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| ID | Type | Description | Link |
|---|---|---|---|
| R01HL135483 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
| American Academy of Sleep Medicine | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CPAP withdrawal | Other | CPAP is discontinued for 3 nights. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Concentration of Plasma Free Fatty Acids (FFA, mmol/L) | We will report the mean for all participants per group (CPAP vs. CPAP withdrawal). | 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). | 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). | 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). | 2 nights, <1 month apart. Data from each night was averaged to report a single value. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 2 nights, <1 month apart. 5 OGTT values were averaged to a obtain a single value. |
| Reactive Hyperemia Index (RHI) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jonathan C Jun, MD | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins Bayview Medical Center | Baltimore | Maryland | 21224 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28595341 | Derived | 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. |
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144 participants signed a consent form. 15 subjects withdrew or were lost to follow up after consent, leaving 129 participants who were randomized to CPAP first (61) or CPAP withdrawal first (68) visits.
Patients with a history of obstructive sleep apnea (OSA) who were accustomed to CPAP use were enrolled from the Johns Hopkins Sleep Disorders Center.
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| ID | Title | Description |
|---|---|---|
| FG000 | CPAP First, Then OSA (CPAP Withdrawal) | This is a crossover study comparing effects of sleep apnea (CPAP withdrawal) vs CPAP. Participants first underwent a CPAP study (continuation of established CPAP therapy) during 1 overnight visit in the sleep lab. After a washout of 1 to 4 weeks, they then had a OSA (CPAP withdrawal) study during 1 overnight visit in the sleep lab. |
| FG001 | OSA First (CPAP Withdrawal), Then CPAP | This is a crossover study comparing effects of sleep apnea (CPAP withdrawal) vs CPAP. Participants first underwent an OSA (CPAP withdrawal) study during 1 overnight visit in the sleep lab. After a washout of 1 to 4 weeks, they then had a CPAP (continuation of established CPAP therapy) study during 1 overnight visit in the sleep lab. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention (1 Night) |
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| Washout (1 to 4 Weeks) |
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| Second Intervention (1 Night) |
|
144 participants signed a consent form, but 15 were lost to follow up before visit 1. Therefore the baseline characteristics reflect 129 participants who had demographic information collected.
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| ID | Title | Description |
|---|---|---|
| BG000 | CPAP First, Then OSA (CPAP Withdrawal) | This is a crossover study comparing effects of sleep apnea (CPAP withdrawal) vs CPAP. Participants in this arm undergo a (1) CPAP study (continuation of established CPAP therapy), followed by a (2) CPAP withdrawal study. |
| BG001 | OSA First (CPAP Withdrawal), Then CPAP |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Concentration of Plasma Free Fatty Acids (FFA, mmol/L) | We will report the mean for all participants per group (CPAP vs. CPAP withdrawal). | missing values due to IV issues leading to incomplete collection. | Posted | Mean | Standard Deviation | mmol/L | 2 nights, <1 month apart. Data from each night was averaged to report a single value. |
|
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).
The risks of the study are related to IV access, temporary discontinuation of CPAP for 3 nights resulting in possible drowsiness-related incidents
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | CPAP | This is a crossover study comparing effects of sleep apnea (CPAP withdrawal) vs CPAP. Participants are randomized to two arms. Either CPAP (continuation of established CPAP therapy), followed by a CPAP withdrawal OR CPAP withdrawal, followed by CPAP (continuation of established CPAP therapy) |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diverticulitis | Gastrointestinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jonathan Jun | Johns Hopkins University School of Medicine | 410-550-0115 | jjun2@jhmi.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 23, 2021 | Oct 6, 2023 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 2, 2021 | Oct 6, 2023 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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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). |
| 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). | 2 nights, <1 month apart, 1 measurement each visit |
| NOT COMPLETED |
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| NOT COMPLETED |
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This is a crossover study comparing effects of sleep apnea (CPAP withdrawal) vs CPAP. Participants in this arm undergo a (1) CPAP withdrawal study, followed by a (2) CPAP study (continuation of established CPAP therapy). |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Diabetes status | Count of Participants | Participants |
|
| History of hypertension | Count of Participants | Participants |
|
This is a crossover study comparing effects of sleep apnea (CPAP withdrawal) vs CPAP.
Participants are randomized to two arms. Either CPAP (continuation of established CPAP therapy), followed by a CPAP withdrawal
OR
CPAP withdrawal, followed by CPAP (continuation of established CPAP therapy)
|
|
| Primary | Concentration of Plasma Glucose (mg/dl) | We will report the mean for all participants per group (CPAP vs. CPAP withdrawal). | missing values due to IV issues leading to incomplete collection. | Posted | Mean | Standard Deviation | mg/dl | 2 nights, <1 month apart. Data from each night was averaged to report a single value. |
|
|
|
| Primary | Concentration of Plasma Insulin (mcU/ml) | We will report the mean for all participants per group (CPAP vs. CPAP withdrawal). | missing values due to IV issues leading to incomplete collection. | Posted | Mean | Standard Deviation | microunits/mL | 2 nights, <1 month apart. Data from each night was averaged to report a single value. |
|
|
|
| Primary | Concentration of Plasma Triglycerides (mg/dl) | We will report the mean for all participants per group (CPAP vs. CPAP withdrawal). | Missing values due to IV issues leading to incomplete collection. | Posted | Mean | Standard Deviation | mg/dl | 2 nights, <1 month apart. Data from each night was averaged to report a single value. |
|
|
|
| Secondary | 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). | Missing values due to IV issues leading to incomplete collection. | Posted | Mean | Standard Deviation | mg/dl*min | 2 nights, <1 month apart. 5 OGTT values were averaged to a obtain a single value. |
|
|
|
| Secondary | 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). | Some missing data due to technical problems during collection of EndoPAT data. | Posted | Mean | Standard Deviation | Ratio | 2 nights, <1 month apart, 1 measurement each visit |
|
|
|
| Secondary | 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). | Some missing data due to technical problems during collection of EndoPAT data. | Posted | Mean | Standard Deviation | percentage | 2 nights, <1 month apart, 1 measurement each visit |
|
|
|
| 0 |
| 129 |
| 0 |
| 129 |
| 2 |
| 129 |
| EG001 | CPAP Withdrawal | This is a crossover study comparing effects of sleep apnea (CPAP withdrawal) vs CPAP. Participants are randomized to two arms. Either CPAP (continuation of established CPAP therapy), followed by a CPAP withdrawal OR CPAP withdrawal, followed by CPAP (continuation of established CPAP therapy) | 0 | 129 | 0 | 129 | 0 | 129 |
| Blood pressure elevation | Cardiac disorders | Non-systematic Assessment | was related to non-study related changes to medication |
|
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| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |