Type 2 Diabetes, Obstructive Sleep Apnea
Conditions
Keywords
sleep apnea, diabetes
Brief summary
Diabetes self-management is important to help adults with type 2 diabetes achieve glucose control. Obstructive sleep apnea often co-exists with type 2 diabetes and may act as a barrier to diabetes self-management and glucose control. We will examine if treatment of obstructive sleep apnea with continuous positive airway pressure (CPAP), combined with diabetes education, results in improved diabetes self-management and glucose control.
Detailed description
While diabetes self-management has been improved and refined over the last 30 years, many persons with T2DM continue to have difficulty in achieving glycemic goals. Obstructive sleep apnea (OSA) has a high prevalence among adults with type 2 diabetes (T2DM) and is associated with excessive daytime sleepiness, impaired mood, decreased vigilance, and reduced functional outcomes. The degree that OSA affects diabetes self-management, a known determinant of glycemic control, remains unstudied. The most effective treatment for OSA, continuous positive airway pressure (CPAP), results in improved self-reported daytime functioning. However, the effect of CPAP treatment on reception of diabetes education remains unknown. The underlying premise of the proposed study from this new investigator is that OSA hinders diabetes self-management in adults with T2DM. Our goal is to improve understanding of the effect of OSA on diabetes self-management and to determine the efficacy of CPAP treatment in improving diabetes outcomes in adults treated with CPAP compared to those on sham-CPAP. Expanding our understanding of the effect of sleep disturbances on diabetes self-management may lead to improved guidelines for screening and treatment of OSA in the increasingly large portion of the population with diabetes
Interventions
DEVICECPAP
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).
DEVICESham-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).
BEHAVIORALDiabetes 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)
Sponsors
Eileen R. Chasens
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Intervention model description
Parallel was a one-way cross over after 12 weeks with persons originally in the sham group being titrated onto active CPAP.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Suboptimal glucose control (A1C ≥ 6.5%) * Moderate-to-severe obstructive sleep apnea (apnea + hypopnea index \>= 10/hour) * age 18 years and older
Exclusion criteria
* Poor glucose control (A1C \> 11) * Type 1 or gestational diabetes * Sleep duration \< 4 hrs * Acute medical or surgical conditions or hospitalization ≤ 3 months * Oxygen or bi-level PAP required * Prior CPAP or persons in household with CPAP * Employed in safety sensitive job * Pregnant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HbA1C Level | baseline, 6 weeks, 12 weeks | Glycated hemoglobin test that estimates the blood glucose level over last 2 to 3 months. Higher scores indicate worse diabetes control. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Diabetes Diet Adherence | baseline, 6 weeks, 12 weeks | 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 |
| Diabetes Knowledge | baseline,12 weeks only | 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) |
| Self-Monitoring of Blood Glucose (SMBG) | baseline, 6 weeks, 12 weeks | 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 |
| Steps Walked | baseline, 6 weeks, 12 weeks | 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. |
| Fructosamine Level | baseline, 6 weeks, 12 weeks | 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. |
| Diabetes-Related Distress | baseline, 6 weeks, 12 weeks | Score of the Problem Areas in Diabetes (PAID) Questionnaire; scores range from 0-100, higher scores indicate worse diabetes-related distress. |
| Sleep Quality | baseline, 6 weeks, 12 weeks | 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. |
| Mood | baseline, 6 weeks, 12 weeks | Mood impairment measured by the Profile of Mood States (POMS) total score; potential scores range from 0 to 60; higher scores indicate worse mood. |
| Vigilance | 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 session | 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. |
| Self-Monitoring of Foot Care | baseline, 6 weeks, 12 weeks | 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 |
Countries
United States
Participant flow
Recruitment details
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).
