Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Hyperglycemic Profiles in Obstructive Sleep Apnea: Effects of PAP Therapy (HYPNOS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02454153
Recruitment Status : Recruiting
First Posted : May 27, 2015
Last Update Posted : February 8, 2019
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Johns Hopkins University

Tracking Information
First Submitted Date  ICMJE January 14, 2015
First Posted Date  ICMJE May 27, 2015
Last Update Posted Date February 8, 2019
Actual Study Start Date  ICMJE December 2014
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 26, 2015)
Continuous Glucose Monitoring System Standard Deviation [ Time Frame: 3 months ]
Continuous Glucose Monitoring Metrics
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02454153 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 26, 2015)
  • Blood pressure [ Time Frame: 3 months ]
  • Endothelial Dysfunction (Reactive hyperemic index) [ Time Frame: 3 months ]
    Endothelial function as measured by the EndoPAT device
  • Heart Rate Variability [ Time Frame: 3 months ]
  • Epworth Sleepiness Scale [ Time Frame: 3 months ]
    Self-reported daytime sleepiness using the Epworth Sleepiness Scale
  • Post-Pre meal increment from self-monitoring of blood glucose [ Time Frame: 3 months ]
    Self monitoring of blood glucose
  • Glycosylated hemoglobin [ Time Frame: 3 months ]
    HbA1c
  • Continuous Glucose Monitoring System Mean Amplitude Glucose Excursion [ Time Frame: 3 months ]
    Continuous Glucose Monitoring Metrics
  • Continuous Glucose Monitoring System Standard Deviation [ Time Frame: 3 months ]
    Continues Glucose Monitoring Metrics
  • Continuous Glucose Monitoring System Mean Glucose [ Time Frame: 3 months ]
    Continuous Glucose Monitoring Metrics
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Hyperglycemic Profiles in Obstructive Sleep Apnea: Effects of PAP Therapy
Official Title  ICMJE Hyperglycemic Profiles in Obstructive Sleep Apnea: Effects of PAP Therapy
Brief Summary This is a randomized control trial in people with diabetes and obstructive sleep apnea who will be randomly assigned for 3 months to PAP therapy along with healthy lifestyle and sleep education or healthy lifestyle and sleep education.
Detailed Description Research over the last decade has shown that obstructive sleep apnea (OSA) is a common condition in people with diabetes. Observational and experimental evidence also indicates that intermittent hypoxemia and recurrent arousals in OSA may alter glucose metabolism and worsen glycemic control. However, the impact of treating OSA with positive airway pressure (PAP) therapy on glycemic variability and control is not well defined. Adequately powered randomized clinical trials have yet to be performed to demonstrate whether PAP therapy for OSA in diabetics can improve glycemic variability (and control), decrease blood pressure, and reverse endothelial dysfunction. The overarching goal of this study is to determine whether PAP therapy for OSA in diabetics leads to improvements in (a) glycemic variability as assessed by self-monitoring of blood glucose and continuous monitoring of glucose; (b) glycosylated hemoglobin; (c) blood pressure; (d) endothelial function; (e) serum and urinary biomarkers; and (f) dyslipidemia.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Sleep Apnea
  • Diabetes
Intervention  ICMJE
  • Device: REMStar Postive Airway Pressure
    Positive airway pressure therapy is the standard of care for managing obstructive sleep apnea
  • Behavioral: LifeStyle Counseling
    Lifestyle guidelines developed by the American Diabetes Association for weight loss will be provided to all subjects.
Study Arms  ICMJE
  • Active Comparator: REMStar Postive Airway Pressure
    Positive pressure therapy is the standard of care for managing obstructive sleep apnea.
    Intervention: Device: REMStar Postive Airway Pressure
  • LifeStyle Counseling
    Lifestyle guidelines developed by the American Diabetes Association for weight loss will be provided to all subjects.
    Intervention: Behavioral: LifeStyle Counseling
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 26, 2015)
204
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2019
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Type 2 diabetics
  • Age > 21 and ≤ 75 years

Exclusion Criteria:

  • Inability to consent or commit to the required visits
  • Use of insulin or other injections for diabetes
  • Weight change of 10% in last six months
  • Use of oral steroids in the last six months
  • Pulmonary disease (i.e., COPD)
  • Renal or hepatic insufficiency
  • Recent MI or stroke (< 3 months)
  • Sleep-related hypoventilation
  • Obesity-hypoventilation syndrome
  • Morbid Obesity
  • Occupation as a commercial driver or operator of heavy machinery
  • Active substance use
  • Untreated thyroid disease
  • Pregnancy
  • Any history of seizures or other neurologic disease
  • Poor sleep hygiene or sleep disorder other than sleep apnea
  • Central sleep apnea
  • Variants of obstructive sleep apnea (e.g., REM-related OSA)
  • Participants not suitable for the study based on the clinical judgment
  • Use of any investigational drug within the past 30 days
  • Participating in another study
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Naresh M Punjabi, MD, PhD 410-550-4891 npunjabi@jhmi.edu
Contact: Nisha Aurora, MD 410-550-4891 raurora2@jhmi.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02454153
Other Study ID Numbers  ICMJE NA_00093188
R01HL117167 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Johns Hopkins University
Study Sponsor  ICMJE Johns Hopkins University
Collaborators  ICMJE National Heart, Lung, and Blood Institute (NHLBI)
Investigators  ICMJE Not Provided
PRS Account Johns Hopkins University
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP