Determine the Relationship Between Circadian Rhythms and Nocturnal Asthma
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|ClinicalTrials.gov Identifier: NCT00891189|
Recruitment Status : Completed
First Posted : May 1, 2009
Last Update Posted : September 23, 2016
|Condition or disease|
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 :||Observational|
|Actual Enrollment :||20 participants|
|Observational Model:||Case Control|
|Official Title:||Circadian Rhythms and Nocturnal Asthma|
|Study Start Date :||January 2009|
|Actual Primary Completion Date :||December 2011|
|Actual Study Completion Date :||December 2011|
Healthy participants without asthma
2 Non-nocturnal asthma
Participants with non-nocturnal asthma
3 Nocturnal asthma
Participants with nocturnal asthma
- Spirometry [ Time Frame: Measured during the 28-hour constant routine testing ]
- 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 ]
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): NCT00891189
|United States, Illinois|
|Chicago, Illinois, United States, 60611|
|Principal Investigator:||Brandon S. Lu, MD, MS||Northwestern University|