Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| UL1RR024989 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Center for Research Resources (NCRR) | NIH |
| Beth Israel Deaconess Medical Center | OTHER |
| Case Western Reserve University |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The investigators performed a randomized, cross-over controlled clinical trial comparing 8 weeks of Continuous Positive Airway Pressure (CPAP) to 8 weeks of sham-CPAP in patients with moderate to severe Sleep Disordered Breathing (SDB) and impaired glucose tolerance. A rigorous assessment of metabolic responses to SDB treatment in this group is of great clinical significance because this sample is at high risk for developing diabetes. The paradigm shift of CPAP as a mode of prevention can affect clinical practice in the fields of both primary care and sleep medicine.
There are few controlled studies that address whether treatment of sleep apnea improves glucose tolerance. This is a randomized, double-blind cross-over study of subjects with sleep apnea (apnea hypopnea index > 15) and impaired glucose tolerance. Subjects will be randomized to 8 weeks of Continuous Positive Airway Pressure (CPAP) or sham-CPAP, followed by the alternate therapy after a one month wash-out. After each treatment, subjects will undergo 2-hour oral glucose tolerance testing, polysomnography, actigraphy, and measurements of indices of glucose control. The investigators intend to analyze the changes in glucose metabolism and insulin sensitivity in patients with sleep apnea with CPAP intervention.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Continuous Positive Airway Pressure (CPAP) | Active Comparator |
| |
| Sham-Continuous Positive Airway Pressure (CPAP) | Sham Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Continuous Positive Airway Pressure (CPAP) (Philips-Respironics RemStar Pro® CPAP) | Device | Subjects will be randomized to 8 weeks of CPAP or sham-CPAP, followed by the alternate therapy after a one month wash-out. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With Normalization of Impaired Glucose Tolerance (IGT) | Number of subjects who experienced normalization of the mean 2-hour oral glucose tolerance test (OGTT) in the overall sample undergoing therapeutic CPAP vs. sham CPAP. (2-hour OGTT glucose< 140 mg/dL) | 20 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Mean and Standard Deviation of Glucose Indices After Therapeutic CPAP vs. Sham | Reported values include: fasting glucose (mg/dL), 2 hour Oral Glucose Tolerance Test (OGTT) (mg/dL) | 20 weeks |
| Mean and Standard Deviation of Insulin Indices After Therapeutic CPAP vs. Sham |
Not provided
Inclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Susan Redline, M.D., M.P.H. | Brigham and Women's Hospital | Study Director |
| Faramarz Beigi | Case Western Reserve University | Principal Investigator |
| H Lester Kirchner, PhD | Case Western Reserve University | Principal Investigator |
| Carol Rosen, M.D. | Case Western Reserve University | Principal Investigator |
| John Haaga, M.D. | Case Western Reserve University | Principal Investigator |
| Kingman Strohl, M.D. | Case Western Reserve University | Principal Investigator |
| Reena Mehra, M.S., M.S. | Case Western Reserve University | Principal Investigator |
| Denise Babineau, PhD | Case Western Reserve University | Principal Investigator |
| Tanya Weinstock, M.D. | Brigham and Women's Hospital | Principal Investigator |
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22547887 | Derived | Weinstock TG, Wang X, Rueschman M, Ismail-Beigi F, Aylor J, Babineau DC, Mehra R, Redline S. A controlled trial of CPAP therapy on metabolic control in individuals with impaired glucose tolerance and sleep apnea. Sleep. 2012 May 1;35(5):617-625B. doi: 10.5665/sleep.1816. |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Continuous Positive Airway Pressure (CPAP) | |
| FG001 | Sham-Continuous Positive Airway Pressure |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1, 2 Months |
|
| ||||||||||||||||||
| Washout Period, 1 Month |
| |||||||||||||||||||
| Period 2, 2 Months |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Continuous Positive Airway Pressure (CPAP) | |
| BG001 | Sham-Continuous Positive Airway Pressure | |
| BG002 | Total |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Subjects With Normalization of Impaired Glucose Tolerance (IGT) | Number of subjects who experienced normalization of the mean 2-hour oral glucose tolerance test (OGTT) in the overall sample undergoing therapeutic CPAP vs. sham CPAP. (2-hour OGTT glucose< 140 mg/dL) | All available oral glucose tolerance test data was analyzed for the total sample. | Posted | Number | subjects | 20 weeks |
|
6 months
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Continuous Positive Airway Pressure (CPAP) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chest Pain (non cardiac) | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| skin irritation from nasal CPAP mask | Skin and subcutaneous tissue disorders | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Susan Redline | Brigham and Women's Hospital | 857-307-0352 | sredline1@rics.bwh.harvard.edu |
Not provided
| ID | Term |
|---|---|
| D018149 | Glucose Intolerance |
| D020181 | Sleep Apnea, Obstructive |
| ID | Term |
|---|---|
| D006943 | Hyperglycemia |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D045422 | Continuous Positive Airway Pressure |
| ID | Term |
|---|---|
| D011175 | Positive-Pressure Respiration |
| D012121 | Respiration, Artificial |
| D058109 | Airway Management |
| D013812 | Therapeutics |
Not provided
Not provided
| OTHER |
Not provided
Not provided
Not provided
Not provided
|
| Sham-Continuous Positive Airway Pressure (CPAP) (Philips-Respironics) | Device | Subjects will be randomized to 8 weeks of CPAP or sham-CPAP, followed by the alternate therapy after a one month wash-out. |
|
|
The data for fasting and 2 hour Insulin (iIU/dL) are presented according to therapeutic CPAP vs. Sham CPAP. |
| 20 weeks |
| Mean and Standard Deviation of Indices of Insulin Resistance With Therapeutic CPAP vs. Sham | Homeostasis Model Assessment-Insulin Resistance (HOMA-IR) with therapeutic CPAP vs. Sham CPAP | 20 weeks |
| Mean and Standard Deviation of Insulin Sensitivity Index (ISI(0,120)) With Therapeutic CPAP vs. Sham | Insulin Sensitivity Index derived from the Gutt Index, uses the plasma glucose and insulin concentration from fasting (0 min) and 120-min samples from the OGTT, to calculate (Metabolic Clearance Rate)/log (Mean Serum Insulin). The range of possible values is based on the subset ranges of fasting and oral glucose tolerance test (OGTT) insulin and fasting and OGTT glucose, which calculate to be a range of 1.6 to 206.8. An increase in the ISI (0,120) indicates an improvement in the insulin sensitivity. | 20 Weeks |
| NOT COMPLETED |
|
| NOT COMPLETED |
|
Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Assessment of number of subjects with normalization of oral glucose tolerance test from baseline after sham CPAP therapy, in total sample, with the sham periods of both sequences combined.
|
|
|
| Secondary | Mean and Standard Deviation of Glucose Indices After Therapeutic CPAP vs. Sham | Reported values include: fasting glucose (mg/dL), 2 hour Oral Glucose Tolerance Test (OGTT) (mg/dL) | Posted | Mean | Standard Deviation | mg/dL | 20 weeks |
|
|
|
|
| Secondary | Mean and Standard Deviation of Insulin Indices After Therapeutic CPAP vs. Sham | The data for fasting and 2 hour Insulin (iIU/dL) are presented according to therapeutic CPAP vs. Sham CPAP. | All subjects with available fasting and and 2-hour insulin measurements are included. | Posted | Mean | Standard Deviation | iIU/dL | 20 weeks |
|
|
|
|
| Secondary | Mean and Standard Deviation of Indices of Insulin Resistance With Therapeutic CPAP vs. Sham | Homeostasis Model Assessment-Insulin Resistance (HOMA-IR) with therapeutic CPAP vs. Sham CPAP | All subjects with available fasting insulin, glucose measurements | Posted | Mean | Standard Deviation | percentage of beta cell function | 20 weeks |
|
|
|
|
| Secondary | Mean and Standard Deviation of Insulin Sensitivity Index (ISI(0,120)) With Therapeutic CPAP vs. Sham | Insulin Sensitivity Index derived from the Gutt Index, uses the plasma glucose and insulin concentration from fasting (0 min) and 120-min samples from the OGTT, to calculate (Metabolic Clearance Rate)/log (Mean Serum Insulin). The range of possible values is based on the subset ranges of fasting and oral glucose tolerance test (OGTT) insulin and fasting and OGTT glucose, which calculate to be a range of 1.6 to 206.8. An increase in the ISI (0,120) indicates an improvement in the insulin sensitivity. | Posted | Mean | Standard Deviation | units on a scale | 20 Weeks |
|
|
|
|
| 1 |
| 50 |
| 12 |
| 50 |
| EG001 | Sham-Continuous Positive Airway Pressure | 0 | 50 | 7 | 50 |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Eye irritation | Eye disorders | Systematic Assessment |
|
| Upper respiratory infection | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Boil on Lip | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| Drowsy Driving | Social circumstances | Systematic Assessment | Deemed to be unrelated to study; direct result from sleep deprivation; event last less than 5 seconds. |
|
| Claustrophobia | Psychiatric disorders | Systematic Assessment | secondary to mask |
|
| Skin irritation from echocardiogram leads | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Ear Pain | Ear and labyrinth disorders | Systematic Assessment | While wearing mask |
|
Not provided
Not provided
Not provided
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D012138 |
| Respiratory Therapy |
| Based on an intent-to-treat approach, a linear mixed effect model was used to estimate the association between measures of glucose indices, in this case, 2 hour OGTT, and therapeutic CPAP vs. Sham. | Regression, Linear | Adjusted for period, baseline level of the outcome variable, BMI, AHI, gender and race. | 0.11 | Mean Difference (Final Values) | -7.3 | 2-Sided | 95 | -16.3 | 1.7 | No | Superiority or Other |
| Based on an intent-to-treat approach, a linear mixed effect model was used to estimate the association between therapy and measures of glucose indices, in this case fasting glucose, between CPAP and sham-CPAP, stratified for the most severe sleep apnea group (Apnea-Hypopnea Index (AHI) >=30) in order to assess whether the differences in the effect of CPAP on outcomes were observed according to sleep apnea severity. N=25. | Regression, Linear | 0.86 | Mean Difference (Final Values) | -0.3 | 2-Sided | 95 | -3.3 | 2.7 | No | Superiority or Other |
| Based on an intent-to-treat approach, a linear mixed effect model was used to estimate the association between therapy and measures of glucose indices, in this case 2-hour oral glucose tolerance test (OGTT) glucose, between CPAP and sham-CPAP, stratified for the most severe sleep apnea group (Apnea-Hypopnea Index (AHI) >=30) in order to assess whether the differences in the effect of CPAP on outcomes were observed according to sleep apnea severity. N= 25. | Regression, Linear | Adjusted for period, baseline level of the outcome variable, BMI, AHI, gender and race. | 0.08 | Mean Difference (Final Values) | -11.6 | 2-Sided | 95 | -24.6 | 1.3 | No | Superiority or Other |
| Based on an intent-to-treat approach, a linear mixed effect model was used to estimate the association between therapy and measures of insulin indices, in this case, 2-hour oral glucose tolerance test (OGTT) insulin, between CPAP and sham-CPAP. | Regression, Linear | Adjusted for period, baseline level of the outcome variable, BMI, Apnea-Hypopnea Index (AHI), gender and race. | 0.12 | Mean Difference (Final Values) | -10.7 | 2-Sided | 95 | -23.3 | 2.8 | No | Superiority or Other |
| Based on an intent-to-treat approach, a linear mixed effect model was used to estimate the association between therapy and measures of insulin indices, in this case fasting insulin, between CPAP and sham-CPAP, stratified for the most severe sleep apnea group (Apnea-Hypopnea Index (AHI) >=30) in order to assess whether the differences in the effect of CPAP on outcomes were observed according to sleep apnea severity. N=23. | Regression, Linear | Adjusted for period, baseline level of the outcome variable, BMI, AHI, gender and race. | 0.10 | Mean Difference (Final Values) | -2.4 | 2-Sided | 95 | -5.2 | 0.5 | No | Superiority or Other |
| Based on an intent-to-treat approach, a linear mixed effect model was used to estimate the association between therapy and measures of insulin indices, in this case oral glucose tolerance test (OGTT) insulin, between CPAP and sham-CPAP, stratified for the most severe sleep apnea group (Apnea-Hypopnea Index (AHI) >=30) in order to assess whether the differences in the effect of CPAP on outcomes were observed according to sleep apnea severity. N=23. | Regression, Linear | Adjusted for period, baseline level of the outcome variable, BMI, AHI, gender and race. | 0.002 | Mean Difference (Final Values) | -28.7 | 2-Sided | 95 | -46.5 | -10.9 | No | Superiority or Other |
Based on an intent-to-treat approach, a linear mixed effect model was used to estimate the association between therapy and measures of insulin resistance, in this case Homeostasis Model Assessment-Insulin Resistance (HOMA-IR), between CPAP and sham-CPAP, stratified for the most severe sleep apnea group (Apnea-Hypopnea Index (AHI) >=30) in order to assess whether the differences in the effect of CPAP on outcomes were observed according to sleep apnea severity. N=23. |
| Regression, Linear |
Adjusted for period, baseline level of the outcome variable, BMI, AHI, gender and race. |
| 0.08 |
| Mean Difference (Final Values) |
| -14.1 |
| 2-Sided |
| 95 |
| -27.5 |
| 1.8 |
| No |
| Superiority or Other |
|
Based on an intent-to-treat approach, a linear mixed effect model was used to estimate the association between therapy and the Insulin Sensitivity Index (ISI(0,120)), between CPAP and sham-CPAP, stratified for the most severe sleep apnea group (Apnea-Hypopnea Index (AHI) >=30) in order to assess whether the differences in the effect of CPAP on outcomes were observed according to sleep apnea severity. N=23. |
| Regression, Linear |
Adjusted for period, baseline level of the outcome variable, BMI, AHI, gender and race. |
| 0.002 |
| Mean Difference (Final Values) |
| 13.3 |
| 2-Sided |
| 95 |
| 5.2 |
| 22.1 |
| No |
| Superiority or Other |