a baseline assessment. The baseline assessment excluded persons with HbA1c either \< 6.5% or \> 11%; without OSA, with too high a AHI or severe oxygen desaturations, or not interested in being randomized to sham-CPAP. 98 participants meet all eligibility criteria.
Participant milestones
| Measure |
Active CPAP Treatment
Treatment of obstructive sleep apnea with continuous positive airway pressure (CPAP)
CPAP: CPAP is a device that has a mask worn over the nose that is attached to a device that provides positive airway pressure. CPAP is worn while sleeping, it splints open the airway and prevent apneas (cessation of breathing) and hypopneas (reduced airflow while breathing).
Diabetes Education: Diabetes Education will be delivered to participants in both the CPAP group and the Sham-CPAP group. The education will be based on ADA and AADE guidelines and consist of 2 in-person sessions (90 minutes and 60 minutes) and 3 follow-up phone calls 9about 15 minutes each)
|
Sham-CPAP
Device that appears like the treatment of obstructive sleep apnea, a continuous positive airway pressure device, but that does not provide treatment.
Sham-CPAP: Sham-CPAP is a device that has a mask worn over the nose that is attached to a device that looks and sounds like CPAP however it does not provide positive airway pressure. Sham-CPAP is worn while sleeping, it does not splint open the airway and prevent apneas (cessation of breathing) and hypopneas (reduced airflow while breathing).
Diabetes Education: Diabetes Education will be delivered to participants in both the CPAP group and the Sham-CPAP group. The education will be based on ADA and AADE guidelines and consist of 2 in-person sessions (90 minutes and 60 minutes) and 3 follow-up phone calls 9about 15 minutes each)
|
|---|---|---|
|
Randomization But Not Titrated
STARTED
|
49
|
49
|
|
Randomization But Not Titrated
COMPLETED
|
48
|
47
|
|
Randomization But Not Titrated
NOT COMPLETED
|
1
|
2
|
|
Started Protocol to Week 6
STARTED
|
48
|
47
|
|
Started Protocol to Week 6
COMPLETED
|
45
|
43
|
|
Started Protocol to Week 6
NOT COMPLETED
|
3
|
4
|
|
Week 12 Assessment
STARTED
|
45
|
43
|
|
Week 12 Assessment
COMPLETED
|
44
|
39
|
|
Week 12 Assessment
NOT COMPLETED
|
1
|
4
|
|
Week 24
STARTED
|
44
|
39
|
|
Week 24
COMPLETED
|
30
|
20
|
|
Week 24
NOT COMPLETED
|
14
|
19
|
|
Week 36
STARTED
|
30
|
20
|
|
Week 36
COMPLETED
|
30
|
15
|
|
Week 36
NOT COMPLETED
|
0
|
5
|
Reasons for withdrawal
| Measure |
Active CPAP Treatment
Treatment of obstructive sleep apnea with continuous positive airway pressure (CPAP)
CPAP: CPAP is a device that has a mask worn over the nose that is attached to a device that provides positive airway pressure. CPAP is worn while sleeping, it splints open the airway and prevent apneas (cessation of breathing) and hypopneas (reduced airflow while breathing).
Diabetes Education: Diabetes Education will be delivered to participants in both the CPAP group and the Sham-CPAP group. The education will be based on ADA and AADE guidelines and consist of 2 in-person sessions (90 minutes and 60 minutes) and 3 follow-up phone calls 9about 15 minutes each)
|
Sham-CPAP
Device that appears like the treatment of obstructive sleep apnea, a continuous positive airway pressure device, but that does not provide treatment.
Sham-CPAP: Sham-CPAP is a device that has a mask worn over the nose that is attached to a device that looks and sounds like CPAP however it does not provide positive airway pressure. Sham-CPAP is worn while sleeping, it does not splint open the airway and prevent apneas (cessation of breathing) and hypopneas (reduced airflow while breathing).
Diabetes Education: Diabetes Education will be delivered to participants in both the CPAP group and the Sham-CPAP group. The education will be based on ADA and AADE guidelines and consist of 2 in-person sessions (90 minutes and 60 minutes) and 3 follow-up phone calls 9about 15 minutes each)
|
|---|---|---|
|
Randomization But Not Titrated
Did not come to titration study
|
1
|
1
|
|
Randomization But Not Titrated
Physician Decision
|
0
|
1
|
|
Started Protocol to Week 6
Physician Decision
|
2
|
1
|
|
Started Protocol to Week 6
complains of difficulty with wearing mask
|
0
|
2
|
|
Started Protocol to Week 6
Participant had not disclosed that they had been previously been on CPAP
|
1
|
0
|
|
Started Protocol to Week 6
Withdrawal by Subject
|
0
|
1
|
|
Week 12 Assessment
Medical procedure that may interfere with wearing CPAPP mask
|
1
|
0
|
|
Week 12 Assessment
Withdrawal by Subject
|
0
|
4
|
|
Week 24
Withdrawal by Subject
|
13
|
19
|
|
Week 24
Physician Decision
|
1
|
0
|
|
Week 36
Withdrawal by Subject
|
0
|
5
|
Baseline Characteristics
This measure was not done by protocol at University of West Virginia and Detroit VA; missing data at Pitt and VAPHS
Baseline characteristics by cohort
| Measure |
Active CPAP Treatment
n=49 Participants
Treatment of obstructive sleep apnea with continuous positive airway pressure (CPAP)
CPAP: CPAP is a device that has a mask worn over the nose that is attached to a device that provides positive airway pressure. CPAP is worn while sleeping, it splints open the airway and prevent apneas (cessation of breathing) and hypopneas (reduced airflow while breathing).
Diabetes Education: Diabetes Education will be delivered to participants in both the CPAP group and the Sham-CPAP group. The education will be based on ADA and AADE guidelines and consist of 2 in-person sessions (90 minutes and 60 minutes) and 3 follow-up phone calls 9about 15 minutes each)
|
Sham-CPAP
n=49 Participants
Device that appears like the treatment of obstructive sleep apnea, a continuous positive airway pressure device, but that does not provide treatment.
Sham-CPAP: Sham-CPAP is a device that has a mask worn over the nose that is attached to a device that looks and sounds like CPAP however it does not provide positive airway pressure. Sham-CPAP is worn while sleeping, it does not splint open the airway and prevent apneas (cessation of breathing) and hypopneas (reduced airflow while breathing).
Diabetes Education: Diabetes Education will be delivered to participants in both the CPAP group and the Sham-CPAP group. The education will be based on ADA and AADE guidelines and consist of 2 in-person sessions (90 minutes and 60 minutes) and 3 follow-up phone calls 9about 15 minutes each)
|
Total
n=98 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=49 Participants
|
0 Participants
n=49 Participants
|
0 Participants
n=98 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
31 Participants
n=49 Participants
|
38 Participants
n=49 Participants
|
69 Participants
n=98 Participants
|
|
Age, Categorical
>=65 years
|
18 Participants
n=49 Participants
|
11 Participants
n=49 Participants
|
29 Participants
n=98 Participants
|
|
Age, Continuous
|
60.08 years
STANDARD_DEVIATION 10.13 • n=49 Participants
|
57.37 years
STANDARD_DEVIATION 9.32 • n=49 Participants
|
58.72 years
STANDARD_DEVIATION 9.78 • n=98 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=49 Participants
|
19 Participants
n=49 Participants
|
42 Participants
n=98 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=49 Participants
|
30 Participants
n=49 Participants
|
56 Participants
n=98 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=49 Participants
|
1 Participants
n=49 Participants
|
2 Participants
n=98 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
48 Participants
n=49 Participants
|
48 Participants
n=49 Participants
|
96 Participants
n=98 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=49 Participants
|
0 Participants
n=49 Participants
|
0 Participants
n=98 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=49 Participants
|
0 Participants
n=49 Participants
|
0 Participants
n=98 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=49 Participants
|
1 Participants
n=49 Participants
|
1 Participants
n=98 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=49 Participants
|
0 Participants
n=49 Participants
|
0 Participants
n=98 Participants
|
|
Race (NIH/OMB)
Black or African American
|
13 Participants
n=49 Participants
|
8 Participants
n=49 Participants
|
21 Participants
n=98 Participants
|
|
Race (NIH/OMB)
White
|
36 Participants
n=49 Participants
|
37 Participants
n=49 Participants
|
73 Participants
n=98 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=49 Participants
|
3 Participants
n=49 Participants
|
3 Participants
n=98 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=49 Participants
|
0 Participants
n=49 Participants
|
0 Participants
n=98 Participants
|
|
Region of Enrollment
United States
|
49 participants
n=49 Participants
|
49 participants
n=49 Participants
|
98 participants
n=98 Participants
|
|
HbA1c
|
7.73 percentage of glycated hemoglobins
STANDARD_DEVIATION 0.75 • n=49 Participants
|
8.04 percentage of glycated hemoglobins
STANDARD_DEVIATION 1.01 • n=49 Participants
|
7.89 percentage of glycated hemoglobins
STANDARD_DEVIATION 0.90 • n=98 Participants
|
|
Fructosamine
|
285.10 µmol/L
STANDARD_DEVIATION 45.20 • n=41 Participants • This measure was not done by protocol at University of West Virginia and Detroit VA; missing data at Pitt and VAPHS
|
301.88 µmol/L
STANDARD_DEVIATION 54.41 • n=42 Participants • This measure was not done by protocol at University of West Virginia and Detroit VA; missing data at Pitt and VAPHS
|
293.59 µmol/L
STANDARD_DEVIATION 50.48 • n=83 Participants • This measure was not done by protocol at University of West Virginia and Detroit VA; missing data at Pitt and VAPHS
|
|
Body Mass Index (kg/m^2)
|
35.71 kg/m^2
STANDARD_DEVIATION 6.16 • n=49 Participants
|
36.69 kg/m^2
STANDARD_DEVIATION 6.99 • n=49 Participants
|
36.20 kg/m^2
STANDARD_DEVIATION 6.57 • n=98 Participants
|
|
Apnea-Hypopnea Index
|
22.48 events per hour of sleep
STANDARD_DEVIATION 13.41 • n=49 Participants
|
25.92 events per hour of sleep
STANDARD_DEVIATION 15.86 • n=49 Participants
|
24.20 events per hour of sleep
STANDARD_DEVIATION 14.71 • n=98 Participants
|
|
Epworth Sleepiness Scale
|
10.22 units on a scale
STANDARD_DEVIATION 4.36 • n=49 Participants
|
10.39 units on a scale
STANDARD_DEVIATION 4.76 • n=49 Participants
|
10.31 units on a scale
STANDARD_DEVIATION 4.54 • n=98 Participants
|
|
Pittsburgh Sleep Quality Index Total Score
|
10.00 units on a scale
STANDARD_DEVIATION 3.61 • n=49 Participants
|
9.67 units on a scale
STANDARD_DEVIATION 4.19 • n=49 Participants
|
9.84 units on a scale
STANDARD_DEVIATION 3.89 • n=98 Participants
|
PRIMARY outcome
Timeframe: baseline, 6 weeks, 12 weeksPopulation: All randomized participants were analyzed (the intention to treat method).
Glycated hemoglobin test that estimates the blood glucose level over last 2 to 3 months. Higher scores indicate worse diabetes control.
Outcome measures
| Measure |
Active CPAP Treatment
n=49 Participants
Treatment of obstructive sleep apnea with continuous positive airway pressure (CPAP)
|
Sham-CPAP Treatment
n=49 Participants
Device that appears like the treatment of obstructive sleep apnea, a continuous positive airway pressure device, but that does not provide treatment.
|
|---|---|---|
|
HbA1C Level
Baseline
|
7.73 % of glycated hemoglobin in the blood
Standard Error 0.13
|
8.04 % of glycated hemoglobin in the blood
Standard Error 0.13
|
|
HbA1C Level
6-week
|
7.49 % of glycated hemoglobin in the blood
Standard Error 0.17
|
820 % of glycated hemoglobin in the blood
Standard Error 0.17
|
|
HbA1C Level
12-week
|
7.46 % of glycated hemoglobin in the blood
Standard Error 0.15
|
7.80 % of glycated hemoglobin in the blood
Standard Error 0.16
|
SECONDARY outcome
Timeframe: baseline, 6 weeks, 12 weeksPopulation: All randomized participants with data were analyzed (the intention to treat method). Unable to obtain laboratory value on from participants from West Virginia University (n=12), Detroit (n=1), and Pitt (n=2)
Measurement of glucose in plasma that estimates the blood glucose level over last 10 days to 3 weeks. The normal range is from 221.00 to 451.00.
Outcome measures
| Measure |
Active CPAP Treatment
n=41 Participants
Treatment of obstructive sleep apnea with continuous positive airway pressure (CPAP)
|
Sham-CPAP Treatment
n=42 Participants
Device that appears like the treatment of obstructive sleep apnea, a continuous positive airway pressure device, but that does not provide treatment.
|
|---|---|---|
|
Fructosamine Level
Baseline
|
285.94 umol/L (micromols per liter)
Standard Error 7.78
|
300.99 umol/L (micromols per liter)
Standard Error 7.68
|
|
Fructosamine Level
6-week
|
272.84 umol/L (micromols per liter)
Standard Error 7.32
|
293.73 umol/L (micromols per liter)
Standard Error 7.53
|
|
Fructosamine Level
12-week
|
274.87 umol/L (micromols per liter)
Standard Error 7.53
|
285.56 umol/L (micromols per liter)
Standard Error 7.80
|
SECONDARY outcome
Timeframe: baseline, 6 weeks, 12 weeksPopulation: All randomized participants with valid data were analyzed (the intention to treat method). One participant with missing data.
Diabetes Diet Adherence score from the Summary of Diabetes Self-Care Activities (SDSCA) Questionnaire, Average number of days each week that was adherent to diabetes diet, range from minimum=0 days to maximum=7 days; higher number indicates better adherence to diabetes diet
Outcome measures
| Measure |
Active CPAP Treatment
n=49 Participants
Treatment of obstructive sleep apnea with continuous positive airway pressure (CPAP)
|
Sham-CPAP Treatment
n=48 Participants
Device that appears like the treatment of obstructive sleep apnea, a continuous positive airway pressure device, but that does not provide treatment.
|
|---|---|---|
|
Diabetes Diet Adherence
Baseline
|
3.55 Average number of days/week
Standard Error 0.29
|
3.61 Average number of days/week
Standard Error 0.30
|
|
Diabetes Diet Adherence
6-week
|
4.18 Average number of days/week
Standard Error 0.27
|
4.05 Average number of days/week
Standard Error 0.29
|
|
Diabetes Diet Adherence
12-week
|
4.30 Average number of days/week
Standard Error 0.25
|
4.05 Average number of days/week
Standard Error 0.27
|
SECONDARY outcome
Timeframe: baseline,12 weeks onlyPopulation: All randomized participants were analyzed (the intention to treat method).
Score on the Diabetes Knowledge Test. Scores range minimum=0 to maximum=100, higher scores indicate higher knowledge (this measure only done at 12 weeks)
Outcome measures
| Measure |
Active CPAP Treatment
n=49 Participants
Treatment of obstructive sleep apnea with continuous positive airway pressure (CPAP)
|
Sham-CPAP Treatment
n=49 Participants
Device that appears like the treatment of obstructive sleep apnea, a continuous positive airway pressure device, but that does not provide treatment.
|
|---|---|---|
|
Diabetes Knowledge
Baseline
|
79.39 % of correct answers
Standard Error 1.88
|
75.74 % of correct answers
Standard Error 1.88
|
|
Diabetes Knowledge
12-week
|
83.20 % of correct answers
Standard Error 1.79
|
79.81 % of correct answers
Standard Error 1.88
|
SECONDARY outcome
Timeframe: baseline, 6 weeks, 12 weeksPopulation: All randomized participants were analyzed (the intention to treat method).
SMBG score from the Summary of Diabetes Self-Care Activities (SDSCA) Questionnaire, Average number of days each week that SMBG was done, range from 0 days to 7 days; higher number indicates better SMBG
Outcome measures
| Measure |
Active CPAP Treatment
n=49 Participants
Treatment of obstructive sleep apnea with continuous positive airway pressure (CPAP)
|
Sham-CPAP Treatment
n=49 Participants
Device that appears like the treatment of obstructive sleep apnea, a continuous positive airway pressure device, but that does not provide treatment.
|
|---|---|---|
|
Self-Monitoring of Blood Glucose (SMBG)
Baseline
|
4.17 Average number of days/week
Standard Error 0.38
|
4.24 Average number of days/week
Standard Error 0.38
|
|
Self-Monitoring of Blood Glucose (SMBG)
6-week
|
5.44 Average number of days/week
Standard Error 0.31
|
5.10 Average number of days/week
Standard Error 0.33
|
|
Self-Monitoring of Blood Glucose (SMBG)
12-week
|
5.52 Average number of days/week
Standard Error 0.34
|
4.61 Average number of days/week
Standard Error 0.36
|
SECONDARY outcome
Timeframe: baseline, 6 weeks, 12 weeksPopulation: All randomized participants were analyzed (the intention to treat method).
Average number of steps walked daily; measured by BodyMedia Armband; higher numbers indicate more steps walked. The range is from 397.83 to 16839.00.
Outcome measures
| Measure |
Active CPAP Treatment
n=49 Participants
Treatment of obstructive sleep apnea with continuous positive airway pressure (CPAP)
|
Sham-CPAP Treatment
n=49 Participants
Device that appears like the treatment of obstructive sleep apnea, a continuous positive airway pressure device, but that does not provide treatment.
|
|---|---|---|
|
Steps Walked
Baseline
|
4550.83 Steps/day
Standard Error 374.15
|
4463.61 Steps/day
Standard Error 374.15
|
|
Steps Walked
6-week
|
4774.81 Steps/day
Standard Error 386.56
|
4240.42 Steps/day
Standard Error 403.84
|
|
Steps Walked
12-week
|
4741.43 Steps/day
Standard Error 355.27
|
4403.97 Steps/day
Standard Error 372.96
|
SECONDARY outcome
Timeframe: baseline, 6 weeks, 12 weeksPopulation: All randomized participants were analyzed (the intention to treat method).
Foot Care score from the Summary of Diabetes Self-Care Activities (SDSCA) Questionnaire, Average number of days each week that foot care was done, range from 0 days to 7 days; higher number indicates better adherence to foot care
Outcome measures
| Measure |
Active CPAP Treatment
n=49 Participants
Treatment of obstructive sleep apnea with continuous positive airway pressure (CPAP)
|
Sham-CPAP Treatment
n=49 Participants
Device that appears like the treatment of obstructive sleep apnea, a continuous positive airway pressure device, but that does not provide treatment.
|
|---|---|---|
|
Self-Monitoring of Foot Care
Baseline
|
3.26 Average number of days/week
Standard Error 0.35
|
3.89 Average number of days/week
Standard Error 0.35
|
|
Self-Monitoring of Foot Care
6-week
|
3.56 Average number of days/week
Standard Error 0.37
|
4.44 Average number of days/week
Standard Error 0.39
|
|
Self-Monitoring of Foot Care
12-week
|
4.18 Average number of days/week
Standard Error 0.37
|
4.57 Average number of days/week
Standard Error 0.39
|
SECONDARY outcome
Timeframe: baseline, 6 weeks, 12 weeksPopulation: All randomized participants were analyzed (the intention to treat method).
Score of the Problem Areas in Diabetes (PAID) Questionnaire; scores range from 0-100, higher scores indicate worse diabetes-related distress.
Outcome measures
| Measure |
Active CPAP Treatment
n=49 Participants
Treatment of obstructive sleep apnea with continuous positive airway pressure (CPAP)
|
Sham-CPAP Treatment
n=49 Participants
Device that appears like the treatment of obstructive sleep apnea, a continuous positive airway pressure device, but that does not provide treatment.
|
|---|---|---|
|
Diabetes-Related Distress
Baseline
|
29.18 score on a scale
Standard Error 2.77
|
26.44 score on a scale
Standard Error 2.79
|
|
Diabetes-Related Distress
6-week
|
22.75 score on a scale
Standard Error 2.72
|
20.08 score on a scale
Standard Error 2.81
|
|
Diabetes-Related Distress
12-week
|
20.7413 score on a scale
Standard Error 2.60
|
19.99 score on a scale
Standard Error 2.76
|
SECONDARY outcome
Timeframe: baseline, 6 weeks, 12 weeksPopulation: All randomized participants were analyzed (the intention to treat method).
Sleep Quality is measured by the Pittsburgh Sleep Quality Index (PSQI) - Higher scores indicate worse sleep quality. The potential range is from 0 to 27 with higher scores indicating worse sleep quality.
Outcome measures
| Measure |
Active CPAP Treatment
n=49 Participants
Treatment of obstructive sleep apnea with continuous positive airway pressure (CPAP)
|
Sham-CPAP Treatment
n=49 Participants
Device that appears like the treatment of obstructive sleep apnea, a continuous positive airway pressure device, but that does not provide treatment.
|
|---|---|---|
|
Sleep Quality
6-week
|
8.12 score on a scale
Standard Error 0.52
|
8.57 score on a scale
Standard Error 0.54
|
|
Sleep Quality
Baseline
|
10.00 score on a scale
Standard Error 0.56
|
9.67 score on a scale
Standard Error 0.56
|
|
Sleep Quality
12-week
|
8.77 score on a scale
Standard Error 0.55
|
8.54 score on a scale
Standard Error 0.59
|
SECONDARY outcome
Timeframe: baseline, 6 weeks, 12 weeksPopulation: All randomized participants were analyzed (the intention to treat method).