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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) | 49 |
| 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) | 49 |
| Total | 98 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| 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 | 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 | Physician Decision | 2 | 1 |
| 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 | Physician Decision | 1 | 0 |
| Week 24 | Withdrawal by Subject | 13 | 19 |
| Week 36 | Withdrawal by Subject | 0 | 5 |
Baseline characteristics
| Characteristic | Active CPAP Treatment | Sham-CPAP | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 18 Participants | 11 Participants | 29 Participants |
| Age, Categorical Between 18 and 65 years | 31 Participants | 38 Participants | 69 Participants |
| Age, Continuous | 60.08 years STANDARD_DEVIATION 10.13 | 57.37 years STANDARD_DEVIATION 9.32 | 58.72 years STANDARD_DEVIATION 9.78 |
| Apnea-Hypopnea Index | 22.48 events per hour of sleep STANDARD_DEVIATION 13.41 | 25.92 events per hour of sleep STANDARD_DEVIATION 15.86 | 24.20 events per hour of sleep STANDARD_DEVIATION 14.71 |
| Body Mass Index (kg/m^2) | 35.71 kg/m^2 STANDARD_DEVIATION 6.16 | 36.69 kg/m^2 STANDARD_DEVIATION 6.99 | 36.20 kg/m^2 STANDARD_DEVIATION 6.57 |
| Epworth Sleepiness Scale | 10.22 units on a scale STANDARD_DEVIATION 4.36 | 10.39 units on a scale STANDARD_DEVIATION 4.76 | 10.31 units on a scale STANDARD_DEVIATION 4.54 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 1 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 48 Participants | 48 Participants | 96 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Fructosamine | 285.10 µmol/L STANDARD_DEVIATION 45.2 | 301.88 µmol/L STANDARD_DEVIATION 54.41 | 293.59 µmol/L STANDARD_DEVIATION 50.48 |
| HbA1c | 7.73 percentage of glycated hemoglobins STANDARD_DEVIATION 0.75 | 8.04 percentage of glycated hemoglobins STANDARD_DEVIATION 1.01 | 7.89 percentage of glycated hemoglobins STANDARD_DEVIATION 0.9 |
| Pittsburgh Sleep Quality Index Total Score | 10.00 units on a scale STANDARD_DEVIATION 3.61 | 9.67 units on a scale STANDARD_DEVIATION 4.19 | 9.84 units on a scale STANDARD_DEVIATION 3.89 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 13 Participants | 8 Participants | 21 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 3 Participants | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 36 Participants | 37 Participants | 73 Participants |
| Region of Enrollment United States | 49 participants | 49 participants | 98 participants |
| Sex: Female, Male Female | 23 Participants | 19 Participants | 42 Participants |
| Sex: Female, Male Male | 26 Participants | 30 Participants | 56 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 49 | 0 / 49 | 0 / 20 |
| other Total, other adverse events | 0 / 49 | 2 / 49 | 0 / 20 |
| serious Total, serious adverse events | 1 / 49 | 1 / 49 | 0 / 20 |
Outcome results
Primary
HbA1C Level
Glycated hemoglobin test that estimates the blood glucose level over last 2 to 3 months. Higher scores indicate worse diabetes control.
Time frame: baseline, 6 weeks, 12 weeks
Population: All randomized participants were analyzed (the intention to treat method).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Active CPAP Treatment | HbA1C Level | Baseline | 7.73 % of glycated hemoglobin in the blood | Standard Error 0.13 |
| Active CPAP Treatment | HbA1C Level | 6-week | 7.49 % of glycated hemoglobin in the blood | Standard Error 0.17 |
| Active CPAP Treatment | HbA1C Level | 12-week | 7.46 % of glycated hemoglobin in the blood | Standard Error 0.15 |
| Sham-CPAP Treatment | HbA1C Level | Baseline | 8.04 % of glycated hemoglobin in the blood | Standard Error 0.13 |
| Sham-CPAP Treatment | HbA1C Level | 6-week | 820 % of glycated hemoglobin in the blood | Standard Error 0.17 |
| Sham-CPAP Treatment | HbA1C Level | 12-week | 7.80 % of glycated hemoglobin in the blood | Standard Error 0.16 |
Comparison: Statistical analyses were revised from the original protocol for reporting results at 24 week because unable to recruit an adequate sample size at this time point of participants originally on CPAP for 24 weeks and those who were in the original sham-CPAP group who crossed over to CPAP and completed 24 weeks of treatment.p-value: 0.01795% CI: [-0.68, 0.04]Mixed Models Analysis
Secondary
Diabetes Diet Adherence
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
Time frame: baseline, 6 weeks, 12 weeks
Population: All randomized participants with valid data were analyzed (the intention to treat method). One participant with missing data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Active CPAP Treatment | Diabetes Diet Adherence | 12-week | 4.30 Average number of days/week | Standard Error 0.25 |
| Active CPAP Treatment | Diabetes Diet Adherence | 6-week | 4.18 Average number of days/week | Standard Error 0.27 |
| Active CPAP Treatment | Diabetes Diet Adherence | Baseline | 3.55 Average number of days/week | Standard Error 0.29 |
| Sham-CPAP Treatment | Diabetes Diet Adherence | 12-week | 4.05 Average number of days/week | Standard Error 0.27 |
| Sham-CPAP Treatment | Diabetes Diet Adherence | Baseline | 3.61 Average number of days/week | Standard Error 0.3 |
| Sham-CPAP Treatment | Diabetes Diet Adherence | 6-week | 4.05 Average number of days/week | Standard Error 0.29 |
p-value: 0.73295% CI: [-0.85, 0.35]Mixed Models Analysis
Secondary
Diabetes Knowledge
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)
Time frame: baseline,12 weeks only
Population: All randomized participants were analyzed (the intention to treat method).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Active CPAP Treatment | Diabetes Knowledge | Baseline | 79.39 % of correct answers | Standard Error 1.88 |
| Active CPAP Treatment | Diabetes Knowledge | 12-week | 83.20 % of correct answers | Standard Error 1.79 |
| Sham-CPAP Treatment | Diabetes Knowledge | Baseline | 75.74 % of correct answers | Standard Error 1.88 |
| Sham-CPAP Treatment | Diabetes Knowledge | 12-week | 79.81 % of correct answers | Standard Error 1.88 |
p-value: 0.91995% CI: [-1.62, 8.92]Mixed Models Analysis
Secondary
Diabetes-Related Distress
Score of the Problem Areas in Diabetes (PAID) Questionnaire; scores range from 0-100, higher scores indicate worse diabetes-related distress.
