Continuous Positive Airway Pressure and Cardiometabolic Risk

Sleep Disordered Breathing Clinical Trial

Official title:

Impact of Treatment of Sleep Disordered Breathing With Continuous Positive Airway Pressure (CPAP) on Cardiometabolic Risk Markers

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01403194
• Other study ID #: 10-004698
• Status: Terminated
• Phase: N/A
• First received: April 6, 2011
• Last updated: April 14, 2014
• Start date: March 2011
• Est. completion date: January 2013

Study information

• Verified date: April 2014
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 11
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 8 Years to 18 Years

Eligibility

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)

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Respiratory Aspiration
• Sleep Disordered Breathing

Intervention

Device:
• CPAP/BiPAP
Subjects will be treated with either CPAP or Bi-PAP for three months.

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Level of Fasting Glucose		baseline, 3 months	No
Secondary	Change in Level of Fasting Insulin		baseline, 3 months	No
Secondary	Change in Level of Lipids		baseline, 3 months	No