Obstructive Sleep Apnea Syndrome Clinical Trial
Official title:
Randomized Cross-over Trials of the Effect of Heated Humidified CPAP Versus Non-humidified CPAP on Nasal Physiology
Verified date | April 2010 |
Source | University of Athens |
Contact | n/a |
Is FDA regulated | No |
Health authority | Greece: Ministry of Health and Welfare |
Study type | Observational |
Nasal continuous positive airway pressure can cause nasal side effects which can compromise compliance to therapy. Humidifiers can attenuate this effect. However, the mechanism by which humidified CPAP alleviates nasal symptoms has never been assessed objectively in OSA patients. Therefore, the purpose of this study is to examine the effect of humidified CPAP on nasal airway physiology with combined measurements of nasal resistance and level of inflammatory markers. The investigators' hypothesis is that the addition of heated humidification in CPAP decreases nasal airway resistance and nasal mucosal inflammation markers and thus, ameliorates nasal symptoms of OSAS patients.
Status | Completed |
Enrollment | 20 |
Est. completion date | June 2009 |
Est. primary completion date | March 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 80 Years |
Eligibility |
Inclusion Criteria: 1. Obstructive sleep apnea syndrome defined as apnea/hypopnoea index greater than 20, 2. Initiation of continuous positive airway pressure, and 3. Symptomatic nasal obstruction. Exclusion Criteria: 1. No medication known to influence nasal resistance (antihistamines, vasoconstrictors, vasodilators, topical or systemic steroids, and recreation drugs), 2. No smoking, 3. No upper or lower respiratory tract disease (e.g. upper respiratory tract infection, rhinitis, sinusitis, chronic obstructive pulmonary disease), including a history of nasal allergy. |
Observational Model: Case-Crossover, Time Perspective: Cross-Sectional
Country | Name | City | State |
---|---|---|---|
Greece | Department of Critical Care and Pulmonary Services, Evangelismos Hospital | Athens |
Lead Sponsor | Collaborator |
---|---|
University of Athens |
Greece,
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Togias AG, Naclerio RM, Proud D, Fish JE, Adkinson NF Jr, Kagey-Sobotka A, Norman PS, Lichtenstein LM. Nasal challenge with cold, dry air results in release of inflammatory mediators. Possible mast cell involvement. J Clin Invest. 1985 Oct;76(4):1375-81. — View Citation
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