Time frame: baseline, 6 weeks, 12 weeks
Population: All randomized participants were analyzed (the intention to treat method).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Active CPAP Treatment | Diabetes-Related Distress | Baseline | 29.18 score on a scale | Standard Error 2.77 |
| Active CPAP Treatment | Diabetes-Related Distress | 6-week | 22.75 score on a scale | Standard Error 2.72 |
| Active CPAP Treatment | Diabetes-Related Distress | 12-week | 20.7413 score on a scale | Standard Error 2.6 |
| Sham-CPAP Treatment | Diabetes-Related Distress | 12-week | 19.99 score on a scale | Standard Error 2.76 |
| Sham-CPAP Treatment | Diabetes-Related Distress | Baseline | 26.44 score on a scale | Standard Error 2.79 |
| Sham-CPAP Treatment | Diabetes-Related Distress | 6-week | 20.08 score on a scale | Standard Error 2.81 |
p-value: 0.77695% CI: [-4.78, 10.86]Mixed Models Analysis
Secondary
Fructosamine Level
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.
Time frame: baseline, 6 weeks, 12 weeks
Population: 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)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Active CPAP Treatment | Fructosamine Level | Baseline | 285.94 umol/L (micromols per liter) | Standard Error 7.78 |
| Active CPAP Treatment | Fructosamine Level | 6-week | 272.84 umol/L (micromols per liter) | Standard Error 7.32 |
| Active CPAP Treatment | Fructosamine Level | 12-week | 274.87 umol/L (micromols per liter) | Standard Error 7.53 |
| Sham-CPAP Treatment | Fructosamine Level | 12-week | 285.56 umol/L (micromols per liter) | Standard Error 7.8 |
| Sham-CPAP Treatment | Fructosamine Level | Baseline | 300.99 umol/L (micromols per liter) | Standard Error 7.68 |
| Sham-CPAP Treatment | Fructosamine Level | 6-week | 293.73 umol/L (micromols per liter) | Standard Error 7.53 |
p-value: 0.30795% CI: [-38.66, 5.09]Mixed Models Analysis
Secondary
Mood
Mood impairment measured by the Profile of Mood States (POMS) total score; potential scores range from 0 to 60; higher scores indicate worse mood.
Time frame: baseline, 6 weeks, 12 weeks
Population: All randomized participants were analyzed (the intention to treat method).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Active CPAP Treatment | Mood | Baseline | 28.94 score on a scale | Standard Error 5.12 |
| Active CPAP Treatment | Mood | 6-week | 17.28 score on a scale | Standard Error 5.35 |
| Active CPAP Treatment | Mood | 12-week | 19.32 score on a scale | Standard Error 5.85 |
| Sham-CPAP Treatment | Mood | Baseline | 25.76 score on a scale | Standard Error 5.12 |
| Sham-CPAP Treatment | Mood | 6-week | 23.17 score on a scale | Standard Error 5.49 |
| Sham-CPAP Treatment | Mood | 12-week | 22.61 score on a scale | Standard Error 6.1 |
p-value: 0.21395% CI: [-11.19, 17.56]Mixed Models Analysis
Secondary
Self-Monitoring of Blood Glucose (SMBG)
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
Time frame: baseline, 6 weeks, 12 weeks
Population: All randomized participants were analyzed (the intention to treat method).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Active CPAP Treatment | Self-Monitoring of Blood Glucose (SMBG) | Baseline | 4.17 Average number of days/week | Standard Error 0.38 |
| Active CPAP Treatment | Self-Monitoring of Blood Glucose (SMBG) | 6-week | 5.44 Average number of days/week | Standard Error 0.31 |
| Active CPAP Treatment | Self-Monitoring of Blood Glucose (SMBG) | 12-week | 5.52 Average number of days/week | Standard Error 0.34 |
| Sham-CPAP Treatment | Self-Monitoring of Blood Glucose (SMBG) | Baseline | 4.24 Average number of days/week | Standard Error 0.38 |
| Sham-CPAP Treatment | Self-Monitoring of Blood Glucose (SMBG) | 6-week | 5.10 Average number of days/week | Standard Error 0.33 |
| Sham-CPAP Treatment | Self-Monitoring of Blood Glucose (SMBG) | 12-week | 4.61 Average number of days/week | Standard Error 0.36 |
p-value: 0.12595% CI: [-1.18, 0.96]Mixed Models Analysis
Secondary
Self-Monitoring of Foot Care
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
Time frame: baseline, 6 weeks, 12 weeks
Population: All randomized participants were analyzed (the intention to treat method).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Active CPAP Treatment | Self-Monitoring of Foot Care | Baseline | 3.26 Average number of days/week | Standard Error 0.35 |
| Active CPAP Treatment | Self-Monitoring of Foot Care | 6-week | 3.56 Average number of days/week | Standard Error 0.37 |
| Active CPAP Treatment | Self-Monitoring of Foot Care | 12-week | 4.18 Average number of days/week | Standard Error 0.37 |
| Sham-CPAP Treatment | Self-Monitoring of Foot Care | Baseline | 3.89 Average number of days/week | Standard Error 0.35 |
| Sham-CPAP Treatment | Self-Monitoring of Foot Care | 6-week | 4.44 Average number of days/week | Standard Error 0.39 |
| Sham-CPAP Treatment | Self-Monitoring of Foot Care | 12-week | 4.57 Average number of days/week | Standard Error 0.39 |
p-value: 0.46195% CI: [-1.61, 0.35]Mixed Models Analysis
Secondary
Sleep Quality
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.
Time frame: baseline, 6 weeks, 12 weeks
Population: All randomized participants were analyzed (the intention to treat method).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Active CPAP Treatment | Sleep Quality | Baseline | 10.00 score on a scale | Standard Error 0.56 |
| Active CPAP Treatment | Sleep Quality | 6-week | 8.12 score on a scale | Standard Error 0.52 |
| Active CPAP Treatment | Sleep Quality | 12-week | 8.77 score on a scale | Standard Error 0.55 |
| Sham-CPAP Treatment | Sleep Quality | Baseline | 9.67 score on a scale | Standard Error 0.56 |
| Sham-CPAP Treatment | Sleep Quality | 6-week | 8.57 score on a scale | Standard Error 0.54 |
| Sham-CPAP Treatment | Sleep Quality | 12-week | 8.54 score on a scale | Standard Error 0.59 |
p-value: 0.37895% CI: [-1.24, 1.89]Mixed Models Analysis
Secondary
Steps Walked
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.
Time frame: baseline, 6 weeks, 12 weeks
Population: All randomized participants were analyzed (the intention to treat method).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Active CPAP Treatment | Steps Walked | Baseline | 4550.83 Steps/day | Standard Error 374.15 |
| Active CPAP Treatment | Steps Walked | 6-week | 4774.81 Steps/day | Standard Error 386.56 |
| Active CPAP Treatment | Steps Walked | 12-week | 4741.43 Steps/day | Standard Error 355.27 |
| Sham-CPAP Treatment | Steps Walked | Baseline | 4463.61 Steps/day | Standard Error 374.15 |
| Sham-CPAP Treatment | Steps Walked | 6-week | 4240.42 Steps/day | Standard Error 403.84 |
| Sham-CPAP Treatment | Steps Walked | 12-week | 4403.97 Steps/day | Standard Error 372.96 |
p-value: 0.63995% CI: [-936.1, 1137.5]Mixed Models Analysis
Secondary
Vigilance
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.
Time frame: 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 session
Population: 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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Active CPAP Treatment | Vigilance | Baseline | 4.68 transformed lapses | Standard Error 0.45 |
| Active CPAP Treatment | Vigilance | Average Lapses First Diabetes Session | 4.30 transformed lapses | Standard Error 0.47 |
| Active CPAP Treatment | Vigilance | Average lapses 2nd Diabetes Education Session | 3.59 transformed lapses | Standard Error 0.54 |
| Sham-CPAP Treatment | Vigilance | Baseline | 4.67 transformed lapses | Standard Error 0.45 |
| Sham-CPAP Treatment | Vigilance | Average Lapses First Diabetes Session | 3.56 transformed lapses | Standard Error 0.47 |
| Sham-CPAP Treatment | Vigilance | Average lapses 2nd Diabetes Education Session | 4.78 transformed lapses | Standard Error 0.54 |
p-value: 0.00595% CI: [-1.27, 1.28]Mixed Models Analysis