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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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Positive Pressure Therapy (PAP)

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

Participant Flow:   Overall Study
    Positive Pressure Therapy (PAP)   Lifestyle Counseling
STARTED   55   56 
COMPLETED   53   55 
NOT COMPLETED   2   1 
Withdrawal by Subject                2                1 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
55 randomized to PAP (2 dropout); 56 randomized to lifestyle (1 dropout)

Reporting Groups
  Description
Positive Pressure Therapy (PAP)

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

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 Total of all reporting groups

Baseline Measures
   Positive Pressure Therapy (PAP)   Lifestyle Counseling   Total 
Overall Participants Analyzed 
[Units: Participants]
 53   55   108 
Age 
[Units: Participants]
Count of 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 
[Units: Years]
Mean (Standard Deviation)
 54.8  (9.2)   57.2  (8.2)   56.0  (8.8) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      12  22.6%      16  29.1%      28  25.9% 
Male      41  77.4%      39  70.9%      80  74.1% 
Region of Enrollment 
[Units: Participants]
Count of Participants
     
United States   53   55   108 


  Outcome Measures

1.  Primary:   Insulin Sensitivity (SI)   [ Time Frame: Baseline ]

2.  Primary:   Insulin Sensitivity (SI)   [ Time Frame: 2 months after intervention ]

3.  Secondary:   Glucose Effectiveness (SG)   [ Time Frame: Baseline ]

4.  Secondary:   Glucose Effectiveness (SG)   [ Time Frame: 2 months after intervention ]

5.  Secondary:   Disposition Index (DI)   [ Time Frame: Baseline ]

6.  Secondary:   Disposition Index (DI)   [ Time Frame: 2 months after intervention ]

7.  Secondary:   Acute Insulin Response to Glucose (AIRG)   [ Time Frame: Baseline ]

8.  Secondary:   Acute Insulin Response to Glucose (AIRG)   [ Time Frame: 2 months after intervention ]

9.  Secondary:   Endothelial Function   [ Time Frame: Baseline ]

10.  Secondary:   Endothelial Function   [ Time Frame: 2 month after intervention ]

11.  Secondary:   Area Under the Curve Assessed by Oral Glucose Tolerance Test   [ Time Frame: Baseline ]

12.  Secondary:   Area Under the Curve Assessed by Oral Glucose Tolerance Test (OGTT)   [ Time Frame: 2 month after intervention ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

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
e-mail: npunjabi@jhmi.edu


Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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