Asthma and Obstructive Sleep Apnea (OSA)

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by University of Wisconsin, Madison
Sponsor:
Information provided by (Responsible Party):
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT01026298
First received: December 2, 2009
Last updated: February 11, 2014
Last verified: February 2014
  Purpose

Obstructive sleep apnea (OSA) is a common but under-diagnosed form of sleep disordered breathing (SDB). Asthma is a common disease with rising prevalence, which continues to pose significant morbidity and costs. In spite of considerable progress in our understanding of asthma, a large number of individuals with asthma continue to have symptoms and subsequently, have a poor functional status, poor quality of life and increased health care costs. In many cases no apparent cause is found and optimal therapy does not achieve its goal. While recent data suggests that OSA is common in severe asthma, the prevalence of OSA and its predisposing factors have not been studied.


Condition Intervention
Asthma
Obstructive Sleep Apnea
Other: FDA-Approved Treatment

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: The Relationship Between Asthma and Obstructive Sleep Apnea (OSA) - A Pilot Study of the Effects of OSA and Its Treatment on Asthma

Resource links provided by NLM:


Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:
  • To determine the prevalence and risk factors for OSA symptoms in a specialty clinic-based sample of individuals with asthma. [ Time Frame: 7 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To assess changes in subjective and objective asthma measures in subjects with asthma and co-morbid OSA, after 8 weeks of treatment with continuous positive airway pressure (CPAP) versus no intervention (control). [ Time Frame: 56 days ] [ Designated as safety issue: No ]
  • To examine whether 8 weeks of CPAP for OSA improves quality of life, insomnia, daytime sleepiness and fatigue, and health resource utilization in individuals with asthma. [ Time Frame: 56 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 46
Study Start Date: March 2007
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Control Group
8 weeks, no intervention for OSA
Active Comparator: CPAP group
8-week randomized-controlled period of CPAP treatment
Other: FDA-Approved Treatment
8 weeks of treatment with Continuous Positive Airway Pressure (CPAP)

  Eligibility

Ages Eligible for Study:   18 Years to 73 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • presence of not well-controlled (NWC) asthma (National Asthma Education and Prevention Program Guidelines step 2, 3, 4), as diagnosed by an asthma physician
  • stable doses of standard therapy for 2 months prior to enrollment. These regimens will include: inhaled corticosteroids (ICS) for mild-persistent step; ICS and inhaled long-acting β-adrenergics (LABA) or ICS and leukotriene modifier (LTMs) agents for moderate-persistent step; high doses of ICS, LABA or LTMs, with or without oral steroids at stable doses, for patients in severe step
  • adherence to the current asthma medications regimen, demonstration of a proper inhaler technique; agreement for maintaining the same asthma regimen (except rescue bronchodilators) as clinical condition permits (if an exacerbation occurs during the first 4-week period, the subject will be excluded as discussed below), and willingness to complete diaries of asthma symptoms, rescue bronchodilator use, peak flow meter (PEF) recordings as well as asthma-related urgent doctor's and emergency room visits and hospitalizations for the 3 months duration of the study
  • moderate to high probability for OSA (SA-SDQ scores ≥31 for males and ≥28 for females) or high clinical suspicion for OSA
  • preliminary agreement to treatment with continuous positive airway pressure (CPAP) if OSA is identified and current CPAP treatment criteria are met [patients with moderate to severe OSA (AHI>15 events/hour), patients with mild OSA (AHI 5-15 events/hour) in association with EDS or co-morbid conditions (HTN, stable ischemic heart disease, prior stroke, impaired cognition, mood disorders, insomnia
  • ability to read and write
  • ability and willingness to return to the Medical Center as required by the study protocol.

Exclusion Criteria:

  • asthma exacerbation in the prior 2 months
  • acute sinusitis
  • poorly controlled rhinitis or gastroesophageal reflux disease (GERD)
  • any unstable medical or psychiatric illness likely to impede participation in the protocol during the next year
  • evidence of co-existent lung disease, in particular allergic broncho-pulmonary aspergillosis or chronic obstructive pulmonary disease (COPD)
  • treated OSA or another primary sleep disorder
  • evidence of medical instability due to OSA at first sleep study visit
  • subjects with excessive daytime sleepiness to a degree that puts the subject or people around at risk of accidents (motor vehicle or work-related). In these cases we will facilitate expedited sleep evaluations through primary providers
  • historical evidence of collagen vascular disease
  • craniofacial abnormalities precluding the use of CPAP; 11) current cigarette smoking or within the prior 6 months (self-report and medical records
  • pregnancy (documented via urine-human chorionic gonadotropin detection test) or desire to become pregnant during the following 3 months
  • mental impairment limiting the ability to provide informed consent
  • current alcohol (as per the NIH cutoffs56 presented below) or recreational drug use (for both, based on medical records review and self-report without any prospective recording); women drinking more than 3 drinks at one time or more than 7 standard drinks a week or men drinking more than 4 drinks at one time or more than 14 standard drinks a week will be excluded. A standard drink is defined as one can or bottle of beer (12 fl oz), one glass of wine (5 fl oz), or one mixed drink containing 1.5 fl oz of hard liquor.
  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: NCT01026298

Contacts
Contact: Study Coordinator 608-256-1901 ext 11902
Contact: Mihaela Teodorescu, MD 608-256-1901 ext 11902 mt3@medicine.wisc.edu

Locations
United States, Wisconsin
Univeristy of Wisconsin Hospital and Clinics Recruiting
Madison, Wisconsin, United States, 53792
Principal Investigator: Mihaela Teodorescu, MD         
Sponsors and Collaborators
University of Wisconsin, Madison
Investigators
Principal Investigator: Mihaela Teodorescu, MD UW Madison
  More Information

No publications provided

Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT01026298     History of Changes
Other Study ID Numbers: H-2007-0034
Study First Received: December 2, 2009
Last Updated: February 11, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Wisconsin, Madison:
asthma
obstructive sleep apnea
severe asthma
OSA

Additional relevant MeSH terms:
Asthma
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Respiration Disorders
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on October 02, 2014