Sleep ApneaHYPNOSNCT02454153
Hyperglycemic Profiles in Obstructive Sleep Apnea: Effects of PAP Therapy
A study testing REMStar Positive Airway Pressure and LifeStyle Counseling in people with Sleep Apnea and Diabetes, run by Johns Hopkins University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 75 years
- Conditions the study is for
- Sleep Apnea, Diabetes
- What is being tested?
- REMStar Positive Airway Pressure and LifeStyle Counseling
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 184 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2014to 15 Mar 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 2 diabetics
- Age > 21 and ≤ 75 years
Who cannot join
- 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
Show all 21Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, 21224
About this study
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.
Read the 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.
- Conditions
- Sleep Apnea, Diabetes
- Being tested
- REMStar Positive Airway Pressure, LifeStyle Counseling
- Medical subject headings
- Sleep Apnea Syndromes, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
REMStar Positive Airway PressureDevice
Positive airway pressure therapy is the standard of care for managing obstructive sleep apnea
LifeStyle CounselingBehavioural
Lifestyle guidelines developed by the American Diabetes Association for weight loss will be provided to all subjects.
| Study group | Role | What they receive |
|---|---|---|
| REMStar Positive Airway Pressure | Active comparator | Positive pressure therapy is the standard of care for managing obstructive sleep apnea. Receives: Device: REMStar Positive Airway Pressure |
| LifeStyle Counseling | Other | Lifestyle guidelines developed by the American Diabetes Association for weight loss will be provided to all subjects. Receives: Behavioral: LifeStyle Counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Continuous Glucose Monitoring System Standard Deviation
Continuous Glucose Monitoring Metrics - change in standard deviation between baseline and three months.
Measured: Baseline and 3 months
Secondary outcomes (9)
Mean Difference in Systolic Blood Pressure
Mean difference between 3 months and baseline systolic blood pressures (in mmHg) by group.
Measured: Baseline and 3 months
Change in Endothelial Dysfunction as Assessed by the Reactive Hyperemic Index
Endothelial function was measured by the EndoPAT device - difference at 3 months - baseline, by group. The outcome reported is the Reactive Hyperemic Index (RHI). The RHI is a measure of endothelial vasodilator function. The RHI is the post-to-pre occlusion peripheral arterial tone signal ratio in the occluded arm relative to the other arm, which is not occluded. Persons with worse endothelial function have a lower RHI score. Consequently, a low RHI indicates more endothelial dysfunction. A value of 1.67 or less is considered abnormal vascular tone. The reported lower and upper limits in adults with type 2 diabetes is 1.1 - 4.9.
Measured: Baseline and 3 months
Heart Rate Variability
Measured: 3 months
Change in the Epworth Sleepiness Scale
The Epworth Sleepiness Scale measures self-reported sleep propensity or daytime sleepiness. The range of the scale is 0 to 24 (integers only), with increasing values corresponding to increasing sleepiness. A cut-point of ≥ 11 is also sometimes used to differentiate those with pathological sleepiness (≥ 11) versus those without < 11. The difference between the three month final visit - the baseline visit score is reported by group
Measured: Baseline and 3 months
Change in Post-Pre Meal Blood Glucose Levels
The difference from baseline to three months in self-reported in blood glucose levels before and after meals (mg/dL) (post-meal - pre-meal). Data is presented for breakfast, lunch, and dinner.
Measured: Baseline and 3 months
Change in Glycosylated Hemoglobin A1c Level
Change in point-of-care hemoglobin A1c (%) after three months.
Measured: Baseline and 3 months
Continuous Glucose Monitoring System Mean Amplitude Glucose Excursion
Mean Amplitude Glucose Excursion in mg/dL (difference between the peaks and troughs of glucose from continuous glucose monitoring at three months).
Measured: 3 months
Continuous Glucose Monitoring System Standard Deviation
The standard deviation of the glucose from continuous glucose monitoring at three months.
Measured: 3 months
Change in Continuous Glucose Monitoring System Mean Glucose
Continuous Glucose Monitoring Metric - change in average glucose level (mg/dL) from baseline to three months.
Measured: Baseline and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2015 (estimated)
- Study startDec 2014
- Primary completion15 Mar 2020
- Study completion15 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Sleep ApneaStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 184 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Naresh M Punjabi, MD, PhD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02454153
- Sponsor's protocol ID
- NA_00093188
- Other IDs
- R01HL117167
- Acronym
- HYPNOS
- Status last verified
- May 2021
- First submitted
- 14 Jan 2015
- Last updated
- 25 May 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 37062349Fang 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.
PubMed 36738249Selvin 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.
PubMed 36495162Selvin 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.
PubMed 36108310Rooney 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.
PubMed 33316455
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hyperglycemic Profiles in Obstructive Sleep Apnea: Effects of PAP Therapy
- ClinicalTrials.gov ID
- NCT02454153
- Acronym / sponsor ID
- HYPNOS / NA_00093188
- Conditions
- Sleep Apnea, Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 184 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Dec 2014 (actual)
- Primary completion
- 15 Mar 2020 (actual)
- Study completion
- 15 Mar 2020 (actual)
- First posted
- 27 May 2015 (estimated)
- Results
- Posted 25 May 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| REMStar Positive Airway Pressure | Active comparator | Device: REMStar Positive Airway PressurePositive pressure therapy is the standard of care for managing obstructive sleep apnea. |
| LifeStyle Counseling | Other | Behavioral: LifeStyle CounselingLifestyle guidelines developed by the American Diabetes Association for weight loss will be provided to all subjects. |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Type 2 diabetics
- Age > 21 and ≤ 75 years
Key exclusion criteria (21 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| REMStar Positive Airway PressurePositive airway pressure therapy is the standard of care for managing obstructive sleep apnea | Device | REMStar Positive Airway Pressure |
| LifeStyle CounselingLifestyle guidelines developed by the American Diabetes Association for weight loss will be provided to all subjects. | Behavioural | LifeStyle Counseling |
Primary outcome
Change in Continuous Glucose Monitoring System Standard Deviation
Time frame: Baseline and 3 months
Continuous Glucose Monitoring Metrics - change in standard deviation between baseline and three months.
9 secondary outcomes
Mean Difference in Systolic Blood Pressure
Time frame: Baseline and 3 months
Change in Endothelial Dysfunction as Assessed by the Reactive Hyperemic Index
Time frame: Baseline and 3 months
Heart Rate Variability
Time frame: 3 months
Change in the Epworth Sleepiness Scale
Time frame: Baseline and 3 months
Change in Post-Pre Meal Blood Glucose Levels
Time frame: Baseline and 3 months
Change in Glycosylated Hemoglobin A1c Level
Time frame: Baseline and 3 months
Continuous Glucose Monitoring System Mean Amplitude Glucose Excursion
Time frame: 3 months
Continuous Glucose Monitoring System Standard Deviation
Time frame: 3 months
Change in Continuous Glucose Monitoring System Mean Glucose
Time frame: Baseline and 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37062349Aurora 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.
- Derived from this study: PubMed 36738249Fang 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.
- Derived from this study: PubMed 36495162Selvin 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.
- Derived from this study: PubMed 36108310Selvin 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.
- Derived from this study: PubMed 33316455Rooney 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Naresh M Punjabi, MD, PhD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing REMStar Positive Airway Pressure and LifeStyle Counseling in people with Sleep Apnea and Diabetes, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 May 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Continuous Glucose Monitoring System Standard Deviation (time frame: Baseline and 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02454153, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2021.