Assessment Of The Effects Of Short and Long Term Use Of CPAP

NCT ID: NCT00592631

Last Updated: 2016-02-10

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-02-28
• Study Completion Date: 2012-06-30

Brief Summary

We hypothesize that the nocturnal use of continuous positive airway pressure in adults and children with asthma will decrease airway reactivity.

Detailed Description

Deep inspirations have been shown to decrease the sensitivity of airways to narrowing (airway reactivity) after inhalation of agents that induce constriction of the bronchi in healthy adults. This response is absent in adult asthmatics; however, there is data demonstrating that use of continuous positive airway pressure (CPAP) for short periods of time may decrease airway reactivity in adult asthmatics. This suggests that although deep inspirations may not result in decreased airway reactivity, sustained lung inflation may lead to changes in asthmatic airway smooth muscle structure that lead to a decrease in airway reactivity. The purpose of our study is to determine whether short and long term use of CPAP in children and adults leads to decreased airway reactivity. If airway reactivity is decreased with CPAP, this may provide a novel therapeutic strategy for patients with asthma.

Conditions

Asthma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

CPAP

Subjects will use CPAP of 8-12 during days 2 through 6 of the study.

Group Type: EXPERIMENTAL

CPAP-Continuous Positive Airway Pressure

Intervention Type: DEVICE

Cpap will be worn at night by subjects 6 to 7 days duration.

SHAM

Subjects will use sham CPAP of 0-2 during days 2 through 6 of the study.

Group Type: SHAM_COMPARATOR

SHAM

Intervention Type: DEVICE

SHAM will be worn at night by subjects 6 to 7 days duration.

Interventions

CPAP-Continuous Positive Airway Pressure

Cpap will be worn at night by subjects 6 to 7 days duration.

Intervention Type: DEVICE

SHAM

SHAM will be worn at night by subjects 6 to 7 days duration.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Children 8-18 years of age scheduled to start CPAP for obstructive sleep apnea.
• Subjects can have clinically stable asthma, with no plans by their physician to change asthma therapy over the next month

• Adults 18-60 years of age, seen in adult Pulmonary Clinic for sleep related problems who may require treatment with nocturnal continuous positive pressure (CPAP), which will be determined by polysomnography(PSG) will be approached to participate in the study.

1. Juniper Score <1.5

2. Baseline FEV1 > or equal to 70%

3. Non-smoking for 6 months

4. Less than 10 pack year smoking history

5. No change in asthma medications for the last 2 months

6. Negative pregnancy test

7. Subject cannot have sleep apnea

Exclusion Criteria

Exclusions for Children category age 8-18 include:

1. Cyanotic congenital heart disease.

2. History of acute respiratory symptoms for 3 weeks prior to testing.

3. Inability to perform pulmonary function testing adequately.

4. Escalation in asthma medication at time of recruitment.

5. SaO2 <93% while awake and breathing room air

6. Baseline FEV1 <75% predicted

Exclusions for adults 18-60 include:

1. Gastro-Esophageal Reflux requiring Medical management.

2. Chronic Obstructive Pulmonary Disease.

3. Use of Supplemental Oxygen.

4. Ischemic Heart Disease or Hypertension requiring treatment with medications other than diuretics.

5. Use of systemic corticosteroid therapy during the past 6 months.

6. Acute Respiratory Illness in the previous 8 weeks.

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Indiana University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Robert S. Tepper, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Indiana University

Mike Busk, MD

Role: STUDY_DIRECTOR

NIFS/ Indiana University

Locations

Riley Hospital for Children

Indianapolis, Indiana, United States

Countries

United States

References

Busk M, Busk N, Puntenney P, Hutchins J, Yu Z, Gunst SJ, Tepper RS. Use of continuous positive airway pressure reduces airway reactivity in adults with asthma. Eur Respir J. 2013 Feb;41(2):317-22. doi: 10.1183/09031936.00059712. Epub 2012 Jul 26.

Reference Type: DERIVED

PMID: 22835615 (View on PubMed)

Other Identifiers

0405-16

Identifier Type: -

Identifier Source: secondary_id

0405-16

Identifier Type: -

Identifier Source: org_study_id