Clinical trial NCT01403194: Continuous Positive Airway Pressure and Cardiometabolic Risk
Official title: Impact of Treatment of Sleep Disordered Breathing With Continuous Positive Airway Pressure (CPAP) on Cardiometabolic Risk Markers
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Sleep Disordered Breathing
Keywords: Sleep Disordered Breathing
CPAP
BiPAP
Cardiovascular risk markers
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2011-07-27
Enrollment: 11
Sex: ALL
Minimum age (years): 8
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Change in Level of Fasting Glucose
timeFrame: baseline, 3 months
Secondary outcomes:
measure: Change in Level of Fasting Insulin
timeFrame: baseline, 3 months
measure: Change in Level of Lipids
timeFrame: baseline, 3 months
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Seema Kumar, MD
role: PRINCIPAL_INVESTIGATOR
References: