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Effects of Continuous Positive Airway Pressure (CPAP) on Glucose Metabolism (SOMNOS)

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ClinicalTrials.gov Identifier: NCT01503164
Recruitment Status : Completed
First Posted : January 2, 2012
Results First Posted : October 19, 2017
Last Update Posted : October 19, 2017
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Johns Hopkins University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Obstructive Sleep Apnea
Sleep Apnea
Sleep-disordered Breathing
Interventions Device: Positive Pressure Therapy (PAP)
Behavioral: LifeStyle Counseling
Enrollment 111

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Positive Pressure Therapy (PAP) Lifestyle Counseling
Hide Arm/Group Description

Positive airway pressure(PAP) therapy is the standard of care for patients with obstructive sleep apnea. During sleep, a mask is worn over the nose and connected to the PAP machine.

Positive Pressure Therapy (PAP): Positive pressure therapy is the standard of care for managing obstructive sleep apnea. It entails wearing a mask that is connected to the PAP device which deliver pressure to the upper airway during sleep.

LifeStyle Counseling: Subjects randomized to the lifestyle (and nutritional) counseling arm will be given advice on a balanced dietary and exercise plan.
Period Title: Overall Study
Started 55 56
Completed 53 55
Not Completed 2 1
Reason Not Completed
Withdrawal by Subject             2             1
Arm/Group Title Positive Pressure Therapy (PAP) Lifestyle Counseling Total
Hide Arm/Group Description

Positive airway pressure(PAP) therapy is the standard of care for patients with obstructive sleep apnea. During sleep, a mask is worn over the nose and connected to the PAP machine.

Positive Pressure Therapy (PAP): Positive pressure therapy is the standard of care for managing obstructive sleep apnea. It entails wearing a mask that is connected to the PAP device which deliver pressure to the upper airway during sleep.

Positive Pressure Therapy (PAP): Positive pressure therapy is the standard of care for managing obstructive sleep apnea. It entails wearing a mask that is connected to the PAP device which deliver pressure to the upper airway during sleep.

LifeStyle Counseling: Subjects randomized to the lifestyle (and nutritional) counseling arm will be given advice on a balanced dietary and exercise plan.

Total of all reporting groups
Overall Number of Baseline Participants 53 55 108
Hide Baseline Analysis Population Description
55 randomized to PAP (2 dropout); 56 randomized to lifestyle (1 dropout)
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 53 participants 55 participants 108 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
45
  84.9%
44
  80.0%
89
  82.4%
>=65 years
8
  15.1%
11
  20.0%
19
  17.6%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 53 participants 55 participants 108 participants
54.8  (9.2) 57.2  (8.2) 56.0  (8.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 53 participants 55 participants 108 participants
Female
12
  22.6%
16
  29.1%
28
  25.9%
Male
41
  77.4%
39
  70.9%
80
  74.1%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 53 participants 55 participants 108 participants
53
 100.0%
55
 100.0%
108
 100.0%
1.Primary Outcome
Title Insulin Sensitivity (SI)
Hide Description Insulin sensitivity will be determined with the insulin-modified frequently sampled intravenous glucose tolerance test (IVGTT) before and 2-months after study intervention. This test requires administration of a weight-adjusted dose of D50W as an IV bolus at time "zero". After the glucose bolus, blood samples are drawn at the scheduled times for 3-hours. At the 20-minute mark, a weight-adjusted dose of regular insulin is administered. The resulting serum is analyzed for glucose and insulin and the "minimal model" (MINMOD) will be used to derive insulin sensitivity. A low SI signifies low insulin sensitivity and high SI represents high insulin sensitivity.
Time Frame Baseline
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
55 randomized to PAP (2 dropout); 56 randomized to lifestyle (1 dropout)
Arm/Group Title Positive Pressure Therapy (PAP) Lifestyle Counseling
Hide Arm/Group Description:

Positive airway pressure(PAP) therapy is the standard of care for patients with obstructive sleep apnea. During sleep, a mask is worn over the nose and connected to the PAP machine.

Positive Pressure Therapy (PAP): Positive pressure therapy is the standard of care for managing obstructive sleep apnea. It entails wearing a mask that is connected to the PAP device which deliver pressure to the upper airway during sleep.

Positive Pressure Therapy (PAP): Positive pressure therapy is the standard of care for managing obstructive sleep apnea. It entails wearing a mask that is connected to the PAP device which deliver pressure to the upper airway during sleep.

LifeStyle Counseling: Subjects randomized to the lifestyle (and nutritional) counseling arm will be given advice on a balanced dietary and exercise plan.

Overall Number of Participants Analyzed 53 55
Mean (Standard Deviation)
Unit of Measure: [mU/L]^-1 x [min]^-1
1.95  (1.21) 2.22  (1.45)
2.Primary Outcome
Title Insulin Sensitivity (SI)
Hide Description Insulin sensitivity will be determined with the insulin-modified frequently sampled intravenous glucose tolerance test (IVGTT) before and 2-months after study intervention. This test requires administration of a weight-adjusted dose of D50W as an IV bolus at time "zero". After the glucose bolus, blood samples are drawn at the scheduled times for 3-hours. At the 20-minute mark, a weight-adjusted dose of regular insulin is administered. The resulting serum is analyzed for glucose and insulin and the "minimal model" (MINMOD) will be used to derive insulin sensitivity. A low SI signifies low insulin sensitivity and high SI represents high insulin sensitivity.
Time Frame 2 months after intervention
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
55 randomized to PAP (2 dropout); 56 randomized to lifestyle (1 dropout)
Arm/Group Title Positive Pressure Therapy (PAP) Lifestyle Counseling
Hide Arm/Group Description:

Positive airway pressure(PAP) therapy is the standard of care for patients with obstructive sleep apnea. During sleep, a mask is worn over the nose and connected to the PAP machine.

Positive Pressure Therapy (PAP): Positive pressure therapy is the standard of care for managing obstructive sleep apnea. It entails wearing a mask that is connected to the PAP device which deliver pressure to the upper airway during sleep.

Positive Pressure Therapy (PAP): Positive pressure therapy is the standard of care for managing obstructive sleep apnea. It entails wearing a mask that is connected to the PAP device which deliver pressure to the upper airway during sleep.

LifeStyle Counseling: Subjects randomized to the lifestyle (and nutritional) counseling arm will be given advice on a balanced dietary and exercise plan.

Overall Number of Participants Analyzed 53 55
Mean (Standard Deviation)
Unit of Measure: [mU/L]^-1 x [min]^-1
3.01  (2.77) 1.83  (1.03)
3.Secondary Outcome
Title Glucose Effectiveness (SG)
Hide Description Glucose effectiveness is the ability for glucose to move intracellularly in the absence of insulin. It is a parameter that results from the MINMOD analysis of the serum glucose and insulin levels derived from the frequently sampled intravenous glucose tolerance test. Low SG indicates a lower predisposition for glucose disposal independent of any effects of insulin.
Time Frame Baseline
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
55 randomized to PAP (2 dropout); 56 randomized to lifestyle (1 dropout)
Arm/Group Title Positive Pressure Therapy (PAP) Lifestyle Counseling
Hide Arm/Group Description:

Positive airway pressure(PAP) therapy is the standard of care for patients with obstructive sleep apnea. During sleep, a mask is worn over the nose and connected to the PAP machine.

Positive Pressure Therapy (PAP): Positive pressure therapy is the standard of care for managing obstructive sleep apnea. It entails wearing a mask that is connected to the PAP device which deliver pressure to the upper airway during sleep.

Positive Pressure Therapy (PAP): Positive pressure therapy is the standard of care for managing obstructive sleep apnea. It entails wearing a mask that is connected to the PAP device which deliver pressure to the upper airway during sleep.

LifeStyle Counseling: Subjects randomized to the lifestyle (and nutritional) counseling arm will be given advice on a balanced dietary and exercise plan.

Overall Number of Participants Analyzed 53 55
Mean (Standard Deviation)
Unit of Measure: [min]^-1
0.01498  (0.006408) 0.01537  (0.00636)
4.Secondary Outcome
Title Glucose Effectiveness (SG)
Hide Description Glucose effectiveness is the ability for glucose to move intracellularly in the absence of insulin. It is a parameter that results from the MINMOD analysis of the serum glucose and insulin levels derived from the frequently sampled intravenous glucose tolerance test. Low SG indicates a lower predisposition for glucose disposal independent of any effects of insulin.
Time Frame 2 months after intervention
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
55 randomized to PAP (2 dropout); 56 randomized to lifestyle (1 dropout)
Arm/Group Title Positive Pressure Therapy (PAP) Lifestyle Counseling
Hide Arm/Group Description:

Positive airway pressure(PAP) therapy is the standard of care for patients with obstructive sleep apnea. During sleep, a mask is worn over the nose and connected to the PAP machine.

Positive Pressure Therapy (PAP): Positive pressure therapy is the standard of care for managing obstructive sleep apnea. It entails wearing a mask that is connected to the PAP device which deliver pressure to the upper airway during sleep.

Positive Pressure Therapy (PAP): Positive pressure therapy is the standard of care for managing obstructive sleep apnea. It entails wearing a mask that is connected to the PAP device which deliver pressure to the upper airway during sleep.

LifeStyle Counseling: Subjects randomized to the lifestyle (and nutritional) counseling arm will be given advice on a balanced dietary and exercise plan.

Overall Number of Participants Analyzed 53 55
Mean (Standard Deviation)
Unit of Measure: [min]^-1
0.01720  (0.01094) 0.01385  (0.00636)
5.Secondary Outcome
Title Disposition Index (DI)
Hide Description The disposition index is the mathematical product of insulin sensitivity (SI) and acute insulin response to glucose (AIRG) both of which are derived from the MINMOD analysis of the frequently sampled intravenous glucose tolerance test data. A low DI is indicative of a higher risk of developing diabetes.
Time Frame Baseline
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
55 randomized to PAP (2 dropout); 56 randomized to lifestyle (1 dropout)
Arm/Group Title Positive Pressure Therapy (PAP) Lifestyle Counseling
Hide Arm/Group Description:

Positive airway pressure(PAP) therapy is the standard of care for patients with obstructive sleep apnea. During sleep, a mask is worn over the nose and connected to the PAP machine.

Positive Pressure Therapy (PAP): Positive pressure therapy is the standard of care for managing obstructive sleep apnea. It entails wearing a mask that is connected to the PAP device which deliver pressure to the upper airway during sleep.

Positive Pressure Therapy (PAP): Positive pressure therapy is the standard of care for managing obstructive sleep apnea. It entails wearing a mask that is connected to the PAP device which deliver pressure to the upper airway during sleep.

LifeStyle Counseling: Subjects randomized to the lifestyle (and nutritional) counseling arm will be given advice on a balanced dietary and exercise plan.

Overall Number of Participants Analyzed 53 55
Mean (Standard Deviation)
Unit of Measure: [mU/L]^-1 x [min]^-1] x [mU/L-min]
931.4  (957.1) 1093.1  (1037.9)
6.Secondary Outcome
Title Disposition Index (DI)
Hide Description The disposition index is the mathematical product of insulin sensitivity (SI) and acute insulin response to glucose (AIRG) both of which are derived from the MINMOD analysis of the frequently sampled intravenous glucose tolerance test data.
Time Frame 2 months after intervention
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
55 randomized to PAP (2 dropout); 56 randomized to lifestyle (1 dropout)
Arm/Group Title Positive Pressure Therapy (PAP) Lifestyle Counseling
Hide Arm/Group Description:

Positive airway pressure(PAP) therapy is the standard of care for patients with obstructive sleep apnea. During sleep, a mask is worn over the nose and connected to the PAP machine.

