Continuous Positive Airway Pressure and Cardiometabolic Risk

NCT ID: NCT01403194

Last Updated: 2014-05-13

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-03-31
• Study Completion Date: 2013-01-31

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.

Conditions

Sleep Disordered Breathing

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

CPAP/Bi-PAP

Subjects will be treated with either CPAP or Bi-PAP for three months.

Group Type: EXPERIMENTAL

CPAP/BiPAP

Intervention Type: DEVICE

Subjects will be treated with either CPAP or Bi-PAP for three months.

Interventions

CPAP/BiPAP

Subjects will be treated with either CPAP or Bi-PAP for three months.

Intervention Type: DEVICE

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)

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Mayo Clinic

Principal Investigators

Seema Kumar, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic

Rochester, Minnesota, United States

Countries

United States

Other Identifiers

10-004698

Identifier Type: -

Identifier Source: org_study_id