Effect of CPAP (Continuous Positive Airway Pressure) on L... | NCT00238069

Studies
Effect of CPAP (Continuous Positive Airway Pressure) on Lung Function in Asthmatics With Sleep Apnea

NCT00238069

Sponsor

National Jewish Health

Status

Completed

Last Update Posted

Mar 29, 2017Actual

Enrollment

20Actual

Phase

Not Applicable

Conditions

Asthma
Sleep Apnea

Interventions

CPAP machine as a result of sleep study

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2004

Primary Completion Date

Aug 2005Actual

Completion Date

Aug 2005Actual

First Submitted Date

Oct 11, 2005

First Submission Date that Met QC Criteria

Oct 11, 2005

First Posted Date

Oct 13, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 27, 2017

Last Update Posted Date

Mar 29, 2017Actual

Description Module

Brief Summary

This is a research study of asthma and sleep apnea. Our hypothesis is that untreated sleep apnea causes inflammation in the lung, which can worsen asthma. We believe treatment of sleep apnea will reduce this inflammation, and improve asthma control. This study will help us better understand what happens to the lung and bronchial tubes before and after treatment of sleep apnea, which could benefit all patients with sleep apnea. This study involves 2 bronchoscopies.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Name	Type	Description	Arm Group Labels	Other Names
CPAP machine as a result of sleep study	Device

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Systemic inflammatory markers will include IL-6, IL-8, CRP, and TNF-α.
Exhaled breath condensate levels of IL-6 and 8-isporostane will be measured.
BAL (bronchial lavage) fluid cell count and differential, IL-6, IL-8, and TNF- α will be measured.
Endobronchial biopsies to analyze extent and type of inflammatory cell.

Secondary Outcomes

Measure	Description	Time Frame
Symptoms, albuterol use and daily morning and evening peak expiratory flows from diary cards.
Spirometry measured at three time points: before, during, and after CPAP therapy.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adult (>18yrs at the time of recruitment)
Body mass index (BMI) ≥ 30
Symptoms suggestive of sleep apnea
Epworth Sleepiness Score (ESS) within range
Positive sleep study for sleep apnea

Exclusion Criteria:

Tobacco use within the last 3 months.
Presence of other significant comorbid heart or lung disease
Presence of another chronic inflammatory disease, such as connective-tissue disease, inflammatory bowel disease, or active infection.
Use of systemic steroids, as defined as any prednisone use in the preceding 3 months.
Use of leukotriene antagonists or theophylline within the preceding 6 weeks.
Presence of severe or uncontrolled sinusitis, such that CPAP therapy will be difficult or uncomfortable.
History of significant claustrophobia, uncontrolled psychiatric disease, or anticipated intolerance of CPAP therapy.
Night shift workers, or other subjects with significantly altered sleep-wake cycles.
Baseline post-bronchodilator FEV1 < 70% predicted.
Severe gastroesophageal reflux disease.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Richard Martin, MD	National Jewish Medical and Research Center faculty	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
National Jewish Medical and Research Center		Denver	Colorado	80206	United States

Condition Browse Module

MeSH Terms

ID	Term
D001249	Asthma
D012891	Sleep Apnea Syndromes
D009765	Obesity

Ancestor Terms

ID	Term
D001982	Bronchial Diseases
D012140	Respiratory Tract Diseases
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases

Browse Leaves

Not provided

Browse Branches

Not provided