Positive Pressure Therapy (PAP): Positive pressure therapy is the standard of care for managing obstructive sleep apnea. It entails wearing a mask that is connected to the PAP device which deliver pressure to the upper airway during sleep.

Positive Pressure Therapy (PAP): Positive pressure therapy is the standard of care for managing obstructive sleep apnea. It entails wearing a mask that is connected to the PAP device which deliver pressure to the upper airway during sleep.

LifeStyle Counseling: Subjects randomized to the lifestyle (and nutritional) counseling arm will be given advice on a balanced dietary and exercise plan.

Overall Number of Participants Analyzed 53 55
Mean (Standard Deviation)
Unit of Measure: [mU/L]^-1 x [min]^-1] x [mU/L-min]
1385.9  (1670.1) 815.4  (579.5)
7.Secondary Outcome
Title Acute Insulin Response to Glucose (AIRG)
Hide Description The acute insulin response to glucose (AIRG) value is derived from the MINMOD analysis of the glucose and insulin levels obtained during the frequently sampled intravenous glucose tolerance test. A low AIRG indicates decreased ability of the pancreas to secrete insulin.
Time Frame Baseline
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
55 randomized to PAP (2 dropout); 56 randomized to lifestyle (1 dropout)
Arm/Group Title Positive Pressure Therapy (PAP) Lifestyle Counseling
Hide Arm/Group Description:

Positive airway pressure(PAP) therapy is the standard of care for patients with obstructive sleep apnea. During sleep, a mask is worn over the nose and connected to the PAP machine.

Positive Pressure Therapy (PAP): Positive pressure therapy is the standard of care for managing obstructive sleep apnea. It entails wearing a mask that is connected to the PAP device which deliver pressure to the upper airway during sleep.

Positive Pressure Therapy (PAP): Positive pressure therapy is the standard of care for managing obstructive sleep apnea. It entails wearing a mask that is connected to the PAP device which deliver pressure to the upper airway during sleep.

LifeStyle Counseling: Subjects randomized to the lifestyle (and nutritional) counseling arm will be given advice on a balanced dietary and exercise plan.

Overall Number of Participants Analyzed 53 55
Mean (Standard Deviation)
Unit of Measure: [mU/L-min]
537.48  (394.88) 632.38  (728.65)
8.Secondary Outcome
Title Acute Insulin Response to Glucose (AIRG)
Hide Description The acute insulin response to glucose (AIRG) value is derived from the MINMOD analysis of the glucose and insulin levels obtained during the frequently sampled intravenous glucose tolerance test. A low AIRG indicates decreased ability of the pancreas to secrete insulin.
Time Frame 2 months after intervention
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
55 randomized to PAP (2 dropout); 56 randomized to lifestyle (1 dropout)
Arm/Group Title Positive Pressure Therapy (PAP) Lifestyle Counseling
Hide Arm/Group Description:

Positive airway pressure(PAP) therapy is the standard of care for patients with obstructive sleep apnea. During sleep, a mask is worn over the nose and connected to the PAP machine.

Positive Pressure Therapy (PAP): Positive pressure therapy is the standard of care for managing obstructive sleep apnea. It entails wearing a mask that is connected to the PAP device which deliver pressure to the upper airway during sleep.

Positive Pressure Therapy (PAP): Positive pressure therapy is the standard of care for managing obstructive sleep apnea. It entails wearing a mask that is connected to the PAP device which deliver pressure to the upper airway during sleep.

LifeStyle Counseling: Subjects randomized to the lifestyle (and nutritional) counseling arm will be given advice on a balanced dietary and exercise plan.

Overall Number of Participants Analyzed 53 55
Mean (Standard Deviation)
Unit of Measure: [mU/L-min]
513.06  (338.41) 563.64  (546.20)
9.Secondary Outcome
Title Endothelial Function
Hide Description Endothelial function will be assessed using peripheral arterial tonometry using the Endo-PAT device. Using the EndoPat device, the relative vasoconstriction of occluded versus non-occluded arms was derived and provided the relative hyperemic index.
Time Frame Baseline
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Data was unable to be collected for all participants in this outcome measure.
Arm/Group Title Positive Pressure Therapy (PAP) Lifestyle Counseling
Hide Arm/Group Description:

Positive airway pressure(PAP) therapy is the standard of care for patients with obstructive sleep apnea. During sleep, a mask is worn over the nose and connected to the PAP machine.

Positive Pressure Therapy (PAP): Positive pressure therapy is the standard of care for managing obstructive sleep apnea. It entails wearing a mask that is connected to the PAP device which deliver pressure to the upper airway during sleep.

Positive Pressure Therapy (PAP): Positive pressure therapy is the standard of care for managing obstructive sleep apnea. It entails wearing a mask that is connected to the PAP device which deliver pressure to the upper airway during sleep.

LifeStyle Counseling: Subjects randomized to the lifestyle (and nutritional) counseling arm will be given advice on a balanced dietary and exercise plan.

Overall Number of Participants Analyzed 49 54
Mean (Standard Deviation)
Unit of Measure: ratio of occluded versus non-occluded
1.91  (0.46) 1.92  (0.49)
10.Secondary Outcome
Title Endothelial Function
Hide Description Endothelial function will be assessed using peripheral arterial tonometry using the Endo-PAT device. Using the EndoPat device, the relative vasoconstriction of occluded versus non-occluded arms was derived and provided the relative hyperemic index.
Time Frame 2 month after intervention
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Data was not collected for all participants for this outcome measure. Participants for whom data was available are included in analysis.
Arm/Group Title Positive Pressure Therapy (PAP) Lifestyle Counseling
Hide Arm/Group Description:

Positive airway pressure(PAP) therapy is the standard of care for patients with obstructive sleep apnea. During sleep, a mask is worn over the nose and connected to the PAP machine.

Positive Pressure Therapy (PAP): Positive pressure therapy is the standard of care for managing obstructive sleep apnea. It entails wearing a mask that is connected to the PAP device which deliver pressure to the upper airway during sleep.

Positive Pressure Therapy (PAP): Positive pressure therapy is the standard of care for managing obstructive sleep apnea. It entails wearing a mask that is connected to the PAP device which deliver pressure to the upper airway during sleep.

LifeStyle Counseling: Subjects randomized to the lifestyle (and nutritional) counseling arm will be given advice on a balanced dietary and exercise plan.

Overall Number of Participants Analyzed 49 54
Mean (Standard Deviation)
Unit of Measure: ratio
1.90  (0.53) 1.91  (0.46)
11.Secondary Outcome
Title Area Under the Curve Assessed by Oral Glucose Tolerance Test
Hide Description Results of the oral glucose tolerance test will be analyzed using indices derived from the serial glucose and insulin levels over the 2 hour period. This will be the area under the glucose/ insulin curves
Time Frame Baseline
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
55 randomized to PAP (2 dropout); 56 randomized to lifestyle (1 dropout)
Arm/Group Title Positive Pressure Therapy (PAP) Lifestyle Counseling
Hide Arm/Group Description:

Positive airway pressure(PAP) therapy is the standard of care for patients with obstructive sleep apnea. During sleep, a mask is worn over the nose and connected to the PAP machine.

Positive Pressure Therapy (PAP): Positive pressure therapy is the standard of care for managing obstructive sleep apnea. It entails wearing a mask that is connected to the PAP device which deliver pressure to the upper airway during sleep.

Positive Pressure Therapy (PAP): Positive pressure therapy is the standard of care for managing obstructive sleep apnea. It entails wearing a mask that is connected to the PAP device which deliver pressure to the upper airway during sleep.

LifeStyle Counseling: Subjects randomized to the lifestyle (and nutritional) counseling arm will be given advice on a balanced dietary and exercise plan.

Overall Number of Participants Analyzed 53 55
Mean (Standard Deviation)
Unit of Measure: mg/dL per 120 min
7939.9  (3327.8) 7245.31  (2988.4)
12.Secondary Outcome
Title Area Under the Curve Assessed by Oral Glucose Tolerance Test (OGTT)
Hide Description Results of the oral glucose tolerance test will be analyzed using indices derived from the serial glucose and insulin levels over a 2 hour period 2 months post intervention. This will be the area under the glucose/ insulin curves
Time Frame 2 month after intervention
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
55 randomized to PAP (2 dropout); 56 randomized to lifestyle (1 dropout)
Arm/Group Title Positive Pressure Therapy (PAP) Lifestyle Counseling
Hide Arm/Group Description:

Positive airway pressure(PAP) therapy is the standard of care for patients with obstructive sleep apnea. During sleep, a mask is worn over the nose and connected to the PAP machine.

Positive Pressure Therapy (PAP): Positive pressure therapy is the standard of care for managing obstructive sleep apnea. It entails wearing a mask that is connected to the PAP device which deliver pressure to the upper airway during sleep.

Positive Pressure Therapy (PAP): Positive pressure therapy is the standard of care for managing obstructive sleep apnea. It entails wearing a mask that is connected to the PAP device which deliver pressure to the upper airway during sleep.

LifeStyle Counseling: Subjects randomized to the lifestyle (and nutritional) counseling arm will be given advice on a balanced dietary and exercise plan.

Overall Number of Participants Analyzed 53 55
Mean (Standard Deviation)
Unit of Measure: mg/dL per 120 min
7531.8  (3179.2) 7655.1  (3057.6)
Time Frame up to 4 months after enrollment in study
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Positive Pressure Therapy (PAP) Lifestyle Counseling
Hide Arm/Group Description

Positive airway pressure(PAP) therapy is the standard of care for patients with obstructive sleep apnea. During sleep, a mask is worn over the nose and connected to the PAP machine.

Positive Pressure Therapy (PAP): Positive pressure therapy is the standard of care for managing obstructive sleep apnea. It entails wearing a mask that is connected to the PAP device which deliver pressure to the upper airway during sleep.

Positive Pressure Therapy (PAP): Positive pressure therapy is the standard of care for managing obstructive sleep apnea. It entails wearing a mask that is connected to the PAP device which deliver pressure to the upper airway during sleep.

LifeStyle Counseling: Subjects randomized to the lifestyle (and nutritional) counseling arm will be given advice on a balanced dietary and exercise plan.

All-Cause Mortality
Positive Pressure Therapy (PAP) Lifestyle Counseling
Affected / at Risk (%) Affected / at Risk (%)
Total   0/55 (0.00%)   0/56 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Positive Pressure Therapy (PAP) Lifestyle Counseling
Affected / at Risk (%) Affected / at Risk (%)
Total   0/55 (0.00%)   0/56 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Positive Pressure Therapy (PAP) Lifestyle Counseling
Affected / at Risk (%) Affected / at Risk (%)
Total   0/55 (0.00%)   0/56 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Naresh Punjabi
Organization: Johns Hopkins University
Phone: 410-550-6384
Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01503164     History of Changes
Other Study ID Numbers: NA_00036672
2R01HL075078 ( U.S. NIH Grant/Contract )
First Submitted: December 29, 2011
First Posted: January 2, 2012
Results First Submitted: August 10, 2017
Results First Posted: October 19, 2017
Last Update Posted: October 19, 2017