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Continuous Positive Airway Pressure and Cardiometabolic Risk

This study has been completed.
Sponsor:
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01403194
First received: April 6, 2011
Last updated: February 25, 2013
Last verified: February 2013
History of Changes
  Purpose

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.


Condition Intervention
Sleep Disordered Breathing
 Device: CPAP

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Impact of Treatment of Sleep Disordered Breathing With Continuous Positive Airway Pressure (CPAP)on Cardiometabolic Risk Markers

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • To determine the impact of treatment of SDB with Continuous Positive Airway Pressure (CPAP) or Bi-level Positive Airway Pressure (BiPAP) on cardiometabolic risk markers [ Time Frame: 12-16 weeks ] [ Designated as safety issue: No ]
    Labs tests including insulin, insulin resistance and oxidative stress markers.


Secondary Outcome Measures:
  • To determine the impact of treatment of SDB with CPAP or BiPAP on proinflammatory and anti-inflammatory cytokines [ Time Frame: 12-16 weeks. ] [ Designated as safety issue: No ]

Enrollment: 10
Study Start Date: March 2011
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CPAP
CPAP for three months
 Device: CPAP
Continuous Airway Positive Airway Pressure for three months

Detailed Description:

Obese children with Moderate to Severe Sleep Apnea would have baseline evaluation of markers of cardiometabolic risk and insulin resistance. Subjects will then use CPAP for 3 months and will return for another blood draw for measurement of the markers for cardiometabolic risk and insulin resistance.

  Eligibility

Ages Eligible for Study:   8 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Body mass index greater than 95th percentile for age and gender
  2. Moderate to severe 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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01403194

Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Seema Kumar, MD Mayo Clinic
  More Information

No publications provided

Responsible Party: Seema Kumar, MD, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01403194     History of Changes
Other Study ID Numbers: 10-004698
Study First Received: April 6, 2011
Last Updated: February 25, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Mayo Clinic:
Sleep Disordered Breathing
CPAP
BiPAP
Cardiovascular risk markers

Additional relevant MeSH terms:
Respiratory Aspiration
Sleep Apnea Syndromes
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
 Apnea
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on May 23, 2013