Mood impairment measured by the Profile of Mood States (POMS) total score; potential scores range from 0 to 60; higher scores indicate worse mood.
Outcome measures
| Measure |
Active CPAP Treatment
n=49 Participants
Treatment of obstructive sleep apnea with continuous positive airway pressure (CPAP)
|
Sham-CPAP Treatment
n=49 Participants
Device that appears like the treatment of obstructive sleep apnea, a continuous positive airway pressure device, but that does not provide treatment.
|
|---|---|---|
|
Mood
Baseline
|
28.94 score on a scale
Standard Error 5.12
|
25.76 score on a scale
Standard Error 5.12
|
|
Mood
6-week
|
17.28 score on a scale
Standard Error 5.35
|
23.17 score on a scale
Standard Error 5.49
|
|
Mood
12-week
|
19.32 score on a scale
Standard Error 5.85
|
22.61 score on a scale
Standard Error 6.10
|
SECONDARY outcome
Timeframe: Administered during diabetes education sessions done within the first 6 weeks of study; baseline, approximately 3 weeks after starting CPAP, and at the 2nd diabetes education sessionPopulation: All randomized participants with data were were analyzed (the intention to treat method). This measure was not done per site protocol at West Virginia (n=12) and Detroit (n=1)), missing data from participants at Pittsburgh and VA Pittsburgh sites (n=29).
Ability to maintain attention (i.e. vigilance); Measured by the Psychomotor Vigilance Test primary metric being transformed lapses (i.e. when person does not respond to a visual stimuli in a reaction time test). Normal values are \<=2 lapses within the 10 minute test. Higher scores indicate worse vigilance.
Outcome measures
| Measure |
Active CPAP Treatment
n=33 Participants
Treatment of obstructive sleep apnea with continuous positive airway pressure (CPAP)
|
Sham-CPAP Treatment
n=33 Participants
Device that appears like the treatment of obstructive sleep apnea, a continuous positive airway pressure device, but that does not provide treatment.
|
|---|---|---|
|
Vigilance
Baseline
|
4.68 transformed lapses
Standard Error 0.45
|
4.67 transformed lapses
Standard Error 0.45
|
|
Vigilance
Average Lapses First Diabetes Session
|
4.30 transformed lapses
Standard Error 0.47
|
3.56 transformed lapses
Standard Error 0.47
|
|
Vigilance
Average lapses 2nd Diabetes Education Session
|
3.59 transformed lapses
Standard Error 0.54
|
4.78 transformed lapses
Standard Error 0.54
|
Adverse Events
Active CPAP Treatment
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Sham-CPAP
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Active CPAP Following Sham-CPAP
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Active CPAP Treatment
n=49 participants at risk
Treatment of obstructive sleep apnea with continuous positive airway pressure (CPAP)
CPAP: CPAP is a device that has a mask worn over the nose that is attached to a device that provides positive airway pressure. CPAP is worn while sleeping, it splints open the airway and prevent apneas (cessation of breathing) and hypopneas (reduced airflow while breathing).
Diabetes Education: Diabetes Education will be delivered to participants in both the CPAP group and the Sham-CPAP group. The education will be based on ADA and AADE guidelines and consist of 2 in-person sessions (90 minutes and 60 minutes) and 3 follow-up phone calls 9about 15 minutes each)
|
Sham-CPAP
n=49 participants at risk
Device that appears like the treatment of obstructive sleep apnea, a continuous positive airway pressure device, but that does not provide treatment.
Sham-CPAP: Sham-CPAP is a device that has a mask worn over the nose that is attached to a device that looks and sounds like CPAP however it does not provide positive airway pressure. Sham-CPAP is worn while sleeping, it does not splint open the airway and prevent apneas (cessation of breathing) and hypopneas (reduced airflow while breathing).
Diabetes Education: Diabetes Education will be delivered to participants in both the CPAP group and the Sham-CPAP group. The education will be based on ADA and AADE guidelines and consist of 2 in-person sessions (90 minutes and 60 minutes) and 3 follow-up phone calls 9about 15 minutes each)
|
Active CPAP Following Sham-CPAP
n=20 participants at risk
Persons who completed 12-weeks on sham-CPAP, were debriefed, titrated for active CPAP
|
|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Infection in knees bilateral
|
2.0%
1/49 • Number of events 1 • Until study completion, up to 36 weeks.
Any adverse event was evaluated at the scheduled participant assessments at 6 weeks, 12 weeks, 24 weeks, and 36 weeks.
|
0.00%
0/49 • Until study completion, up to 36 weeks.
Any adverse event was evaluated at the scheduled participant assessments at 6 weeks, 12 weeks, 24 weeks, and 36 weeks.
|
0.00%
0/20 • Until study completion, up to 36 weeks.
Any adverse event was evaluated at the scheduled participant assessments at 6 weeks, 12 weeks, 24 weeks, and 36 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Diagnosed with lymphoma
|
0.00%
0/49 • Until study completion, up to 36 weeks.
Any adverse event was evaluated at the scheduled participant assessments at 6 weeks, 12 weeks, 24 weeks, and 36 weeks.
|
2.0%
1/49 • Number of events 1 • Until study completion, up to 36 weeks.
Any adverse event was evaluated at the scheduled participant assessments at 6 weeks, 12 weeks, 24 weeks, and 36 weeks.
|
0.00%
0/20 • Until study completion, up to 36 weeks.
Any adverse event was evaluated at the scheduled participant assessments at 6 weeks, 12 weeks, 24 weeks, and 36 weeks.
|
|
Cardiac disorders
Hypertension
|
2.0%
1/49 • Number of events 1 • Until study completion, up to 36 weeks.
Any adverse event was evaluated at the scheduled participant assessments at 6 weeks, 12 weeks, 24 weeks, and 36 weeks.
|
0.00%
0/49 • Until study completion, up to 36 weeks.
Any adverse event was evaluated at the scheduled participant assessments at 6 weeks, 12 weeks, 24 weeks, and 36 weeks.
|
0.00%
0/20 • Until study completion, up to 36 weeks.
Any adverse event was evaluated at the scheduled participant assessments at 6 weeks, 12 weeks, 24 weeks, and 36 weeks.
|
Other adverse events
| Measure |
Active CPAP Treatment
n=49 participants at risk
Treatment of obstructive sleep apnea with continuous positive airway pressure (CPAP)
CPAP: CPAP is a device that has a mask worn over the nose that is attached to a device that provides positive airway pressure. CPAP is worn while sleeping, it splints open the airway and prevent apneas (cessation of breathing) and hypopneas (reduced airflow while breathing).
Diabetes Education: Diabetes Education will be delivered to participants in both the CPAP group and the Sham-CPAP group. The education will be based on ADA and AADE guidelines and consist of 2 in-person sessions (90 minutes and 60 minutes) and 3 follow-up phone calls 9about 15 minutes each)
|
Sham-CPAP
n=49 participants at risk
Device that appears like the treatment of obstructive sleep apnea, a continuous positive airway pressure device, but that does not provide treatment.
Sham-CPAP: Sham-CPAP is a device that has a mask worn over the nose that is attached to a device that looks and sounds like CPAP however it does not provide positive airway pressure. Sham-CPAP is worn while sleeping, it does not splint open the airway and prevent apneas (cessation of breathing) and hypopneas (reduced airflow while breathing).
Diabetes Education: Diabetes Education will be delivered to participants in both the CPAP group and the Sham-CPAP group. The education will be based on ADA and AADE guidelines and consist of 2 in-person sessions (90 minutes and 60 minutes) and 3 follow-up phone calls 9about 15 minutes each)
|
Active CPAP Following Sham-CPAP
n=20 participants at risk
Persons who completed 12-weeks on sham-CPAP, were debriefed, titrated for active CPAP
|
|---|---|---|---|
|
Product Issues
difficulty wearing mask
|
0.00%
0/49 • Until study completion, up to 36 weeks.
Any adverse event was evaluated at the scheduled participant assessments at 6 weeks, 12 weeks, 24 weeks, and 36 weeks.
|
4.1%
2/49 • Number of events 2 • Until study completion, up to 36 weeks.
Any adverse event was evaluated at the scheduled participant assessments at 6 weeks, 12 weeks, 24 weeks, and 36 weeks.
|
0.00%
0/20 • Until study completion, up to 36 weeks.
Any adverse event was evaluated at the scheduled participant assessments at 6 weeks, 12 weeks, 24 weeks, and 36 weeks.
|
Additional Information
Eileen R. Chasens, PhD, Professor of Nursing
University of Pittsburgh
Phone: 412-624-9380
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place