Hyperglycemic Profiles in Obstructive Sleep Apnea: Effects of PAP Therapy
HYPNOS
2 other identifiers
interventional
184
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2014
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2014
CompletedFirst Submitted
Initial submission to the registry
January 14, 2015
CompletedFirst Posted
Study publicly available on registry
May 27, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 15, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
March 15, 2020
CompletedResults Posted
Study results publicly available
May 25, 2021
CompletedMay 25, 2021
May 1, 2021
5.3 years
January 14, 2015
March 15, 2021
May 3, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Change in Continuous Glucose Monitoring System Standard Deviation
Continuous Glucose Monitoring Metrics - change in standard deviation between baseline and three months.
Baseline and 3 months
Secondary Outcomes (9)
Mean Difference in Systolic Blood Pressure
Baseline and 3 months
Change in Endothelial Dysfunction as Assessed by the Reactive Hyperemic Index
Baseline and 3 months
Heart Rate Variability
3 months
Change in the Epworth Sleepiness Scale
Baseline and 3 months
Change in Post-Pre Meal Blood Glucose Levels
Baseline and 3 months
- +4 more secondary outcomes
Study Arms (2)
REMStar Positive Airway Pressure
ACTIVE COMPARATORPositive pressure therapy is the standard of care for managing obstructive sleep apnea.
LifeStyle Counseling
OTHERLifestyle guidelines developed by the American Diabetes Association for weight loss will be provided to all subjects.
Interventions
Positive airway pressure therapy is the standard of care for managing obstructive sleep apnea
Lifestyle guidelines developed by the American Diabetes Association for weight loss will be provided to all subjects.
Eligibility Criteria
You may qualify if:
- Type 2 diabetics
- Age \> 21 and ≤ 75 years
You may not qualify if:
- 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
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, 21224, United States
Related Publications (5)
Aurora RN, Rooney MR, Wang D, Selvin E, Punjabi NM. Effects of Positive Airway Pressure Therapy on Glycemic Variability in Patients With Type 2 Diabetes and OSA: A Randomized Controlled Trial. Chest. 2023 Oct;164(4):1057-1067. doi: 10.1016/j.chest.2023.04.017. Epub 2023 Apr 14.
PMID: 37062349DERIVEDFang M, Wang D, Rooney MR, Echouffo-Tcheugui JB, Coresh J, Aurora RN, Punjabi NM, Selvin E. Performance of the Glucose Management Indicator (GMI) in Type 2 Diabetes. Clin Chem. 2023 Apr 3;69(4):422-428. doi: 10.1093/clinchem/hvac210.
PMID: 36738249DERIVEDSelvin E, Wang D, Rooney MR, Fang M, Echouffo-Tcheugui JB, Zeger S, Sartini J, Tang O, Coresh J, Nisha Aurora R, Punjabi NM. Within-Person and Between-Sensor Variability in Continuous Glucose Monitoring Metrics. Clin Chem. 2023 Feb 1;69(2):180-188. doi: 10.1093/clinchem/hvac192.
PMID: 36495162DERIVEDSelvin E, Wang D, Rooney MR, Echouffo-Tcheugui J, Fang M, Zeger S, Sartini J, Tang O, Coresh J, Aurora RN, Punjabi NM. The Associations of Mean Glucose and Time in Range from Continuous Glucose Monitoring with HbA1c in Adults with Type 2 Diabetes. Diabetes Technol Ther. 2023 Jan;25(1):86-90. doi: 10.1089/dia.2022.0178. Epub 2022 Nov 23.
PMID: 36108310DERIVEDRooney MR, Aurora RN, Wang D, Selvin E, Punjabi NM. Rationale and design of the Hyperglycemic Profiles in Obstructive Sleep Apnea (HYPNOS) trial. Contemp Clin Trials. 2021 Feb;101:106248. doi: 10.1016/j.cct.2020.106248. Epub 2020 Dec 11.
PMID: 33316455DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Naresh M. Punjabi
- Organization
- Johns Hopkins University
Study Officials
- PRINCIPAL INVESTIGATOR
Naresh M Punjabi, MD, PhD
Johns Hopkins University
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 14, 2015
First Posted
May 27, 2015
Study Start
December 1, 2014
Primary Completion
March 15, 2020
Study Completion
March 15, 2020
Last Updated
May 25, 2021
Results First Posted
May 25, 2021
Record last verified: 2021-05