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Continuous Positive Airway Pressure and Cardiometabolic Risk

Primary Purpose

Sleep Disordered Breathing

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CPAP/BiPAP
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Sleep Disordered Breathing focused on measuring Sleep Disordered Breathing, CPAP, BiPAP, Cardiovascular risk markers

Eligibility Criteria

8 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Mayo Clinic

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CPAP/Bi-PAP

Arm Description

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

Outcomes

Primary Outcome Measures

Change in Level of Fasting Glucose

Secondary Outcome Measures

Change in Level of Fasting Insulin
Change in Level of Lipids

Full Information

First Posted
April 6, 2011
Last Updated
April 14, 2014
Sponsor
Mayo Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT01403194
Brief Title
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

2. Study Status

Record Verification Date
April 2014
Overall Recruitment Status
Terminated
Why Stopped
Analysis was not done because only 1 subject was able to come back for the 3 month follow up visit.
Study Start Date
March 2011 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
January 2013 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Mayo Clinic

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Disordered Breathing
Keywords
Sleep Disordered Breathing, CPAP, BiPAP, Cardiovascular risk markers

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
11 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CPAP/Bi-PAP
Arm Type
Experimental
Arm Description
Subjects will be treated with either CPAP or Bi-PAP for three months.
Intervention Type
Device
Intervention Name(s)
CPAP/BiPAP
Intervention Description
Subjects will be treated with either CPAP or Bi-PAP for three months.
Primary Outcome Measure Information:
Title
Change in Level of Fasting Glucose
Time Frame
baseline, 3 months
Secondary Outcome Measure Information:
Title
Change in Level of Fasting Insulin
Time Frame
baseline, 3 months
Title
Change in Level of Lipids
Time Frame
baseline, 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Body mass index greater than 95th percentile for age and gender 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: Predominant central sleep apnea Type 1 Diabetes Type 2 Diabetes Requires use of supplemental oxygen Active infection, cancer, or chronic inflammatory disorder Use of systemic steroids Simultaneous use of peroxisome proliferator-activated receptor (PPAR)-alpha (e.g., gemfibrozil, fenofibrate) or PPAR-gamma (e.g., rosiglitazone, pioglitazone)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Seema Kumar, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States

12. IPD Sharing Statement

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Continuous Positive Airway Pressure and Cardiometabolic Risk

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