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Analysis was not done because only 1 subject was able to come back for the 3 month follow up visit.
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The hypothesis for this study is that children with sleep disordered breathing will benefit from treatment with Continuous Positive Airway Pressure (CPAP) or Bi-level Positive Airway Pressure (BiPAP) in terms of reduction in cardiovascular risk markers and insulin resistance.
The CPAP machine delivers a predetermined level of pressure. It releases a stream of compressed air through a hose to the nose mask and keeps the upper airway open under continuous air pressure. This air pressure prevents obstructive sleep apnea, which occurs as a result of narrowing of the airway due to the relaxation of upper respiratory tract muscles during sleep. This machine helps to increase the oxygen flow by keeping the airway open.
The BiPAP machine delivers two levels of pressure. Inspiratory Positive Airway Pressure (IPAP) is a high amount of pressure, applied when the patient inhales and a low Expiratory Positive Airway Pressure (EPAP) during exhalation.
Obese children with Moderate to Severe Sleep Apnea will have baseline evaluation of markers of cardiometabolic risk and insulin resistance. Subjects will then use either the CPAP or BiPAP machine for 3 months and will return for another blood draw for measurement of the markers for cardiometabolic risk and insulin resistance.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CPAP/Bi-PAP | Experimental | Subjects will be treated with either CPAP or Bi-PAP for three months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CPAP/BiPAP | Device | Subjects will be treated with either CPAP or Bi-PAP for three months. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Level of Fasting Glucose | baseline, 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Level of Fasting Insulin | baseline, 3 months | |
| Change in Level of Lipids | baseline, 3 months |
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Inclusion Criteria:
Only patients who provide informed assent or consent and also have consent from a parent will be included.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Seema Kumar, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
11 subjects with a high probability of Obstructive Sleep Apnea (OSA) were consented, and all had a baseline blood draw. 2 subjects had a normal sleep study. 9 subjects had a polysomnogram suggestive of OSA, and were given the intervention of 3 months of Continuous Positive Airway Pressure (CPAP) or Bi-Level Positive Airway Pressure (Bi-PAP) use.
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| ID | Title | Description |
|---|---|---|
| FG000 | CPAP/Bi-PAP | Subjects will be treated with either CPAP or Bi-PAP for three months. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | CPAP/Bi-PAP | Subjects will be treated with either CPAP or Bi-PAP for three months. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Change in Level of Fasting Glucose | Only one participant returned for the 3 month visit. | Posted | baseline, 3 months |
|
|
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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/Bi-PAP | Subjects will be treated with either CPAP or Bi-PAP for three months. |
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Analysis was not done because only 1 subject was able to come back for the 3 month follow up visit.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Seema Kumar | Mayo Clinic | 507-538-2724 | kumar.seema@mayo.edu |
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| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| ID | Term |
|---|---|
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
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| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Secondary | Change in Level of Fasting Insulin | Only one participant returned for the 3 month visit. | Posted | baseline, 3 months |
|
|
| Secondary | Change in Level of Lipids | Only one participant returned for the 3 month visit. | Posted | baseline, 3 months |
|
|
| 0 |
| 9 |
| 0 |
| 9 |
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| D020920 |
| Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |