A Phase 2 interventional study of Continuous Positive Airway Pressure (CPAP) (Philips-Respironics RemStar Pro® CPAP) and Sham-Continuous Positive Airway Pressure (CPAP) (Philips-Respironics) in Impaired Glucose Tolerance and Obstructive Sleep Apnea, sponsored by Brigham and Women's Hospital. Completed. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2014-03-12.
Sponsored by Brigham and Women's Hospital · Phase 2, Interventional, and Treatment
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.
1,423 studies on the registry are indexed under Apnea; 160 are open to participants now.
This study's enrollment of 50 is close to the median of 51 across 966 interventional studies indexed under Apnea.
Browse Apnea studies →Brigham and Women's Hospital is the lead sponsor of 1,236 studies on the registry; 224 are open to participants now.
Of its 116 completed or terminated interventional studies of FDA-regulated products, 64 (55%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Device: Continuous Positive Airway Pressure (CPAP) (Philips-Respironics RemStar Pro® CPAP)
Device: Sham-Continuous Positive Airway Pressure (CPAP) (Philips-Respironics)
Subjects will be randomized to 8 weeks of CPAP or sham-CPAP, followed by the alternate therapy after a one month wash-out.
Also known as: Philips-Respironics RemStar Pro® CPAP
Subjects will be randomized to 8 weeks of CPAP or sham-CPAP, followed by the alternate therapy after a one month wash-out.
Also known as: Philips-Respironics Sham CPAP
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)
Time frame: 20 weeks
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)
Time frame: 20 weeks
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.
Time frame: 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
Time frame: 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.
Time frame: 20 Weeks
| Milestone | Continuous Positive Airway Pressure (CPAP) | Sham-Continuous Positive Airway Pressure |
|---|---|---|
| Started | 25 | 25 |
| Completed | 24 | 25 |
| Not completed | 1 | 0 |
| Withdrew: Physician decision | 1 | 0 |
| Milestone | Continuous Positive Airway Pressure (CPAP) | Sham-Continuous Positive Airway Pressure |
|---|---|---|
| Started | 24 | 25 |
| Completed | 24 | 25 |
| Not completed | 0 | 0 |
| Milestone | Continuous Positive Airway Pressure (CPAP) | Sham-Continuous Positive Airway Pressure |
|---|---|---|
| Started | 24 | 25 |
| Completed | 24 | 25 |
| Not completed | 0 | 0 |
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)
| subjects | Therapeutic CPAP | Sham CPAP |
|---|---|---|
| Number of Subjects With Normalization of Impaired Glucose Tolerance (IGT) | 7 | 5 |
Reported values include: fasting glucose (mg/dL), 2 hour Oral Glucose Tolerance Test (OGTT) (mg/dL)
| mg/dL | Therapeutic CPAP | Sham CPAP |
|---|---|---|
| Fasting Glucose (mg/dL), CPAP | 106.4 ± 12.4 | 105.6 ± 13.3 |
| 2-Hour OGTT (mg/dL), CPAP | 171.1 ± 43.5 | 178.2 ± 48.5 |
The data for fasting and 2 hour Insulin (iIU/dL) are presented according to therapeutic CPAP vs. Sham CPAP.
| iIU/dL | Therapeutic CPAP | Sham CPAP |
|---|---|---|
| Fasting Insulin (iIU/dL) | 16.4 ± 9.0 | 17.2 ± 10.1 |
| 2-Hour OGTT Insulin (iU/dL) | 110.1 ± 60.7 | 114.3 ± 68.1 |
Homeostasis Model Assessment-Insulin Resistance (HOMA-IR) with therapeutic CPAP vs. Sham CPAP
| percentage of beta cell function | Therapeutic CPAP | Sham CPAP |
|---|---|---|
| Mean and Standard Deviation of Indices of Insulin Resistance With Therapeutic CPAP vs. Sham | 4.4 ± 2.6 | 4.6 ± 3.0 |
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.
| units on a scale | Therapeutic CPAP | Sham CPAP |
|---|---|---|
| Mean and Standard Deviation of Insulin Sensitivity Index (ISI(0,120)) With Therapeutic CPAP vs. Sham | 12 ± 3.3 | 12 ± 3.8 |
Collected over 6 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Continuous Positive Airway Pressure (CPAP) | — | 1/50 (2%) | 12/50 (24%) |
| Sham-Continuous Positive Airway Pressure | — | 0/50 (0%) | 7/50 (14%) |
| Event | Continuous Positive Airway Pressure (CPAP) | Sham-Continuous Positive Airway Pressure |
|---|---|---|
| Chest Pain (non cardiac)Respiratory, thoracic and mediastinal disorders | 1/50 | 0/50 |
| Event | Continuous Positive Airway Pressure (CPAP) | Sham-Continuous Positive Airway Pressure |
|---|---|---|
| skin irritation from nasal CPAP maskSkin and subcutaneous tissue disorders | 6/50 | 2/50 |
| Nasal congestionRespiratory, thoracic and mediastinal disorders | 2/50 | 2/50 |
| Eye irritationEye disorders | 1/50 | 0/50 |
| Upper respiratory infectionRespiratory, thoracic and mediastinal disorders | 1/50 | 1/50 |
| Boil on LipNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/50 | 0/50 |
| Drowsy DrivingSocial circumstances | 0/50 | 1/50 |
| ClaustrophobiaPsychiatric disorders | 0/50 | 1/50 |
| Skin irritation from echocardiogram leadsSkin and subcutaneous tissue disorders | 1/50 | 0/50 |
| Ear PainEar and labyrinth disorders | 1/50 | 0/50 |
| Age, Categorical(Participants) | Continuous Positive Airway Pressure (CPAP) | Sham-Continuous Positive Airway Pressure | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 22 | 23 | 45 |
| >=65 years | 3 | 2 | 5 |
| Age, Continuous(years) | Continuous Positive Airway Pressure (CPAP) | Sham-Continuous Positive Airway Pressure | Total |
|---|---|---|---|
| Mean | 54 ± 10 | 53 ± 8 | 53.6 ± 9.9 |
| Sex: Female, Male(Participants) | Continuous Positive Airway Pressure (CPAP) | Sham-Continuous Positive Airway Pressure | Total |
|---|---|---|---|
| Female | 14 | 15 | 29 |
| Male | 11 | 10 | 21 |
| Region of Enrollment(participants) | Continuous Positive Airway Pressure (CPAP) | Sham-Continuous Positive Airway Pressure | Total |
|---|---|---|---|
| United States | 25 | 25 | 50 |
No study locations are listed for this record.
This study is completed, as verified in Feb 2014. You cannot join it, but the record below documents what was studied.
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