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 : August 14, 2017
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Johns Hopkins University

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.

Condition or disease Intervention/treatment Phase
Sleep Apnea Diabetes Device: REMStar Postive Airway Pressure Behavioral: LifeStyle Counseling Not Applicable

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 204 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Hyperglycemic Profiles in Obstructive Sleep Apnea: Effects of PAP Therapy
Actual Study Start Date : December 2014
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

Arm Intervention/treatment
Active Comparator: REMStar Postive Airway Pressure
Positive pressure therapy is the standard of care for managing obstructive sleep apnea.
Device: REMStar Postive Airway Pressure
Positive airway pressure therapy is the standard of care for managing obstructive sleep apnea

LifeStyle Counseling
Lifestyle guidelines developed by the American Diabetes Association for weight loss will be provided to all subjects.
Behavioral: LifeStyle Counseling
Lifestyle guidelines developed by the American Diabetes Association for weight loss will be provided to all subjects.




Primary Outcome Measures :
  1. Continuous Glucose Monitoring System Standard Deviation [ Time Frame: 3 months ]
    Continuous Glucose Monitoring Metrics


Secondary Outcome Measures :
  1. Blood pressure [ Time Frame: 3 months ]
  2. Endothelial Dysfunction (Reactive hyperemic index) [ Time Frame: 3 months ]
    Endothelial function as measured by the EndoPAT device

  3. Heart Rate Variability [ Time Frame: 3 months ]
  4. Epworth Sleepiness Scale [ Time Frame: 3 months ]
    Self-reported daytime sleepiness using the Epworth Sleepiness Scale

  5. Post-Pre meal increment from self-monitoring of blood glucose [ Time Frame: 3 months ]
    Self monitoring of blood glucose

  6. Glycosylated hemoglobin [ Time Frame: 3 months ]
    HbA1c

  7. Continuous Glucose Monitoring System Mean Amplitude Glucose Excursion [ Time Frame: 3 months ]
    Continuous Glucose Monitoring Metrics

  8. Continuous Glucose Monitoring System Standard Deviation [ Time Frame: 3 months ]
    Continues Glucose Monitoring Metrics

  9. Continuous Glucose Monitoring System Mean Glucose [ Time Frame: 3 months ]
    Continuous Glucose Monitoring Metrics



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   21 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02454153


Contacts
Contact: Naresh M Punjabi, MD, PhD 410-550-4891 npunjabi@jhmi.edu
Contact: Nisha Aurora, MD 410-550-4891 raurora2@jhmi.edu

Locations
United States, Maryland
Johns Hopkins Bayview Medical Center Recruiting
Baltimore, Maryland, United States, 21224
Contact: Naresh M Punjabi, MD, PhD    410-550-4891    npunjabi@jhmi.edu   
Contact: Nisha Aurora, MD    410-550-4891    raurora2@jhmi.edu   
Principal Investigator: Naresh M Punjabi, MD, PhD         
Sponsors and Collaborators
Johns Hopkins University
National Heart, Lung, and Blood Institute (NHLBI)

Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT02454153     History of Changes
Other Study ID Numbers: NA_00093188
R01HL117167 ( U.S. NIH Grant/Contract )
First Posted: May 27, 2015    Key Record Dates
Last Update Posted: August 14, 2017
Last Verified: August 2017

Additional relevant MeSH terms:
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Dyssomnias
Nervous System Diseases