Continuous Positive Airway Pressure and Cardiometabolic Risk

This study has been terminated.
(Analysis was not done because only 1 subject was able to come back for the 3 month follow up visit.)
Sponsor:
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01403194
First received: April 6, 2011
Last updated: April 14, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention
Sleep Disordered Breathing
Device: CPAP/BiPAP

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

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Change in Level of Fasting Glucose [ Time Frame: baseline, 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in Level of Fasting Insulin [ Time Frame: baseline, 3 months ] [ Designated as safety issue: No ]
  • Change in Level of Lipids [ Time Frame: baseline, 3 months ] [ Designated as safety issue: No ]

Enrollment: 11
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/Bi-PAP
Subjects will be treated with either CPAP or Bi-PAP for three months.
Device: CPAP/BiPAP
Subjects will be treated with either CPAP or Bi-PAP for three months.

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

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 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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Results First Received: April 14, 2014
Last Updated: April 14, 2014
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
Pathologic Processes
Apnea
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on August 28, 2014