Assessment Of The Effects Of Short and Long Term Use Of CPAP
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ClinicalTrials.gov Identifier: NCT00592631 |
Recruitment Status :
Terminated
(Key investigator resigned)
First Posted : January 14, 2008
Results First Posted : February 10, 2016
Last Update Posted : February 10, 2016
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Condition or disease | Intervention/treatment | Phase |
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Asthma | Device: CPAP-Continuous Positive Airway Pressure Device: SHAM | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 27 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Basic Science |
Official Title: | Assessment of the Effects of Short and Long Term Use of Continuous Positive Airway Pressure on Airway Reactivity in Children and Adults With and Without Asthma |
Study Start Date : | February 2005 |
Actual Primary Completion Date : | June 2012 |
Actual Study Completion Date : | June 2012 |
Arm | Intervention/treatment |
---|---|
Experimental: CPAP
Subjects will use CPAP of 8-12 during days 2 through 6 of the study.
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Device: CPAP-Continuous Positive Airway Pressure
Cpap will be worn at night by subjects 6 to 7 days duration. |
Sham Comparator: SHAM
Subjects will use sham CPAP of 0-2 during days 2 through 6 of the study.
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Device: SHAM
SHAM will be worn at night by subjects 6 to 7 days duration. |
- Change in Provocative Concentration of Methacholine Causing a 20% Fall in Forced Expiratory Volume in 1 Second (FEV1) [ Time Frame: 7 to 10 nights after cpap is started. ]Methacholine is an inhaled medication used to assess asthma and reactive airways. It was given at increasing concentrations (beginning with 0.0625 mg/ml and ending with 16.0 mg/ml). Each dose was followed by a lung measurement until a change of FEV1 of 20% occurs or until a maximum dose was reached, whichever came first.

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Ages Eligible for Study: | 8 Years to 60 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Inclusion criteria for children 8-18
- 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
Inclusion criteria adults 18-60
- 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.
Exclusion Criteria:
Exclusions for Children category age 8-18 include:
- Cyanotic congenital heart disease.
- History of acute respiratory symptoms for 3 weeks prior to testing.
- Inability to perform pulmonary function testing adequately.
- Escalation in asthma medication at time of recruitment.
- SaO2 <93% while awake and breathing room air
- Baseline FEV1 <75% predicted
Exclusions for adults 18-60 include:
- Gastro-Esophageal Reflux requiring Medical management.
- Chronic Obstructive Pulmonary Disease.
- Use of Supplemental Oxygen.
- Ischemic Heart Disease or Hypertension requiring treatment with medications other than diuretics.
- Use of systemic corticosteroid therapy during the past 6 months.
- Acute Respiratory Illness in the previous 8 weeks.
Exclusions/Inclusion criteria for adults with asthma include:
- Juniper Score <1.5
- Baseline FEV1 > or equal to 70%
- Non-smoking for 6 months
- Less than 10 pack year smoking history
- No change in asthma medications for the last 2 months
- Negative pregnancy test
- Subject cannot have sleep apnea

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00592631
United States, Indiana | |
Riley Hospital for Children | |
Indianapolis, Indiana, United States, 46202 |
Principal Investigator: | Robert S. Tepper, MD, PhD | Indiana University | |
Study Director: | Mike Busk, MD | NIFS/ Indiana University |
Responsible Party: | Indiana University |
ClinicalTrials.gov Identifier: | NCT00592631 |
Other Study ID Numbers: |
0405-16 0405-16 |
First Posted: | January 14, 2008 Key Record Dates |
Results First Posted: | February 10, 2016 |
Last Update Posted: | February 10, 2016 |
Last Verified: | January 2016 |
asthma sleep apnea |
Asthma Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases |
Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases |