- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00891189
Determine the Relationship Between Circadian Rhythms and Nocturnal Asthma
Circadian Rhythms and Nocturnal Asthma
Study Overview
Status
Conditions
Detailed Description
Nocturnal worsening of asthma, frequently called NA, is a common problem among some people with asthma and one that leads to increased morbidity and mortality. It is still unknown why lung function worsens at night in some asthmatics and not others. There is a possible relationship between NA, biological clocks, and circadian rhythms, but more research is needed to understand this relationship. Although the diurnal nature of NA has been shown repeatedly in studies, circadian rhythms have not yet been implicated as a related factor. This study will examine the pathophysiology of NA as it relates to circadian biology and will specifically explore physiological and molecular aspects.
This study will include people with asthma, people with NA, and healthy people. Potential participants will attend a screening visit to assess general health and severity of asthma, if present. They will also complete 2 weeks of diary recordings of their daily symptoms and airway function.
Eligible participants will then attend two study visits. The first study visit will last 1 hour and may include a methacholine challenge and bronchodilator testing, both of which will measure lung function. For 2 weeks before the second study visit, participants will keep records of their sleep patterns. The second study visit will be a hospital stay that will last for 2.5 days. While in the hospital, participants will undergo periodic blood draws and lung function testing. During waking hours, participants will remain quietly awake. During the first night, participants will be monitored while they sleep. During the second night, participants will stay awake for 28 hours, which will continue into the third day. Then, on the third day, participants will sleep for 8 hours while again being monitored. Upon waking, participants will be given a regular meal and discharged.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Illinois
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Chicago, Illinois, United States, 60611
- Northwestern University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria for People with Asthma:
- A physician diagnosis of asthma, consistent clinical history, and either 1) airway hyperresponsiveness indicated by a 20% or greater decrease in forced expiratory volume at one second (FEV1) in response to inhalation of methacholine at 8 mg/mL or less, or 2) bronchodilator-responsive expiratory airflow limitation (if FEV1 less than 70% of predicted value or less than 1.5 L, improving at least 200 mL and 12% in response to 180 μg of albuterol aerosol). Patients with NA should meet the above criteria and demonstrate an overnight decrease in peak flow of 20% or greater on at least four of seven nights at home.
Inclusion Criteria for all Participants:
- Able to follow directions
Exclusion Criteria for Participants with Asthma:
- Use of oral steroids within 2 weeks of study entry
- Use of cromolyn, leukotriene antagonist, or theophylline within 1 week of study entry
- History of cognitive or other neurological disorder
- Active symptoms of Diagnostic and Statistical Manual IV (DSM-IV) criteria for any major psychiatric disorder, alcohol abuse, or substance abuse
- History of, or concurrent, unstable or serious medical illness
- Shift work
- History or evidence of chronic obstructive pulmonary disease (COPD)
- Tobacco smoking within the last month, or history of smoking greater than 5 pack-years
- Pregnancy or the desire to become pregnant during the study period
- Hematocrit less than 30
- Worsening or unstable asthma that requires use of a bronchodilator for more than four times a day
Exclusion Criteria for all Participants:
- History of obstructive sleep apnea or a body mass index more than 36, or other sleep disorder as assessed by questioning or polysomnography (PSG)
- History of cognitive or other neurological disorder
- Currently meets DSM-IV criteria for any major psychiatric disorder, alcohol abuse, or substance abuse (as assessed by an interview)
- Concurrent unstable or serious medical illness (other than asthma)
- Current use of psychoactive medications, including antidepressants, anxiolytics, neuroleptics, anticonvulsants, hypnotics, and stimulant medications
- Shift work
- A daily caffeine intake greater than 4 cups per day
- Smoking
- Pregnancy or the desire to become pregnant during the study period
- Atrial fibrillation or paced heart rhythm
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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1 Control
Healthy participants without asthma
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2 Non-nocturnal asthma
Participants with non-nocturnal asthma
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3 Nocturnal asthma
Participants with nocturnal asthma
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Spirometry
Time Frame: Measured during the 28-hour constant routine testing
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Measured during the 28-hour constant routine testing
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Cortisol, melatonin, exhaled nitric oxide, inflammatory cytokine levels, clock gene expression, and heart rate variability
Time Frame: Measured during the 28-hour constant routine testing
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Measured during the 28-hour constant routine testing
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Brandon S. Lu, MD, MS, Northwestern University
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 637
- K23HL091508 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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