Continuous Positive Airway Pressure and Cardiometabolic Risk

NCT01403194 | Terminated Results

• 1 other identifier: 10-004698
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep Disordered Breathing

Keywords

Sleep Disordered Breathing; CPAP; BiPAP; Cardiovascular risk markers

Outcome Measures

Primary Outcomes (1)

• Change in Level of Fasting Glucose

  baseline, 3 months

Secondary Outcomes (2)

• Change in Level of Fasting Insulin

  baseline, 3 months

• Change in Level of Lipids

  baseline, 3 months

Study Arms (1)

CPAP/Bi-PAP

EXPERIMENTAL

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

Device: CPAP/BiPAP

Interventions

CPAP/BiPAP DEVICE

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

CPAP/Bi-PAP

Eligibility Criteria

• Age: 8 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Sleep Apnea Syndromes

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Limitations and Caveats

Analysis was not done because only 1 subject was able to come back for the 3 month follow up visit.

Results Point of Contact

• Title: Dr. Seema Kumar
• Organization: Mayo Clinic

kumar.seema@mayo.edu

507-538-2724

Study Officials

• Seema Kumar, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 6, 2011
• First Posted: July 27, 2011
• Study Start: March 1, 2011
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: May 13, 2014
• Results First Posted: May 13, 2014

Record last verified: 2014-04

Locations

US (1)