Sleep Disordered Breathing
Conditions
Keywords
Sleep Disordered Breathing, CPAP, BiPAP, Cardiovascular risk markers
Brief summary
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.
Detailed description
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.
Interventions
DEVICECPAP/BiPAP
Subjects will be treated with either CPAP or Bi-PAP for three months.
Sponsors
Mayo Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
8 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
1. Body mass index greater than 95th percentile for age and gender 2. Moderate to severe obstructive sleep apnea (OSA) (as defined by an apnea-hypopnea index (AHI) score of ≥5 events per hour). Only patients who provide informed assent or consent and also have consent from a parent will be included.
Exclusion criteria
1. Predominant central sleep apnea 2. Type 1 Diabetes 3. Type 2 Diabetes 4. Requires use of supplemental oxygen 5. Active infection, cancer, or chronic inflammatory disorder 6. Use of systemic steroids 7. Simultaneous use of peroxisome proliferator-activated receptor (PPAR)-alpha (e.g., gemfibrozil, fenofibrate) or PPAR-gamma (e.g., rosiglitazone, pioglitazone)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Level of Fasting Glucose | baseline, 3 months |
Secondary
| Measure | Time frame |
|---|---|
| Change in Level of Fasting Insulin | baseline, 3 months |
| Change in Level of Lipids | baseline, 3 months |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| CPAP/Bi-PAP Subjects will be treated with either CPAP or Bi-PAP for three months. | 11 |
| Total | 11 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 8 |
| Overall Study | Screen Failure | 2 |
Baseline characteristics
| Characteristic | CPAP/Bi-PAP |
|---|---|
| Age, Categorical <=18 years | 11 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Region of Enrollment United States | 11 participants |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 9 |
| serious Total, serious adverse events | 0 / 9 |
Outcome results
Primary
Change in Level of Fasting Glucose
Time frame: baseline, 3 months
Population: Only one participant returned for the 3 month visit.
Secondary
Change in Level of Fasting Insulin
Time frame: baseline, 3 months
Population: Only one participant returned for the 3 month visit.
Secondary
Change in Level of Lipids
Time frame: baseline, 3 months
Population: Only one participant returned for the 3 month visit.