Obstructive Sleep ApneaMIICNCT02824263

Metabolic Impact of Intermittent CPAP

A study testing CPAP withdrawal in people with Obstructive Sleep Apnea, run by Johns Hopkins University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 20 to 75 years
Conditions the study is for: Obstructive Sleep Apnea
What is being tested?: CPAP withdrawal
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 144 participants
Where: 1 siteUnited States
Study dates: 10 Jul 2016to 1 Dec 2022
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 20 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

History of moderate to severe Obstructive sleep apnea (OSA) (AHI or respiratory disturbance index (RDI)> 10).
They must also own a CPAP machine and report the ability to tolerate sleeping with or without CPAP during the night.

Who cannot join

Uncontrolled hypertension with systolic blood pressure >170 or diastolic blood pressure > 110
Congestive heart failure
Use of clonidine or nicotinic acid medication
Diabetes requiring the use of insulin
Known pregnancy, by urine testing in women of child-bearing age
History of falling asleep while driving, near miss
High risk occupation (pilot, commercial driver)
Hemoglobin < 10 g/dL on point of care screening

Trial locations and contacts

1 site in 1 country.

United States1 site

Johns Hopkins Bayview Medical Center
Baltimore, Maryland, 21224

Other trials in United States

About this study

Obstructive sleep apnea is a risk factor for diabetes and cardiovascular disease, by unknown mechanisms. The investigators hypothesize that sleep apnea changes glucose and lipid metabolism during sleep, which over time could lead to diabetes and cardiovascular disease. This study examines metabolic changes during sleep in patients with obstructive sleep apnea. Patients accustomed to continuous positive airway pressure (CPAP) therapy are enrolled to undergo sleep studies, either on CPAP therapy or after withdrawing from CPAP for 3 nights. During sleep, blood samples are obtained so that metabolic function can be compared between sleep apnea and CPAP nights.

Read the detailed description

Participants with a history of moderate severe sleep apnea (AHI>20) will be enrolled if participants meet inclusion/exclusion criteria. Investigators will report to the sleep laboratory on two nights, (1) after continuing their CPAP or (2) after discontinuing CPAP for 3 nights. The order of observation will be randomized. A standard research dinner is provided before each study. IV's are placed so that blood can be sampled at frequent (30 min) intervals throughout the night. In the morning after each study, a glucose tolerance test and endothelial function study (endoPAT) are performed. Serum samples will be analyzed for glucose, insulin, free fatty acids, triglycerides, hormones, and other metabolic biomarkers.

Conditions: Obstructive Sleep Apnea
Being tested: CPAP withdrawal
Keywords: obstructive sleep apnea, CPAP, metabolism
Medical subject headings: Sleep Apnea, Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CPAP withdrawalOther
CPAP is discontinued for 3 nights.

Study groups in NCT02824263
Study group	Role	What they receive
CPAP (Usual care)	No intervention	Continuation of established CPAP therapy. CPAP will be worn during a metabolic sleep study in the research laboratory.
CPAP withdrawal;	Experimental	Cessation of established CPAP therapy for 3 nights. CPAP will NOT be worn during this period, and a metabolic sleep study off CPAP is performed in the research laboratory on the third night. Receives: Other: CPAP withdrawal

What is being measured

The primary outcome is the main question the study is designed to answer.

Concentration of Plasma Free Fatty Acids (FFA, mmol/L)
We will report the mean for all participants per group (CPAP vs. CPAP withdrawal).
Measured: 2 nights, <1 month apart. Data from each night was averaged to report a single value.
Concentration of Plasma Glucose (mg/dl)
We will report the mean for all participants per group (CPAP vs. CPAP withdrawal).
Measured: 2 nights, <1 month apart. Data from each night was averaged to report a single value.
Concentration of Plasma Insulin (mcU/ml)
We will report the mean for all participants per group (CPAP vs. CPAP withdrawal).
Measured: 2 nights, <1 month apart. Data from each night was averaged to report a single value.
Concentration of Plasma Triglycerides (mg/dl)
We will report the mean for all participants per group (CPAP vs. CPAP withdrawal).
Measured: 2 nights, <1 month apart. Data from each night was averaged to report a single value.

Secondary outcomes (3)

Oral Glucose Tolerance Test (OGTT)
We will report the mean of the area under the curve (AUC) during OGTT for all participants per group (CPAP vs. CPAP withdrawal).
Measured: 2 nights, <1 month apart. 5 OGTT values were averaged to a obtain a single value.
Reactive Hyperemia Index (RHI)
Measured in the morning using Itamar EndoPAT device. This will measure the ratio of blood flow after brachial artery occlusion to blood flow prior to brachial artery occlusion. Normal values range from approximately 1 to 3 with higher values being associated with better vascular function. We will report the mean for all participants per group (CPAP vs. CPAP withdrawal).
Measured: 2 nights, <1 month apart, 1 measurement each visit
Augmentation Index (AI)
Measured in the morning using Itamar EndoPAT device. Augmentation index is measured once during each visit, and is expressed as a % increase in the pressure waveform during systole. We will report the mean for all participants per group (CPAP vs. CPAP withdrawal).
Measured: 2 nights, <1 month apart, 1 measurement each visit

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 Jul 20161 Dec 2022

First posted6 Jul 2016 (estimated)
Study start10 Jul 2016
Primary completion1 Dec 2022
Study completion1 Dec 2022

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 (1)Papers the sponsor has linked to this study.
Other trials for Obstructive 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: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 144 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02824263
Sponsor's protocol ID: NA_00086830
Other IDs: R01HL135483
Acronym: MIIC
Status last verified: Sep 2026
First submitted: 18 Mar 2016
Last updated: 25 Sep 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Chopra S, Rathore A, Younas H, Pham LV, Gu C, Beselman A, Kim IY, Wolfe RR, Perin J, Polotsky VY, Jun JC. Obstructive Sleep Apnea Dynamically Increases Nocturnal Plasma Free Fatty Acids, Glucose, and Cortisol During Sleep. J Clin Endocrinol Metab. 2017 Sep 1;102(9):3172-3181. doi: 10.1210/jc.2017-00619.
PubMed 28595341

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
Development and Validation of a Multimodal Deep Learning Model Using Peripheral Oxygen Saturation and Ballistocardiography Signals for Predicting Apnea-Hypopnea Index in Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 3
A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Do Not Use a Breathing Machine (PAP) (VESPER-OSA 2)
Apnea, Sleep Disorders
Not yet recruitingPhase 2
Supplemental Oxygen for Sleep-Disordered Breathing in Adults With Chronic Opioid Use.
Sleep-disordered Breathing, Chronic Opioid Use
Recruiting
Nightly Wearable Monitoring During Home-Based Submental Electrical Stimulation for Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 1/2
DRonabinol Treatment of OSA
Obstructive Sleep Apnea

All Obstructive Sleep Apnea trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Metabolic Impact of Intermittent CPAP
ClinicalTrials.gov ID: NCT02824263
Acronym / sponsor ID: MIIC / NA_00086830
Conditions: Obstructive Sleep Apnea
Keywords: obstructive sleep apnea, CPAP, metabolism
Study type: Interventional
Recruitment status: Completed
Enrolment: 144 participants (actual)
Lead sponsor: Johns Hopkins UniversityUniversity, hospital or other
Collaborators: National Heart, Lung, and Blood Institute (NHLBI), American Academy of Sleep Medicine
Study start: 10 Jul 2016 (actual)
Primary completion: 1 Dec 2022 (actual)
Study completion: 1 Dec 2022 (actual)
First posted: 6 Jul 2016 (estimated)
Results: Posted 2 Jan 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
CPAP (Usual care)	No intervention	–Continuation of established CPAP therapy. CPAP will be worn during a metabolic sleep study in the research laboratory.
CPAP withdrawal;	Experimental	Other: CPAP withdrawalCessation of established CPAP therapy for 3 nights. CPAP will NOT be worn during this period, and a metabolic sleep study off CPAP is performed in the research laboratory on the third night.

Who may qualify

Ages: 20 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

History of moderate to severe Obstructive sleep apnea (OSA) (AHI or respiratory disturbance index (RDI)> 10).
They must also own a CPAP machine and report the ability to tolerate sleeping with or without CPAP during the night.

Key exclusion criteria (8 listed)

Uncontrolled hypertension with systolic blood pressure >170 or diastolic blood pressure > 110
Congestive heart failure
Use of clonidine or nicotinic acid medication
Diabetes requiring the use of insulin
Known pregnancy, by urine testing in women of child-bearing age

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
CPAP withdrawalCPAP is discontinued for 3 nights.	Other	CPAP withdrawal;

Primary outcome

Concentration of Plasma Free Fatty Acids (FFA, mmol/L)
Time frame: 2 nights, <1 month apart. Data from each night was averaged to report a single value.
We will report the mean for all participants per group (CPAP vs. CPAP withdrawal).
Concentration of Plasma Glucose (mg/dl)
Time frame: 2 nights, <1 month apart. Data from each night was averaged to report a single value.
We will report the mean for all participants per group (CPAP vs. CPAP withdrawal).
Concentration of Plasma Insulin (mcU/ml)
Time frame: 2 nights, <1 month apart. Data from each night was averaged to report a single value.
We will report the mean for all participants per group (CPAP vs. CPAP withdrawal).
Concentration of Plasma Triglycerides (mg/dl)
Time frame: 2 nights, <1 month apart. Data from each night was averaged to report a single value.
We will report the mean for all participants per group (CPAP vs. CPAP withdrawal).

3 secondary outcomes

Oral Glucose Tolerance Test (OGTT)
Time frame: 2 nights, <1 month apart. 5 OGTT values were averaged to a obtain a single value.
Reactive Hyperemia Index (RHI)
Time frame: 2 nights, <1 month apart, 1 measurement each visit
Augmentation Index (AI)
Time frame: 2 nights, <1 month apart, 1 measurement each visit

Results and safety

Results posted to the registry on 2 Jan 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
CPAP First, Then OSA (CPAP Withdrawal)	71	71
OSA First (CPAP Withdrawal), Then CPAP	64	64

Primary outcome: Concentration of Plasma Free Fatty Acids (FFA, mmol/L)

Time frame: 2 nights, <1 month apart. Data from each night was averaged to report a single value.. Mean (Standard Deviation). Unit: mmol/L

Measure	CPAP n = 109	CPAP Withdrawal n = 109
Value	0.47 (14)	0.51 (0.12)

Population analysed: missing values due to IV issues leading to incomplete collection.

Primary outcome: Concentration of Plasma Glucose (mg/dl)

Time frame: 2 nights, <1 month apart. Data from each night was averaged to report a single value.. Mean (Standard Deviation). Unit: mg/dl

Measure	CPAP n = 109	CPAP Withdrawal n = 109
Value	100 (18)	101 (21)

Population analysed: missing values due to IV issues leading to incomplete collection.

Primary outcome: Concentration of Plasma Insulin (mcU/ml)

Time frame: 2 nights, <1 month apart. Data from each night was averaged to report a single value.. Mean (Standard Deviation). Unit: microunits/mL

Measure	CPAP n = 110	CPAP Withdrawal n = 110
Value	18 (8)	18 (12)

Population analysed: missing values due to IV issues leading to incomplete collection.

Primary outcome: Concentration of Plasma Triglycerides (mg/dl)

Time frame: 2 nights, <1 month apart. Data from each night was averaged to report a single value.. Mean (Standard Deviation). Unit: mg/dl

Measure	CPAP n = 108	CPAP Withdrawal n = 108
Value	127 (65)	128 (74)

Population analysed: Missing values due to IV issues leading to incomplete collection.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Participants were assessed for adverse events beginning 3 days before each visit to screen for drowsiness related incidents. The longest duration for assessing adverse events was approximately 4 weeks (if visits 1 and 2 were 1 month apart).. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
CPAP	0 of 129 (0%)	2 of 129 (1.6%)	0 of 129
CPAP Withdrawal	0 of 129 (0%)	0 of 129 (0%)	0 of 129

Limitations and caveats (from the sponsor): Not all participants who completed both study visits were included in the published analyses. Exclusions were primarily due to incomplete data collection - most commonly IV/blood draw failure preventing collection of metabolic outcome measures, and technical issues affecting EndoPAT vascular function measurements. The published analytic sample (N=97, pooled pilot and extension phases) is smaller than the number who completed the protocol (N=117) for these reasons.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 28595341Chopra S, Rathore A, Younas H, Pham LV, Gu C, Beselman A, Kim IY, Wolfe RR, Perin J, Polotsky VY, Jun JC. Obstructive Sleep Apnea Dynamically Increases Nocturnal Plasma Free Fatty Acids, Glucose, and Cortisol During Sleep. J Clin Endocrinol Metab. 2017 Sep 1;102(9):3172-3181. doi: 10.1210/jc.2017-00619.
Individual participant dataSharing planned: No

Related trials for Obstructive Sleep Apnea

RecruitingObservational study
Development and Validation of a Multimodal Deep Learning Model Using Peripheral Oxygen Saturation and Ballistocardiography Signals for Predicting Apnea-Hypopnea Index in Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 3
A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Do Not Use a Breathing Machine (PAP) (VESPER-OSA 2)
Apnea, Sleep Disorders
Not yet recruitingPhase 2
Supplemental Oxygen for Sleep-Disordered Breathing in Adults With Chronic Opioid Use.
Sleep-disordered Breathing, Chronic Opioid Use
Recruiting
Nightly Wearable Monitoring During Home-Based Submental Electrical Stimulation for Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 1/2
DRonabinol Treatment of OSA
Obstructive Sleep Apnea

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.

Jonathan C Jun, MD 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 CPAP withdrawal in people with Obstructive Sleep Apnea, 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 8 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 Sep 2026. 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 2 Jan 2024). 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?

Concentration of Plasma Free Fatty Acids (FFA, mmol/L) (time frame: 2 nights, <1 month apart. Data from each night was averaged to report a single value.). The study lists 4 primary outcomes in all. 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 NCT02824263, which also lists 1 linked publication.

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 Sep 2026.